[ { "nct": "NCT00082381", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT00082407", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs biphasic insulin aspart.", "decided_by": "both_coders" }, { "nct": "NCT00097500", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs insulin glargine, both with metformin.", "decided_by": "both_coders" }, { "nct": "NCT00135330", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label: exenatide vs rosiglitazone is an active comparison; exenatide+rosiglitazone vs rosiglitazone has no placebo (open-label add-on).", "decided_by": "both_coders" }, { "nct": "NCT00294723", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Liraglutide vs glimepiride (double dummy); no placebo-only group.", "decided_by": "both_coders" }, { "nct": "NCT00308139", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide once weekly vs exenatide twice daily; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00318461", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "liraglutide" ], "background": "metformin (plus glimepiride placebo)" } ], "population": "type2_diabetes", "population_note": "", "note": "Met + Glim group (EG004) is an active comparator, left out. AE groups span the 26-week double-blind period plus an open-label extension to week 104 in which each arm continued its randomized treatment (placebo dropped); kept since arms stay as randomized, flag for second reader.", "decided_by": "both_coders" }, { "nct": "NCT00353834", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT00359762", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide vs glimepiride on metformin; AE groups are by study period, some not randomized; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00360334", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT00375492", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "lifestyle modification program" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00393718", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Liraglutide vs glibenclamide, double dummy.", "decided_by": "both_coders" }, { "nct": "NCT00395746", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "liraglutide" ], "background": "sulfonylurea" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00422058", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "AE groups cover weeks 0-104: the placebo group includes the open-label period after participants switched to liraglutide 2.4/3.0 mg (weeks 52-104), so it mixes exposures; orlistat is open-label active comparator. No clean placebo group.", "decided_by": "both_coders" }, { "nct": "NCT00434954", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs premixed insulin aspart.", "decided_by": "both_coders" }, { "nct": "NCT00500370", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "lifestyle modification plan" } ], "population": "overweight_obesity", "population_note": "", "note": "Non-diabetic obese adults.", "decided_by": "both_coders" }, { "nct": "NCT00516074", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00518115", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG002", "EG003", "EG004", "EG005", "EG006", "EG007", "EG008", "EG009" ], "placebo_groups": [ "EG000" ], "molecules": [ "albiglutide" ], "background": "diet/exercise or metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "Albiglutide (GSK716155) doses vs blinded weekly placebo. Exenatide BID (EG001) was an open-label active reference, not covered by the placebo, so left out.", "decided_by": "both_coders" }, { "nct": "NCT00518882", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Liraglutide vs exenatide; exenatide arm later switched to liraglutide.", "decided_by": "both_coders" }, { "nct": "NCT00546728", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "overweight_obesity", "population_note": "Abdominally obese adults with impaired glucose tolerance (prediabetes).", "note": "Open-label exenatide vs metformin.", "decided_by": "both_coders" }, { "nct": "NCT00560417", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Insulin lispro protamine vs glargine; exenatide is background in both arms.", "decided_by": "both_coders" }, { "nct": "NCT00577824", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "exenatide" ], "background": "oral antidiabetic drugs" } ], "population": "type2_diabetes", "population_note": "Japanese patients.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00603239", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "thiazolidinedione with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00614120", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Liraglutide vs glimepiride on metformin (double dummy); no placebo-only group.", "decided_by": "both_coders" }, { "nct": "NCT00620282", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "", "note": "Open-label glimepiride arm (EG002) left out.", "decided_by": "both_coders" }, { "nct": "NCT00630825", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "dulaglutide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "Overweight/obese adults with type 2 diabetes.", "note": "LY2189265 is dulaglutide.", "decided_by": "both_coders" }, { "nct": "NCT00637273", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide QW vs sitagliptin vs pioglitazone, double dummy on metformin.", "decided_by": "both_coders" }, { "nct": "NCT00641056", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide QW vs insulin glargine, open-label.", "decided_by": "both_coders" }, { "nct": "NCT00658021", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "exenatide" ], "background": "diet/exercise or oral antidiabetic agents" } ], "population": "type2_diabetes", "population_note": "Adolescents with type 2 diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00676338", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide QW vs metformin, sitagliptin, pioglitazone (double dummy).", "decided_by": "both_coders" }, { "nct": "NCT00688701", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG003", "EG004" ], "placebo_groups": [ "EG000", "EG001" ], "molecules": [ "lixisenatide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "Combined groups EG002 (placebo) and EG005 (lixisenatide) pool the individual arms and are left out to avoid double counting.", "decided_by": "both_coders" }, { "nct": "NCT00696657", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005", "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "semaglutide" ], "background": "metformin or diet and exercise" } ], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide groups (EG007, EG008) have no placebo, left out.", "decided_by": "both_coders" }, { "nct": "NCT00700817", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs sitagliptin on metformin.", "decided_by": "both_coders" }, { "nct": "NCT00701935", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00707031", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label lixisenatide vs exenatide on metformin.", "decided_by": "both_coders" }, { "nct": "NCT00712673", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG003", "EG004" ], "placebo_groups": [ "EG000", "EG001" ], "molecules": [ "lixisenatide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "Morning and evening arms used; combined groups EG002 and EG005 pool them and are left out.", "decided_by": "both_coders" }, { "nct": "NCT00713830", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "lixisenatide" ], "background": "sulfonylurea with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00715624", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "lixisenatide" ], "background": "basal insulin with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00734474", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "The placebo AE group (EG008) covers 104 weeks, switching to sitagliptin after week 26, so it mixes exposures; sitagliptin (EG007) is active. No clean placebo group.", "decided_by": "both_coders" }, { "nct": "NCT00763451", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG003", "EG004" ], "placebo_groups": [ "EG000", "EG001" ], "molecules": [ "lixisenatide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "Combined groups EG002 and EG005 pool the individual arms and are left out.", "decided_by": "both_coders" }, { "nct": "NCT00763815", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "lixisenatide" ], "background": "pioglitazone with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00765817", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "titrated insulin glargine with or without oral agents" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00775684", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "mixed", "population_note": "Impaired fasting glucose (prediabetes) or early type 2 diabetes.", "note": "Open-label exenatide vs sitagliptin vs glimepiride.", "decided_by": "both_coders" }, { "nct": "NCT00781937", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "energy-restricted diet after a low-calorie-diet run-in" } ], "population": "overweight_obesity", "population_note": "", "note": "Only those who lost >=5% of body weight in the low-calorie-diet run-in were randomized.", "decided_by": "both_coders" }, { "nct": "NCT00782418", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "exenatide" ], "background": "hyperglycemic clamp procedure" }, { "glp1_groups": [ "EG003", "EG004" ], "placebo_groups": [ "EG005" ], "molecules": [ "exenatide" ], "background": "graded glucose infusion procedure" } ], "population": "other", "population_note": "Healthy lean male volunteers.", "note": "Phase 1 methodology study; AE groups split by procedure (HGC, GGI), read as separate randomized panels. If the same people underwent both procedures the two comparisons overlap.", "decided_by": "both_coders" }, { "nct": "NCT00791479", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002", "EG003", "EG004" ], "placebo_groups": [ "EG005" ], "molecules": [ "dulaglutide" ], "background": "lifestyle measures" } ], "population": "type2_diabetes", "population_note": "", "note": "LY2189265 is dulaglutide. AE groups include a 3.0 mg group (EG004) not in the arm list; kept as a dulaglutide dose.", "decided_by": "both_coders" }, { "nct": "NCT00799435", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes with diastolic heart failure (normal ejection fraction).", "note": "Open-label exenatide vs usual care.", "decided_by": "both_coders" }, { "nct": "NCT00838903", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "albiglutide" ], "background": "metformin (plus sitagliptin and glimepiride placebos)" } ], "population": "type2_diabetes", "population_note": "", "note": "Sitagliptin (EG001) and glimepiride (EG002) groups are active comparators, left out.", "decided_by": "both_coders" }, { "nct": "NCT00838916", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label albiglutide vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT00839527", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "albiglutide" ], "background": "metformin and glimepiride (plus pioglitazone placebo)" } ], "population": "type2_diabetes", "population_note": "", "note": "Pioglitazone group (EG001) is an active comparator, left out.", "decided_by": "both_coders" }, { "nct": "NCT00845182", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Title says type 2 diabetic patients; conditions also list healthy and impaired glucose tolerance.", "note": "Pioglitazone vs exenatide vs pioglitazone + exenatide, no placebo; exenatide vs pioglitazone is active, exenatide + pioglitazone vs pioglitazone is an unblinded add-on.", "decided_by": "both_coders" }, { "nct": "NCT00845507", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "olanzapine" } ], "population": "other", "population_note": "Obese adults with olanzapine-associated weight gain and bipolar disorder, major depressive disorder, schizophrenia or schizoaffective disorder; diabetes status not stated.", "note": "", "decided_by": "third_reader" }, { "nct": "NCT00849017", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "albiglutide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "", "note": "50 mg group was up-titrated from 30 mg at week 12; background therapy not described.", "decided_by": "both_coders" }, { "nct": "NCT00849056", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "albiglutide" ], "background": "pioglitazone with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00855439", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes with diabetic peripheral neuropathy.", "note": "Open-label exenatide vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT00856609", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "not stated (metabolic chamber assessments)" } ], "population": "overweight_obesity", "population_note": "Non-diabetic obese adults.", "note": "Double-blind exenatide vs placebo. The intervention lists differ (weight loss behavioral listed for exenatide, metabolic chamber for placebo); read as data-entry quirks of study procedures, not different co-interventions. Flag for second reader.", "decided_by": "both_coders" }, { "nct": "NCT00856986", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Liraglutide + metformin in every arm after a run-in; trial tests adding insulin detemir. Non-randomized and run-in groups too.", "decided_by": "both_coders" }, { "nct": "NCT00866658", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "lixisenatide" ], "background": "basal insulin with or without sulfonylurea" } ], "population": "type2_diabetes", "population_note": "Asian patients.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00870194", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide in both arms; trial tests sitagliptin vs placebo added to exenatide.", "decided_by": "both_coders" }, { "nct": "NCT00877890", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide once weekly vs twice daily, open-label.", "decided_by": "both_coders" }, { "nct": "NCT00882050", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "exenatide" ], "background": "surgery under general anesthesia" } ], "population": "other", "population_note": "Surgical patients, intravenous infusion for perioperative hyperglycemia; diabetes status not stated.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00894322", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "exenatide" ], "background": "diet and exercise, metformin and/or thiazolidinedione" } ], "population": "type2_diabetes", "population_note": "", "note": "Cohort 2 randomized exenatide once-weekly suspension vs MCT-diluent placebo. Cohort 1 (EG000) is a single dose in healthy volunteers with no placebo, left out.", "decided_by": "both_coders" }, { "nct": "NCT00905255", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese patients.", "note": "Open-label lixisenatide two-step vs one-step titration; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00917267", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Asian patients.", "note": "Open-label exenatide once weekly vs twice daily.", "decided_by": "both_coders" }, { "nct": "NCT00935532", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide once weekly vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT00943917", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label ITCA 650 (implanted exenatide) vs exenatide injection; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00960661", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs insulin lispro, both with glargine and metformin.", "decided_by": "both_coders" }, { "nct": "NCT00975286", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "lixisenatide" ], "background": "insulin glargine and metformin with or without thiazolidinedione" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00976391", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label albiglutide vs prandial insulin lispro, both with insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT00976937", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Obese type 2 diabetes, under 50 years.", "note": "Lixisenatide vs sitagliptin, double dummy, on metformin.", "decided_by": "both_coders" }, { "nct": "NCT01001104", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "dulaglutide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "Japanese patients.", "note": "LY2189265 is dulaglutide.", "decided_by": "both_coders" }, { "nct": "NCT01003184", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide once weekly vs insulin detemir.", "decided_by": "both_coders" }, { "nct": "NCT01029886", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide once weekly vs liraglutide.", "decided_by": "both_coders" }, { "nct": "NCT01064687", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "dulaglutide" ], "background": "metformin and pioglitazone" } ], "population": "type2_diabetes", "population_note": "", "note": "Uses the baseline-to-week-26 groups, while placebo was given. Exenatide BID (EG002, EG006) is an active comparator whose regimen the once-weekly placebo doesn't match, left out. Through-week-56 groups (EG004-EG006) and the placebo-to-dulaglutide groups (EG007, EG008) are after placebo participants switched, left out.", "decided_by": "both_coders" }, { "nct": "NCT01075282", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label dulaglutide (LY2189265) vs insulin glargine on metformin and glimepiride.", "decided_by": "both_coders" }, { "nct": "NCT01089569", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs insulin glargine vs both; exenatide + glargine vs glargine is an unblinded add-on with no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01098461", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "albiglutide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "Japanese patients.", "note": "Albiglutide (GSK716155) arms are labelled active comparator but are the study drug; every-other-week group got placebo in alternate weeks.", "decided_by": "both_coders" }, { "nct": "NCT01098539", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes with renal impairment.", "note": "Albiglutide vs sitagliptin, double dummy.", "decided_by": "both_coders" }, { "nct": "NCT01104701", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide once monthly vs exenatide once weekly reference; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01107717", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "New-onset type 2 diabetes.", "note": "Open-label metformin + pioglitazone + exenatide vs conventional sequential therapy (metformin, glyburide, glargine); the GLP-1 group also gets pioglitazone the comparator doesn't.", "decided_by": "both_coders" }, { "nct": "NCT01117350", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label insulin glargine vs liraglutide; extension group (EG002) is glargine after liraglutide.", "decided_by": "both_coders" }, { "nct": "NCT01126580", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Early type 2 diabetes.", "note": "Dulaglutide (LY2189265) vs metformin, double dummy.", "decided_by": "both_coders" }, { "nct": "NCT01128894", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label albiglutide vs liraglutide.", "decided_by": "both_coders" }, { "nct": "NCT01136798", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "exenatide" ], "background": "usual type 2 diabetes medications" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with sleep-disordered breathing.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01144338", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "exenatide" ], "background": "usual care (not stated)" } ], "population": "type2_diabetes", "population_note": "", "note": "Cardiovascular outcomes trial; only serious adverse events were collected.", "decided_by": "both_coders" }, { "nct": "NCT01147250", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "lixisenatide" ], "background": "usual care (not stated)" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes after an acute coronary syndrome (condition field lists only acute coronary syndrome).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01147627", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Newly diagnosed, drug-naive type 2 diabetes.", "note": "Open-label exenatide vs premixed insulin lispro vs pioglitazone.", "decided_by": "both_coders" }, { "nct": "NCT01149421", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "dulaglutide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "", "note": "LY2189265 is dulaglutide.", "decided_by": "both_coders" }, { "nct": "NCT01154933", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "insulin" } ], "population": "type2_diabetes", "population_note": "Obese type 2 diabetes on insulin.", "note": "Single-blind saline placebo. The one exenatide AE group (5 then 10 mcg) appears to pool the two exenatide arms. Record says no adverse events occurred.", "decided_by": "both_coders" }, { "nct": "NCT01169779", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "lixisenatide" ], "background": "metformin with or without sulfonylurea" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01175473", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label lixisenatide vs liraglutide on metformin.", "decided_by": "both_coders" }, { "nct": "NCT01179048", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "standard care (not stated)" } ], "population": "type2_diabetes", "population_note": "", "note": "Cardiovascular outcomes trial.", "decided_by": "both_coders" }, { "nct": "NCT01191268", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label dulaglutide (LY2189265) vs insulin glargine, both with insulin lispro.", "decided_by": "both_coders" }, { "nct": "NCT01206101", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "islet cell transplantation and standard care" } ], "population": "type1_diabetes", "population_note": "Type 1 diabetes undergoing islet cell transplantation.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01232946", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs insulin detemir vs both, on metformin; liraglutide + detemir vs detemir is an unblinded add-on with no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01234649", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "metformin XR" } ], "population": "overweight_obesity", "population_note": "Overweight/obese women with metabolic defects and recent gestational diabetes; conditions also list type 2 diabetes and impaired glucose tolerance, read as a prevention population.", "note": "Metformin + placebo arm is labelled active comparator but is the liraglutide placebo control.", "decided_by": "both_coders" }, { "nct": "NCT01237197", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "overweight_obesity", "population_note": "Children/adolescents with extreme obesity.", "note": "Placebo AE group (EG001) includes 3 months of open-label exenatide after placebo, so it mixes exposures; no clean placebo group.", "decided_by": "both_coders" }, { "nct": "NCT01255163", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "none" } ], "population": "other", "population_note": "Alzheimer's disease or mild cognitive impairment.", "note": "Exendin-4 is exenatide.", "decided_by": "both_coders" }, { "nct": "NCT01269047", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type1_diabetes", "population_note": "Children with type 1 diabetes.", "note": "Open-label exenatide + insulin vs pramlintide + insulin vs insulin alone; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01272219", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "prediabetes stratum, 160 weeks" }, { "glp1_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "liraglutide" ], "background": "no-prediabetes stratum, 68 weeks" } ], "population": "overweight_obesity", "population_note": "Obese, or overweight with comorbidities, without diabetes; randomized in prediabetes and no-prediabetes strata.", "note": "Two strata reported separately. EG002 pools arms 1A and 1B: after 56 weeks of liraglutide half were re-randomized to placebo for weeks 56-68, so a minority of its exposure is off drug; kept as the randomized liraglutide arm, flag for second reader. AE note says 37 prediabetic subjects wrongly entered the re-randomization and are counted in EG000/EG001.", "decided_by": "both_coders" }, { "nct": "NCT01272232", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "liraglutide" ], "background": "hypocaloric diet and exercise plus pre-trial metformin, glitazone and/or sulfonylurea" } ], "population": "type2_diabetes", "population_note": "Overweight or obese adults with type 2 diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01296412", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label sitagliptin (+/- glimepiride) vs liraglutide on metformin.", "decided_by": "both_coders" }, { "nct": "NCT01324388", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dulaglutide" ], "background": "lisinopril" } ], "population": "other", "population_note": "Part 1: people with hypertension on lisinopril (condition field lists type 2 diabetes; diabetes status not stated). Part 2: healthy volunteers.", "note": "Phase 1. Part 1 randomized dulaglutide (LY2189265) vs placebo, both with lisinopril. Part 2 groups (EG002-EG004) are crossover periods with metoprolol and no placebo, left out.", "decided_by": "both_coders" }, { "nct": "NCT01336023", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label insulin degludec vs degludec/liraglutide vs liraglutide; liraglutide vs degludec is active, degludec/liraglutide vs degludec is open-label with no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01357889", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Albiglutide from two manufacturing processes; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01364584", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "not stated" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01388361", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs insulin aspart, both added to insulin degludec + metformin; IDeg group (EG000) not randomized.", "decided_by": "both_coders" }, { "nct": "NCT01392573", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "titrated insulin degludec and metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "Double-blind fixed-ratio insulin degludec/liraglutide vs insulin degludec alone: the comparator gets the same insulin, so the arms differ only in liraglutide (no added drug, double-blind). Insulin doses are titrated in each arm. Flag for second reader.", "decided_by": "both_coders" }, { "nct": "NCT01394952", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "dulaglutide" ], "background": "usual diabetes care (not specified)" } ], "population": "type2_diabetes", "population_note": "", "note": "Cardiovascular outcomes trial; background glucose-lowering care not described in record.", "decided_by": "both_coders" }, { "nct": "NCT01432405", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label: exenatide + pioglitazone vs pioglitazone alone, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01473953", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG004" ], "molecules": [ "liraglutide" ], "background": "none (single dose)" } ], "population": "other", "population_note": "Healthy male volunteers (official title), though conditions list diabetes.", "note": "Liraglutide-depot (sustained-release liraglutide lysine), single-dose escalation cohorts pooled against pooled placebo.", "decided_by": "both_coders" }, { "nct": "NCT01475734", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "albiglutide" ], "background": "stepped glucose clamp procedure" } ], "population": "type2_diabetes", "population_note": "", "note": "Single dose 3 days before clamp; albiglutide arm labelled active comparator but is the test drug.", "decided_by": "both_coders" }, { "nct": "NCT01476475", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label insulin glargine/lixisenatide fixed-ratio combination vs insulin glargine alone (both on metformin); no placebo for lixisenatide.", "decided_by": "both_coders" }, { "nct": "NCT01505673", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "high-dose insulin" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with obesity on high-dose insulin.", "note": "Saline placebo injection; insulin background inferred from title.", "decided_by": "both_coders" }, { "nct": "NCT01512108", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide + OAD vs an additional OAD.", "decided_by": "both_coders" }, { "nct": "NCT01514149", "eligible": false, "exclusion_reason": "no_glp1_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "CJC-1134-PC is named only by code; it is not on the codebook list and the record never describes it as a GLP-1 receptor agonist. Were it so described, EG000-EG003 vs EG004 on metformin would be a clean comparison.", "decided_by": "third_reader" }, { "nct": "NCT01517412", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Lixisenatide before main meal vs before breakfast; both arms get lixisenatide, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01524705", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Exenatide vs prandial insulin, both on glargine + metformin.", "decided_by": "both_coders" }, { "nct": "NCT01541215", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "type2_diabetes", "population_note": "Children and adolescents with type 2 diabetes.", "note": "Liraglutide AE group spans 52 weeks (26-week double-blind plus 26-week open-label extension) while placebo was given only for 26 weeks; follow-up groups are liraglutide only. No AE group pair covers the same randomized double-blind period.", "decided_by": "both_coders" }, { "nct": "NCT01554618", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "not specified" } ], "population": "type2_diabetes", "population_note": "Adolescents with type 2 diabetes.", "note": "Controlled assessment period groups only; extension groups EG002/EG003 excluded (open-label, placebo switched to exenatide). Exenatide once weekly.", "decided_by": "both_coders" }, { "nct": "NCT01557166", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "500 kcal/day-deficit diet and exercise" } ], "population": "overweight_obesity", "population_note": "Obesity with moderate or severe obstructive sleep apnoea; diabetes status not stated.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01558271", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes (monotherapy).", "note": "Placebo AE group is Placebo/dulaglutide (26 weeks placebo then 26 weeks open-label dulaglutide), and dulaglutide group spans the open-label period too; no group covers only the blinded placebo period. Liraglutide arm is open-label active comparator.", "decided_by": "both_coders" }, { "nct": "NCT01572740", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "pre-trial insulin therapy" } ], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01584232", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label dulaglutide vs insulin glargine, both on oral agents.", "decided_by": "both_coders" }, { "nct": "NCT01590433", "eligible": false, "exclusion_reason": "background_differs", "comparisons": [], "population": "overweight_obesity", "population_note": "Overweight and obese women without diabetes.", "note": "Only the placebo arm lists dietary counseling as an intervention, its group says participants 'may or may not be asked to follow a reduced calorie diet', and the truncated arm texts diverge ('exenatide will not be as[ked]...' vs 'placebo will be assigned...'): placebo participants appear to have been assigned a reduced-calorie diet the exenatide group wasn't. If the diets were in fact identical, EG000 vs EG001 would be clean.", "decided_by": "third_reader" }, { "nct": "NCT01596504", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label lixisenatide vs liraglutide 1.2 or 1.8 mg; all arms get a GLP-1 receptor agonist, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01617434", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "basal insulin analogue with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01618162", "eligible": false, "exclusion_reason": "glp1_combined_with_other_active", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "IDegLira (insulin degludec/liraglutide fixed combination) vs placebo, on sulphonylurea with or without metformin.", "decided_by": "both_coders" }, { "nct": "NCT01620489", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "stable pre-trial OADs and/or insulin" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with moderate renal impairment.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01621178", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes with moderate or severe chronic kidney disease.", "note": "Open-label dulaglutide vs insulin glargine, all on insulin lispro.", "decided_by": "both_coders" }, { "nct": "NCT01624259", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "AWARD-6: open-label dulaglutide vs liraglutide on metformin; both arms GLP-1 receptor agonists, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01644500", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Double-dummy dulaglutide vs glimepiride.", "decided_by": "both_coders" }, { "nct": "NCT01648582", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label dulaglutide vs insulin glargine on metformin and/or sulfonylurea.", "decided_by": "both_coders" }, { "nct": "NCT01652716", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide once-weekly suspension vs exenatide twice daily; both arms exenatide, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01652729", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide QW injection vs sitagliptin vs oral placebo capsule. The placebo is a dummy for sitagliptin, not for exenatide, and exenatide was given open-label, so the placebo group is not a placebo for the GLP-1 drug in a blinded design. Sitagliptin group is an active comparator.", "decided_by": "both_coders" }, { "nct": "NCT01664247", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Insulin degludec vs placebo, both added to liraglutide 1.8 mg + metformin.", "decided_by": "both_coders" }, { "nct": "NCT01664624", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes on metformin.", "note": "Open-label exenatide is an active comparator for roflumilast/alogliptin arms; no placebo for exenatide.", "decided_by": "both_coders" }, { "nct": "NCT01667900", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG005", "EG006", "EG007" ], "placebo_groups": [ "EG004" ], "molecules": [ "dulaglutide" ], "background": "none stated" } ], "population": "mixed", "population_note": "Part A healthy Chinese volunteers, Part B Chinese patients with type 2 diabetes; the comparison is Part B (type 2 diabetes) only.", "note": "Part A groups (EG000-EG003) are single doses given 'in 1 of 3 treatment periods', so each participant had several treatments and the groups overlap; left out. Part B is parallel, weekly for 4 weeks.", "decided_by": "third_reader" }, { "nct": "NCT01676116", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "DUAL III: open-label IDegLira vs continued liraglutide or exenatide, both on OADs; every arm gets a GLP-1 receptor agonist and there is no placebo (IDegLira also adds insulin).", "decided_by": "both_coders" }, { "nct": "NCT01720446", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002", "EG003" ], "molecules": [ "semaglutide" ], "background": "standard-of-care treatment" } ], "population": "type2_diabetes", "population_note": "", "note": "SUSTAIN 6; dose-matched placebo volumes pooled.", "decided_by": "both_coders" }, { "nct": "NCT01722240", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "insulin (type 1 diabetes care)" } ], "population": "type1_diabetes", "population_note": "", "note": "AE note says safety collection spans 4 weeks before randomization plus 52 weeks after; run-in shared by both arms, kept. Insulin background inferred from population.", "decided_by": "both_coders" }, { "nct": "NCT01722266", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "liraglutide" ], "background": "insulin (type 1 diabetes care)" } ], "population": "type1_diabetes", "population_note": "", "note": "Liraglutide 0.6/1.2/1.8 mg pooled; placebo pooled across matched volumes. Insulin background inferred from population.", "decided_by": "both_coders" }, { "nct": "NCT01725126", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "mixed", "population_note": "Part A healthy volunteers; Parts B and C type 2 diabetes (conditions list obesity).", "note": "GSK2890457 vs placebo; in Part B both arms take liraglutide as background. No GLP-1 vs placebo comparison.", "decided_by": "both_coders" }, { "nct": "NCT01733758", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes (monotherapy).", "note": "Placebo group covers only weeks 0-24 (then switched to albiglutide, EG001), while albiglutide groups EG002/EG003 cover weeks 0-52, so no GLP-1 and placebo groups share a period. Liraglutide arm is open-label active comparator.", "decided_by": "both_coders" }, { "nct": "NCT01753362", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "liraglutide" ], "background": "insulin (type 1 diabetes care)" } ], "population": "type1_diabetes", "population_note": "Overweight adults with type 1 diabetes.", "note": "Insulin background inferred from population.", "decided_by": "both_coders" }, { "nct": "NCT01768559", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label lixisenatide vs insulin glulisine QD or TID, on glargine with or without metformin.", "decided_by": "both_coders" }, { "nct": "NCT01769378", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dulaglutide" ], "background": "glimepiride" } ], "population": "type2_diabetes", "population_note": "", "note": "AWARD-8.", "decided_by": "both_coders" }, { "nct": "NCT01777282", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes.", "note": "Open-label; every group gets albiglutide, split by background OAD; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01779362", "eligible": false, "exclusion_reason": "glp1_combined_with_other_active", "comparisons": [], "population": "mixed", "population_note": "Adults with prediabetes (impaired glucose tolerance) or recently diagnosed type 2 diabetes.", "note": "RISE: liraglutide group also gets metformin, which the placebo group doesn't; metformin-alone group is blinded to placebo but not to liraglutide, so liraglutide vs metformin-alone is open-label with no liraglutide placebo.", "decided_by": "both_coders" }, { "nct": "NCT01784965", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "calorie-restricted dietary weight-loss intervention" } ], "population": "overweight_obesity", "population_note": "Older adults with prediabetes (with excess weight implied by the weight-loss aim).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01794143", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "GRADE: open-label liraglutide vs glargine, glimepiride, sitagliptin on metformin; EG004 is the run-in.", "decided_by": "both_coders" }, { "nct": "NCT01798264", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label ITCA 650 (implanted exenatide) dose groups only; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01798706", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "lixisenatide" ], "background": "basal insulin and/or oral antidiabetic treatment" } ], "population": "type2_diabetes", "population_note": "Older adults with type 2 diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01800968", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "standard heart failure care (not specified)" } ], "population": "other", "population_note": "Acute (advanced) heart failure; diabetes not required by the record.", "note": "Only serious adverse events were reported (non-serious AEs not collected).", "decided_by": "both_coders" }, { "nct": "NCT01836523", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "liraglutide" ], "background": "pre-trial insulin treatment" } ], "population": "type1_diabetes", "population_note": "", "note": "Three liraglutide doses pooled against pooled dose-matched placebo.", "decided_by": "both_coders" }, { "nct": "NCT01847313", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Diabetic kidney disease; diabetes type not stated (liraglutide add-on to standard diabetes care suggests type 2).", "note": "Open-label liraglutide vs no-intervention standard care control.", "decided_by": "both_coders" }, { "nct": "NCT01870297", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "LY3025876 is not described as a GLP-1 receptor agonist, so Part A has no GLP-1 group. In Part B, EG006 got the LY3025876 placebo plus liraglutide as a separate injection after a 2-week titration, and EG005 got the same LY3025876 placebo with no liraglutide dummy: the placebo is background shared by both, liraglutide was unmasked, and its group had 2 extra weeks of treatment.", "decided_by": "third_reader" }, { "nct": "NCT01885208", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "SUSTAIN 3: open-label semaglutide vs exenatide ER, both GLP-1 receptor agonists on OADs; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01907854", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Double-dummy liraglutide vs sitagliptin on metformin.", "decided_by": "both_coders" }, { "nct": "NCT01917656", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs sulphonylurea on metformin during Ramadan.", "decided_by": "both_coders" }, { "nct": "NCT01919489", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs insulin glargine, both with OADs, after hospital discharge.", "decided_by": "both_coders" }, { "nct": "NCT01923181", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002", "EG003", "EG004", "EG005", "EG006" ], "placebo_groups": [ "EG008" ], "molecules": [ "semaglutide" ], "background": "metformin or diet and exercise alone" } ], "population": "type2_diabetes", "population_note": "", "note": "Oral semaglutide dose groups pooled against oral placebo tablets. Subcutaneous semaglutide (EG007) was an open-label reference arm with no matching placebo, so left out.", "decided_by": "both_coders" }, { "nct": "NCT01928329", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "insulin (type 1 diabetes care)" } ], "population": "type1_diabetes", "population_note": "", "note": "Exenatide once weekly (Bydureon). Insulin background inferred from population.", "decided_by": "both_coders" }, { "nct": "NCT01930188", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "SUSTAIN 2: double-dummy semaglutide vs sitagliptin on metformin and/or TZD.", "decided_by": "both_coders" }, { "nct": "NCT01951651", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label exenatide vs glipizide.", "decided_by": "both_coders" }, { "nct": "NCT01952145", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "DUAL V: open-label IDegLira (also adds insulin degludec) vs insulin glargine, on metformin.", "decided_by": "both_coders" }, { "nct": "NCT01966978", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "SIMPLE: open-label liraglutide vs insulin aspart, both on detemir + metformin.", "decided_by": "both_coders" }, { "nct": "NCT01973231", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs lixisenatide on metformin; both GLP-1 receptor agonists, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01982630", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "mixed", "population_note": "Type 2 diabetes in Parts 1 and 2, plus a non-diabetic overweight/obese MK-8521 cohort in Part 2.", "note": "AE groups split each arm by titration dose period (e.g. liraglutide 0.6 mg days 1-2, 1.2 mg days 3-7, 1.8 mg days 8-14), so they are within-arm periods, not whole randomized arms; liraglutide is an active comparator against placebo for MK-8521. MK-8521 is not described as a GLP-1 receptor agonist in the record.", "decided_by": "both_coders" }, { "nct": "NCT02008682", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs sitagliptin on metformin.", "decided_by": "both_coders" }, { "nct": "NCT02014740", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "Open-label liraglutide (with metformin) vs metformin alone titrated to target; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02020616", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "exenatide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "LY3053102 is not described as a GLP-1 receptor agonist, so its groups (EG001-EG005) are left out. Exenatide ER (labelled active comparator) vs the LY3053102-matched placebo, both weekly SC on metformin for 12 weeks, triple-masked; the exenatide arm lists no LY3053102 placebo, so the placebo stands in for active treatment. No LY3053102 + exenatide group was reported.", "decided_by": "third_reader" }, { "nct": "NCT02054897", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "none (drug-naive, diet and exercise)" } ], "population": "type2_diabetes", "population_note": "", "note": "SUSTAIN 1; two placebo volumes pooled by the sponsor.", "decided_by": "both_coders" }, { "nct": "NCT02058147", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "LixiLan-O: open-label insulin glargine/lixisenatide FRC vs glargine vs lixisenatide on metformin; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02058160", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "LixiLan-L: open-label insulin glargine/lixisenatide FRC vs insulin glargine (with or without metformin); no placebo for lixisenatide.", "decided_by": "both_coders" }, { "nct": "NCT02060383", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "other", "population_note": "Pasireotide-induced hyperglycemia in Cushing's disease or acromegaly.", "note": "Open-label incretin strategy (sitagliptin, switched to liraglutide if uncontrolled; mixes exposures) vs insulin; other groups non-randomized.", "decided_by": "both_coders" }, { "nct": "NCT02072096", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Older adults with type 2 diabetes.", "note": "IMPERIUM: open-label treatment strategies with investigator-chosen drugs (GLP-1 RA optional in strategy A) vs glimepiride/glargine strategy; groups mix exposures.", "decided_by": "both_coders" }, { "nct": "NCT02073929", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none" } ], "population": "other", "population_note": "Women with polycystic ovary syndrome.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02098395", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "liraglutide" ], "background": "pre-trial insulin (capped)" } ], "population": "type1_diabetes", "population_note": "", "note": "Three liraglutide doses pooled against three pooled placebo volumes.", "decided_by": "both_coders" }, { "nct": "NCT02100475", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "IDegLira dose increase vs IDegLira + insulin aspart, both on metformin; liraglutide (in IDegLira) in every arm.", "decided_by": "both_coders" }, { "nct": "NCT02119819", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Placebo group got placebo injections for only 12 weeks and no injections for weeks 12-24 (mixes placebo with unblinded no treatment), while LY2944876 (an oxyntomodulin analog, a GLP-1/glucagon receptor co-agonist) and exenatide ER groups were treated for 24 weeks; no GLP-1 and placebo groups share a placebo-controlled period. If a second reader accepts the placebo group, the GLP-1 groups would be EG000-EG004 vs EG005 on metformin.", "decided_by": "both_coders" }, { "nct": "NCT02128932", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "SUSTAIN 4: open-label semaglutide vs insulin glargine on metformin with or without sulphonylurea.", "decided_by": "both_coders" }, { "nct": "NCT02152371", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dulaglutide" ], "background": "titrated insulin glargine with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "AWARD-9.", "decided_by": "both_coders" }, { "nct": "NCT02160990", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "Obesity with accelerated gastric emptying; diabetes status not stated.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02207374", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes.", "note": "Open-label semaglutide vs one additional OAD.", "decided_by": "both_coders" }, { "nct": "NCT02229227", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label albiglutide + glargine vs insulin lispro + glargine.", "decided_by": "both_coders" }, { "nct": "NCT02229383", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "titrated insulin glargine with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "Exenatide once weekly; conditions say diabetes mellitus but title specifies type 2.", "decided_by": "both_coders" }, { "nct": "NCT02229396", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "exenatide" ], "background": "dapagliflozin + metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "DURATION-8: exenatide + dapagliflozin vs exenatide placebo + dapagliflozin differ only in exenatide. Exenatide + dapagliflozin placebo (EG002) has no matching placebo-only group, so left out.", "decided_by": "both_coders" }, { "nct": "NCT02251431", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "not specified" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with chronic kidney disease and left ventricular diastolic dysfunction (type 4 cardiorenal syndrome).", "note": "Cohort A double-blind groups; open-label cohort B has no AE group here. Exenatide ER (Bydureon).", "decided_by": "both_coders" }, { "nct": "NCT02254291", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes.", "note": "Open-label semaglutide vs sitagliptin monotherapy.", "decided_by": "both_coders" }, { "nct": "NCT02284009", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "albiglutide" ], "background": "insulin" } ], "population": "type1_diabetes", "population_note": "New-onset type 1 diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02288273", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "Exenatide once weekly (Bydureon).", "decided_by": "both_coders" }, { "nct": "NCT02298192", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "IDegLira with once-weekly vs twice-weekly titration, on metformin with or without pioglitazone; every arm gets IDegLira, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02299388", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "low-sodium diet advice" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with hypertension.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02305381", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "basal insulin with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "SUSTAIN 5; placebo volumes pooled by the sponsor.", "decided_by": "both_coders" }, { "nct": "NCT02417142", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "existing antipsychotic treatment" } ], "population": "other", "population_note": "Schizophrenia or schizoaffective disorder.", "note": "Exenatide 2 mg once weekly added to existing treatment.", "decided_by": "both_coders" }, { "nct": "NCT02420262", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "DUAL VII: open-label IDegLira vs insulin glargine + insulin aspart.", "decided_by": "both_coders" }, { "nct": "NCT02443155", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "liraglutide" ], "background": "NNC0114-0006 placebo and pre-trial insulin" }, { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "NNC0114-0006 (anti-IL-21) and pre-trial insulin" } ], "population": "type1_diabetes", "population_note": "Adults with newly diagnosed type 1 diabetes.", "note": "Double-dummy factorial: one comparison per NNC0114-0006 background. AE window includes a 26-week off-treatment follow-up in every group.", "decided_by": "both_coders" }, { "nct": "NCT02453711", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002", "EG003", "EG004", "EG005", "EG006", "EG007" ], "placebo_groups": [ "EG008" ], "molecules": [ "semaglutide", "liraglutide" ], "background": "none stated" } ], "population": "overweight_obesity", "population_note": "Adults with obesity without diabetes.", "note": "Once-daily semaglutide doses and liraglutide 3.0 mg (labelled active comparator but with its own matching placebo arm) against a single pooled placebo matched to all active arms, so all GLP-1 groups share one comparison.", "decided_by": "both_coders" }, { "nct": "NCT02455076", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Hospitalized patients with type 2 diabetes.", "note": "Open-label exenatide (alone or with glargine) vs basal-bolus or insulin-only regimens.", "decided_by": "both_coders" }, { "nct": "NCT02461589", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002", "EG003", "EG009", "EG004", "EG005", "EG006", "EG007" ], "placebo_groups": [ "EG008" ], "molecules": [ "semaglutide", "liraglutide" ], "background": "not specified" } ], "population": "type2_diabetes", "population_note": "", "note": "Once-daily semaglutide doses and liraglutide doses (labelled active comparator, but placebo was volume-matched to both) against one pooled placebo, so all GLP-1 groups share one comparison.", "decided_by": "both_coders" }, { "nct": "NCT02465515", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "albiglutide" ], "background": "standard care for diabetes and cardiovascular health" } ], "population": "type2_diabetes", "population_note": "", "note": "Harmony Outcomes. Conditions say diabetes mellitus but title specifies type 2. Non-serious AEs were collected only partly (pre-specified interest systematically, others non-systematically).", "decided_by": "both_coders" }, { "nct": "NCT02492763", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes on metformin.", "note": "Liraglutide was open-label, and the placebo is matched to MK-8521, so there is no placebo for liraglutide in a blinded design. The record does not describe MK-8521's mechanism; if a second reader counts it as a GLP-1 receptor agonist (it is reported elsewhere as a GLP-1/glucagon co-agonist), EG000+EG001 vs EG002 on metformin would be clean.", "decided_by": "both_coders" }, { "nct": "NCT02496611", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "exenatide" ], "background": "lifestyle weight-loss maintenance after meal-replacement induction" } ], "population": "overweight_obesity", "population_note": "Adolescents with severe obesity; diabetes status not stated.", "note": "Exenatide ER (Bydureon) per title. EG002 is the pre-randomization meal-replacement induction group, left out.", "decided_by": "both_coders" }, { "nct": "NCT02501161", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "DUAL VIII: open-label IDegLira vs insulin glargine on OADs.", "decided_by": "both_coders" }, { "nct": "NCT02505334", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes.", "note": "Open-label liraglutide 1.8 vs 0.9 mg/day after a liraglutide run-in; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02518945", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "type1_diabetes", "population_note": "", "note": "Dapagliflozin vs placebo, both on liraglutide + insulin.", "decided_by": "both_coders" }, { "nct": "NCT02527200", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "other", "population_note": "Children and adolescents with Prader-Willi syndrome and obesity.", "note": "Liraglutide groups cover 52 weeks while placebo was given only for 16 weeks; liraglutide groups therefore extend past the placebo-controlled period, and no groups share a period.", "decided_by": "both_coders" }, { "nct": "NCT02548585", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "none (cohort 1, 7 days)" }, { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "cotadutide" ], "background": "none (cohort 2, 11 days)" }, { "glp1_groups": [ "EG005" ], "placebo_groups": [ "EG004" ], "molecules": [ "cotadutide" ], "background": "none (cohort 3, 15 days)" }, { "glp1_groups": [ "EG007" ], "placebo_groups": [ "EG006" ], "molecules": [ "cotadutide" ], "background": "none (cohort 4, 41 days)" }, { "glp1_groups": [ "EG009" ], "placebo_groups": [ "EG008" ], "molecules": [ "cotadutide" ], "background": "none (cohort 5, 22 days)" }, { "glp1_groups": [ "EG011" ], "placebo_groups": [ "EG010" ], "molecules": [ "cotadutide" ], "background": "none (cohort 6, 17 days)" } ], "population": "type2_diabetes", "population_note": "Overweight or obese adults with type 2 diabetes.", "note": "MEDI0382 is cotadutide (named only by code in the record; it is the sole study drug of a trial found by a GLP-1 receptor agonist intervention search). Each cohort has its own matched placebo and duration, so one comparison per cohort.", "decided_by": "both_coders" }, { "nct": "NCT02597049", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "dulaglutide" ], "background": "SGLT2 inhibitor with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "AWARD-10.", "decided_by": "both_coders" }, { "nct": "NCT02607306", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "Japanese adults with type 2 diabetes.", "note": "Open-label IDegLira vs insulin degludec vs liraglutide on OADs; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02607865", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "PIONEER 3: double-dummy oral semaglutide vs sitagliptin.", "decided_by": "both_coders" }, { "nct": "NCT02635386", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "other", "population_note": "Women with polycystic ovary syndrome and obesity.", "note": "Single-blind comparison of exenatide QW, dapagliflozin, exenatide + dapagliflozin, dapagliflozin/metformin ER and phentermine/topiramate ER; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02647944", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "Adults with obesity; diabetes status not stated.", "note": "Liraglutide 3.0 mg (Saxenda).", "decided_by": "both_coders" }, { "nct": "NCT02648204", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "SUSTAIN 7: open-label semaglutide vs dulaglutide on metformin; both GLP-1 receptor agonists, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02664441", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "none" } ], "population": "other", "population_note": "Hypothalamic obesity after craniopharyngioma or other hypothalamic tumours; diabetes status not stated.", "note": "36-week double-blind groups only; EG002 is the 18-week open-label exenatide extension, left out.", "decided_by": "third_reader" }, { "nct": "NCT02683746", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Both groups get albiglutide (two formulations, each with the other's matching placebo); no placebo-only group.", "decided_by": "both_coders" }, { "nct": "NCT02692716", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "standard of care" } ], "population": "type2_diabetes", "population_note": "", "note": "Oral semaglutide CV outcomes trial; AE collection limited to SAEs and selected AEs.", "decided_by": "both_coders" }, { "nct": "NCT02730377", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label liraglutide vs investigator-chosen oral antidiabetic drug, both on metformin.", "decided_by": "both_coders" }, { "nct": "NCT02750410", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "dulaglutide" ], "background": "insulin with or without oral antidiabetic drugs" } ], "population": "type2_diabetes", "population_note": "", "note": "Uses the 16-week double-blind period groups; EG002 and EG003 span the open-label extension (placebo group switched to dulaglutide) and are excluded.", "decided_by": "both_coders" }, { "nct": "NCT02759107", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005", "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none (healthy volunteers, Part A)" }, { "glp1_groups": [ "EG008", "EG009", "EG010", "EG011", "EG012" ], "placebo_groups": [ "EG007" ], "molecules": [ "tirzepatide", "dulaglutide" ], "background": "none (healthy volunteers, Part B)" }, { "glp1_groups": [ "EG014", "EG015", "EG016", "EG017" ], "placebo_groups": [ "EG013" ], "molecules": [ "tirzepatide" ], "background": "none (type 2 diabetes, Part C)" } ], "population": "mixed", "population_note": "Healthy volunteers in Parts A and B, type 2 diabetes in Part C.", "note": "One comparison per part, each part with its own placebo. Part A arms say single doses while its AE group texts say weekly for four weeks. Part B dulaglutide (labelled active comparator) included as a GLP-1 group against the double-blind placebo injection; drop EG008 if dulaglutide was unblinded.", "decided_by": "both_coders" }, { "nct": "NCT02765399", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "", "note": "Single-blind placebo injection.", "decided_by": "both_coders" }, { "nct": "NCT02773368", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label IDegLira (degludec/liraglutide) vs insulin glargine, both on SGLT2i; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02777073", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "liraglutide" ], "background": "usual insulin (not stated)" } ], "population": "type1_diabetes", "population_note": "", "note": "Single doses, single-blind. Dapagliflozin group EG001 excluded.", "decided_by": "both_coders" }, { "nct": "NCT02787551", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label glargine/lixisenatide FRC vs continued GLP-1 RA; every arm gets a GLP-1 RA; EG002 is the extension.", "decided_by": "both_coders" }, { "nct": "NCT02793154", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Part A single-arm exenatide; Part B (albiglutide vs exenatide, open-label) enrolled no one. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT02827708", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "background glucose-lowering therapy (not specified)" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with moderate renal impairment.", "note": "Oral semaglutide.", "decided_by": "both_coders" }, { "nct": "NCT02846233", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label: albiglutide or dulaglutide plus empagliflozin (replacing prandial insulin) vs unchanged usual care; also combined with another active drug.", "decided_by": "both_coders" }, { "nct": "NCT02849080", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label oral semaglutide vs sitagliptin; extension groups too.", "decided_by": "both_coders" }, { "nct": "NCT02863328", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label oral semaglutide vs empagliflozin.", "decided_by": "both_coders" }, { "nct": "NCT02863419", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide", "liraglutide" ], "background": "metformin with or without SGLT2 inhibitor" } ], "population": "type2_diabetes", "population_note": "", "note": "Double-dummy: placebo group got both oral semaglutide placebo and liraglutide placebo, so both GLP-1 groups compare against it.", "decided_by": "both_coders" }, { "nct": "NCT02906930", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "semaglutide" ], "background": "diet and exercise" } ], "population": "type2_diabetes", "population_note": "", "note": "Oral semaglutide monotherapy.", "decided_by": "both_coders" }, { "nct": "NCT02911818", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Main trial open-label: lifestyle counselling alone vs with liraglutide, no placebo. The extension randomizes phentermine vs placebo on liraglutide (GLP-1 is background there).", "decided_by": "both_coders" }, { "nct": "NCT02911948", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Double-blind IDegLira vs insulin degludec, both titrated, on metformin: comparator is active insulin, not a liraglutide placebo.", "decided_by": "both_coders" }, { "nct": "NCT02918279", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "overweight_obesity", "population_note": "Pubertal adolescents with obesity.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02953665", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "other", "population_note": "Parkinson's disease.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02960659", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "African-American youth.", "note": "Open-label metformin vs metformin plus liraglutide; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02962492", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "exenatide" ], "background": "insulin (type 1 diabetes) with dapagliflozin placebo" }, { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "dapagliflozin" } ], "population": "type1_diabetes", "population_note": "", "note": "2x2 factorial with matching placebos for both drugs. Exenatide 5 ug acutely, then exenatide extended release for 12 weeks. AE monitoring limited to severe hypoglycaemia and DKA.", "decided_by": "both_coders" }, { "nct": "NCT02963766", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "dulaglutide" ], "background": "background diabetes therapy (not specified)" } ], "population": "type2_diabetes", "population_note": "Children and adolescents with type 2 diabetes.", "note": "Double-blind period groups only; open-label extension groups EG003-EG005 excluded.", "decided_by": "both_coders" }, { "nct": "NCT02963922", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "basal insulin" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "Liraglutide 3.0 mg.", "decided_by": "both_coders" }, { "nct": "NCT02963935", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "intensive behavioural therapy" } ], "population": "overweight_obesity", "population_note": "", "note": "Liraglutide 3.0 mg.", "decided_by": "both_coders" }, { "nct": "NCT02964247", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "SGLT2 inhibitor with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02970942", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "semaglutide" ], "background": "none stated" } ], "population": "other", "population_note": "Non-alcoholic steatohepatitis (diabetes not required).", "note": "Three placebo arms reported pooled as EG003.", "decided_by": "both_coders" }, { "nct": "NCT02973100", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "dulaglutide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "Dulaglutide 1.5 mg arm is labelled active comparator but is a GLP-1 group against placebo.", "decided_by": "both_coders" }, { "nct": "NCT02973321", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG005" ], "placebo_groups": [ "EG000" ], "molecules": [ "liraglutide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "SAR425899 is not on the list and the record doesn't describe it as a GLP-1 receptor agonist, so EG001-EG004 (which are also grouped by dose received at week 8) are left out. Liraglutide (labelled active comparator) vs the SAR425899 placebo, both daily SC on metformin for 26 weeks, quadruple-masked; the liraglutide arm lists no SAR425899 placebo.", "decided_by": "third_reader" }, { "nct": "NCT02975297", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "nicotine patch and smoking cessation counselling" } ], "population": "other", "population_note": "Adults who smoke, seeking to quit.", "note": "Exenatide once weekly.", "decided_by": "both_coders" }, { "nct": "NCT02981069", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG003" ], "molecules": [ "exenatide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "", "note": "Factorial exenatide x dapagliflozin. Masking listed as NONE though a placebo arm exists; what the placebo mimicked is not stated. EG002 vs EG001 not used: dapagliflozin arm got no exenatide placebo.", "decided_by": "both_coders" }, { "nct": "NCT03010683", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "mixed", "population_note": "Coronary artery disease patients and type 2 diabetes patients.", "note": "Liraglutide vs metformin.", "decided_by": "both_coders" }, { "nct": "NCT03015220", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label oral semaglutide vs dulaglutide; every arm gets a GLP-1 RA.", "decided_by": "both_coders" }, { "nct": "NCT03018028", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG004" ], "molecules": [ "semaglutide" ], "background": "none (monotherapy)" } ], "population": "type2_diabetes", "population_note": "", "note": "Placebo tablets match oral semaglutide only; liraglutide 0.9 mg injection (EG003) had no matching placebo and is excluded.", "decided_by": "both_coders" }, { "nct": "NCT03021187", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "semaglutide" ], "background": "insulin" } ], "population": "type2_diabetes", "population_note": "", "note": "Oral semaglutide.", "decided_by": "both_coders" }, { "nct": "NCT03029351", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with micro- or macroalbuminuria.", "note": "Exenatide extended release.", "decided_by": "both_coders" }, { "nct": "NCT03036800", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "mixed", "population_note": "Obesity service patients, with or without diabetes (diabetes listed among conditions).", "note": "Open-label liraglutide 3.0 mg plus standard care vs standard care.", "decided_by": "both_coders" }, { "nct": "NCT03038620", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "overweight_obesity", "population_note": "At high cardiovascular risk.", "note": "Placebo described as a 'tablet' but given by SC injection matching liraglutide.", "decided_by": "both_coders" }, { "nct": "NCT03041792", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "Saline placebo injection.", "decided_by": "both_coders" }, { "nct": "NCT03048578", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "prior Roux-en-Y gastric bypass" } ], "population": "overweight_obesity", "population_note": "Weight regain after Roux-en-Y gastric bypass.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03061214", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Double-dummy semaglutide vs sitagliptin.", "decided_by": "both_coders" }, { "nct": "NCT03086330", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "SGLT2 inhibitor" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03101930", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "overweight_obesity", "population_note": "Obesity with prediabetes.", "note": "Liraglutide vs sitagliptin (double-dummy) vs hypocaloric diet; no group gets placebo alone.", "decided_by": "both_coders" }, { "nct": "NCT03115424", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "sleeve gastrectomy 3 months earlier" } ], "population": "overweight_obesity", "population_note": "After sleeve gastrectomy.", "note": "RYGB group EG002 was not randomized and is excluded.", "decided_by": "both_coders" }, { "nct": "NCT03131687", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide", "dulaglutide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "", "note": "Double-dummy: placebo group got both tirzepatide and dulaglutide placebos.", "decided_by": "both_coders" }, { "nct": "NCT03136484", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Double-dummy semaglutide vs canagliflozin on metformin.", "decided_by": "both_coders" }, { "nct": "NCT03151005", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "other", "population_note": "Overweight women with polycystic ovary syndrome.", "note": "Metformin plus exenatide or liraglutide vs metformin plus oral contraceptive.", "decided_by": "both_coders" }, { "nct": "NCT03158805", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "bipolar disorder medications" } ], "population": "other", "population_note": "Overweight or obesity with stable bipolar disorder.", "note": "Liraglutide 3 mg.", "decided_by": "both_coders" }, { "nct": "NCT03172494", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label IDegLira vs insulin degludec vs liraglutide; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03175120", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Double-blind IDegLira vs insulin degludec on metformin: comparator is active insulin, not a liraglutide placebo.", "decided_by": "both_coders" }, { "nct": "NCT03191396", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label semaglutide vs liraglutide.", "decided_by": "both_coders" }, { "nct": "NCT03235050", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG002", "EG003", "EG004" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "MEDI0382 is cotadutide. Liraglutide EG001 was open-label with no matching placebo and is excluded.", "decided_by": "both_coders" }, { "nct": "NCT03244800", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "none stated (cohort 1)" }, { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "cotadutide" ], "background": "none stated (cohort 2)" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "MEDI0382 is cotadutide. One comparison per cohort, each with its own placebo; they could be pooled.", "decided_by": "both_coders" }, { "nct": "NCT03260881", "eligible": false, "exclusion_reason": "background_differs", "comparisons": [], "population": "type2_diabetes", "population_note": "Type 2 diabetes with coronary artery disease awaiting CABG.", "note": "Placebo (D-group) arm also started a supervised low-calorie diet that the liraglutide arm did not get.", "decided_by": "both_coders" }, { "nct": "NCT03279731", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "other", "population_note": "Binge-eating disorder.", "note": "Liraglutide 3.0 mg.", "decided_by": "both_coders" }, { "nct": "NCT03311724", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03322631", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "Japanese patients.", "note": "Multiple-ascending-dose cohorts share one pooled placebo group.", "decided_by": "both_coders" }, { "nct": "NCT03353350", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "efpeglenatide" ], "background": "diet and exercise" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03374956", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Phenotype-guided vs randomly assigned anti-obesity drug; both groups mix several drugs; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03375463", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "population": "other", "population_note": "Healthy volunteers.", "note": "Only Part C has a placebo (EG003), and its tirzepatide AE groups EG004-EG007 split the same participants by dosing day; Parts A, B, D have no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03434119", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label glargine/lixisenatide vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT03444584", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "metformin and dapagliflozin" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "MEDI0382 is cotadutide.", "decided_by": "both_coders" }, { "nct": "NCT03480022", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "other", "population_note": "Women with obesity and polycystic ovary syndrome (prediabetes listed).", "note": "Liraglutide 3 mg.", "decided_by": "both_coders" }, { "nct": "NCT03482024", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "other", "population_note": "Renal impairment of varying severity and healthy controls.", "note": "Open-label single-dose PK study; every group gets tirzepatide.", "decided_by": "both_coders" }, { "nct": "NCT03486392", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "efinopegdutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "Severe obesity without diabetes.", "note": "JNJ-64565111 is efinopegdutide (GLP-1/glucagon co-agonist). Open-label liraglutide EG004 has no matching placebo and is excluded.", "decided_by": "both_coders" }, { "nct": "NCT03495102", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Three dulaglutide doses, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03496298", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "efpeglenatide" ], "background": "standard of care (not specified)" } ], "population": "type2_diabetes", "population_note": "High cardiovascular risk.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03500484", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "Youth with obesity; lean comparison group.", "note": "All participants with obesity get liraglutide; lean group is a non-randomized no-intervention comparison.", "decided_by": "both_coders" }, { "nct": "NCT03523273", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "overweight_obesity", "population_note": "", "note": "Liraglutide 3.0 mg.", "decided_by": "both_coders" }, { "nct": "NCT03548935", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none stated" } ], "population": "overweight_obesity", "population_note": "", "note": "Semaglutide 2.4 mg.", "decided_by": "both_coders" }, { "nct": "NCT03548987", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "20-week semaglutide run-in; reduced-calorie diet and physical activity" } ], "population": "overweight_obesity", "population_note": "", "note": "Randomized withdrawal at week 20 after open run-in; EG000 (run-in) excluded. AEs counted from randomized treatment.", "decided_by": "both_coders" }, { "nct": "NCT03550378", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with renal impairment.", "note": "MEDI0382 is cotadutide.", "decided_by": "both_coders" }, { "nct": "NCT03552757", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "Double-dummy placebos for both doses.", "decided_by": "both_coders" }, { "nct": "NCT03555994", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "none stated (Part A)" }, { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG004" ], "molecules": [ "cotadutide" ], "background": "none stated (Part B)" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "MEDI0382 is cotadutide. One comparison per part. Liraglutide EG002 (Part B) was open-label with no matching placebo and is excluded.", "decided_by": "both_coders" }, { "nct": "NCT03574597", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "standard of care" } ], "population": "overweight_obesity", "population_note": "Overweight or obesity with established cardiovascular disease.", "note": "Not all AEs collected systematically.", "decided_by": "both_coders" }, { "nct": "NCT03596177", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "MEDI0382 is cotadutide. Both arms had a 16-day placebo lead-in; AEs reported from the double-blind period.", "decided_by": "both_coders" }, { "nct": "NCT03596450", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label pragmatic semaglutide vs standard of care.", "decided_by": "both_coders" }, { "nct": "NCT03611582", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "intensive behavioural therapy" } ], "population": "overweight_obesity", "population_note": "", "note": "Semaglutide 2.4 mg.", "decided_by": "both_coders" }, { "nct": "NCT03645421", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "diet and exercise" } ], "population": "type2_diabetes", "population_note": "Japanese patients with type 2 diabetes and pre-obesity or obesity.", "note": "MEDI0382 is cotadutide.", "decided_by": "both_coders" }, { "nct": "NCT03684642", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label efpeglenatide vs dulaglutide on metformin.", "decided_by": "both_coders" }, { "nct": "NCT03689374", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label semaglutide vs insulin aspart on metformin and glargine.", "decided_by": "both_coders" }, { "nct": "NCT03693430", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "", "note": "Semaglutide 2.4 mg, 104 weeks.", "decided_by": "both_coders" }, { "nct": "NCT03712098", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "smoking cessation counselling" } ], "population": "other", "population_note": "Adults who smoke (nicotine dependence).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03713684", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "efpeglenatide" ], "background": "basal insulin with or without oral antidiabetic drugs" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03730662", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label tirzepatide vs insulin glargine.", "decided_by": "both_coders" }, { "nct": "NCT03737240", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label IDegLira vs basal-bolus insulin.", "decided_by": "both_coders" }, { "nct": "NCT03743025", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dulaglutide" ], "background": "cardiac surgery" } ], "population": "other", "population_note": "Cardiac surgery patients without diabetes.", "note": "Single dose before surgery; saline placebo injection though masking listed as NONE. Only selected AEs collected.", "decided_by": "both_coders" }, { "nct": "NCT03745937", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "cotadutide" ], "background": "none stated (cohort 1)" }, { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "cotadutide" ], "background": "none stated (cohort 2)" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with overweight or obesity.", "note": "MEDI0382 is cotadutide. One comparison per cohort, each with its own placebo; they could be pooled.", "decided_by": "both_coders" }, { "nct": "NCT03770728", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "efpeglenatide" ], "background": "metformin with or without sulfonylurea" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03799198", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Open-label weight programme plus one of five drugs (liraglutide among them) vs programme alone; drug group mixes exposures.", "decided_by": "both_coders" }, { "nct": "NCT03811574", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "none stated" } ], "population": "overweight_obesity", "population_note": "East Asian adults.", "note": "Two placebo arms (matching 1.7 and 2.4 mg) reported pooled as EG002.", "decided_by": "both_coders" }, { "nct": "NCT03819153", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "standard of care" } ], "population": "type2_diabetes", "population_note": "Type 2 diabetes with chronic kidney disease.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03856047", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG005" ], "placebo_groups": [ "EG006" ], "molecules": [ "liraglutide" ], "background": "none stated" } ], "population": "overweight_obesity", "population_note": "", "note": "NNC0174-0833 is cagrilintide (amylin analogue), not a GLP-1 RA: EG000-EG004 excluded. Liraglutide had its own blinded placebo arm, but the AE placebo group EG006 pools it with the cagrilintide placebos (weekly vs daily injections).", "decided_by": "both_coders" }, { "nct": "NCT03861039", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label tirzepatide doses on oral antihyperglycaemic monotherapy; no comparator.", "decided_by": "both_coders" }, { "nct": "NCT03861052", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Tirzepatide vs dulaglutide; every arm gets a GLP-1 RA.", "decided_by": "both_coders" }, { "nct": "NCT03882970", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label tirzepatide vs insulin degludec.", "decided_by": "both_coders" }, { "nct": "NCT03914326", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "", "note": "Oral semaglutide CV outcomes trial.", "decided_by": "both_coders" }, { "nct": "NCT03919929", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "other", "population_note": "Adolescents with polycystic ovary syndrome, obesity and NAFLD.", "note": "Open-label oral semaglutide vs diet.", "decided_by": "both_coders" }, { "nct": "NCT03951753", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "semaglutide", "tirzepatide" ], "background": "none stated" } ], "population": "type2_diabetes", "population_note": "", "note": "Double-blind, all weekly SC; semaglutide 1 mg labelled active comparator but counted as a GLP-1 group against placebo.", "decided_by": "both_coders" }, { "nct": "NCT03954834", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "tirzepatide" ], "background": "diet and exercise" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03985293", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005" ], "placebo_groups": [ "EG000" ], "molecules": [ "danuglipron" ], "background": "metformin or diet and exercise" } ], "population": "type2_diabetes", "population_note": "", "note": "PF-06882961 is danuglipron.", "decided_by": "both_coders" }, { "nct": "NCT03987074", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "other", "population_note": "Non-alcoholic steatohepatitis.", "note": "Open-label semaglutide alone or with firsocostat and/or cilofexor; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03987451", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none stated" } ], "population": "other", "population_note": "NASH with compensated cirrhosis.", "note": "Semaglutide 2.4 mg.", "decided_by": "both_coders" }, { "nct": "NCT03987919", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label tirzepatide vs semaglutide on metformin.", "decided_by": "both_coders" }, { "nct": "NCT03989232", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Semaglutide 2.0 vs 1.0 mg.", "decided_by": "both_coders" }, { "nct": "NCT04017832", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Double-dummy oral semaglutide vs sitagliptin on metformin.", "decided_by": "both_coders" }, { "nct": "NCT04019197", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none stated" } ], "population": "other", "population_note": "HIV-associated lipohypertrophy.", "note": "Groups include 24 weeks off drug after 32 weeks of treatment, the same in both arms.", "decided_by": "both_coders" }, { "nct": "NCT04019561", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "cotadutide" ], "background": "none stated" } ], "population": "other", "population_note": "Obesity with NAFLD/NASH (diabetes not required).", "note": "MEDI0382 is cotadutide. One participant randomized to 600 ug received 300 ug (as-treated groups).", "decided_by": "both_coders" }, { "nct": "NCT04039503", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "tirzepatide" ], "background": "insulin glargine with or without metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04074161", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide", "liraglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "", "note": "Pooled placebo combines semaglutide-matched and liraglutide-matched placebo; liraglutide arm is labeled active comparator but had its own matched placebo, so both GLP-1 groups are compared with the pooled placebo.", "decided_by": "both_coders" }, { "nct": "NCT04081337", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04093752", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label tirzepatide vs titrated insulin glargine on metformin with or without sulfonylurea; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04102189", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "adolescents", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04109547", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "semaglutide" ], "background": "diet and exercise" } ], "population": "type2_diabetes", "population_note": "", "note": "Oral semaglutide.", "decided_by": "both_coders" }, { "nct": "NCT04126603", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "Arm labeled active comparator is semaglutide against placebo injection; background therapy not stated.", "decided_by": "both_coders" }, { "nct": "NCT04153929", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005", "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "survodutide" ], "background": "metformin" } ], "population": "type2_diabetes", "population_note": "", "note": "BI 456906 is survodutide. Semaglutide group (EG007) was open-label with no matched placebo, so left out; placebo pools once- and twice-weekly BI 456906 placebo.", "decided_by": "both_coders" }, { "nct": "NCT04166773", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "other", "population_note": "nonalcoholic steatohepatitis", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04184622", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "obesity or overweight without type 2 diabetes, normoglycemia or prediabetes", "note": "Groups include the extended period to week 176 for participants with prediabetes, still as randomized.", "decided_by": "both_coders" }, { "nct": "NCT04199728", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "liraglutide" ], "background": "opioid use disorder treatment" } ], "population": "other", "population_note": "opioid use disorder", "note": "Background is the participants' opioid treatment setting, the same in both arms.", "decided_by": "both_coders" }, { "nct": "NCT04235959", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "Two titration cohorts against one placebo group.", "decided_by": "both_coders" }, { "nct": "NCT04251156", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "mixed", "population_note": "overweight or obesity with or without type 2 diabetes (type 2 diabetes among listed conditions)", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04255433", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Tirzepatide vs dulaglutide 1.5 mg; no placebo group.", "decided_by": "both_coders" }, { "nct": "NCT04311411", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide", "liraglutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "Liraglutide (labelled active comparator; daily SC escalating to 3 mg, about 5.5 weeks of dosing) pooled with tirzepatide against the SC placebo of this double-blind trial; the record doesn't say liraglutide was open-label or what the placebo matched. AE groups are by regimen received.", "decided_by": "third_reader" }, { "nct": "NCT04431713", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "other", "population_note": "multiple system atrophy", "note": "Open-label exenatide vs standard of care, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04515576", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "dulaglutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "Dulaglutide 1.5 mg QW (labeled active comparator) vs placebo SC QW in a double-blind design. LY3493269 groups (EG002-EG005) left out: the record doesn't describe its mechanism (possibly an incretin co-agonist); include them if it is a GLP-1 RA.", "decided_by": "both_coders" }, { "nct": "NCT04515849", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "cotadutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes with chronic kidney disease", "note": "Semaglutide group (EG004) was an open-label comparator, so left out.", "decided_by": "both_coders" }, { "nct": "NCT04531176", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "type 2 diabetes with obesity", "note": "Open-label pragmatic trial; the medication arm chooses among orlistat, phentermine/topiramate, naltrexone/bupropion, or liraglutide; controls are weight management or usual care, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04537923", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label tirzepatide vs insulin lispro on insulin glargine with or without metformin.", "decided_by": "both_coders" }, { "nct": "NCT04538352", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label semaglutide plus basal insulin vs basal-bolus insulin (prandial insulin as comparator); no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04552470", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "danuglipron" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "PF-06882961 is danuglipron.", "decided_by": "both_coders" }, { "nct": "NCT04560998", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "standard-of-care treatment" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes with peripheral arterial disease", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04591626", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dulaglutide" ], "background": "titrated insulin glargine with metformin and/or acarbose" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04596631", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "metformin and/or basal insulin with diet and exercise" } ], "population": "type2_diabetes", "population_note": "children and adolescents", "note": "Oral semaglutide.", "decided_by": "both_coders" }, { "nct": "NCT04616027", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "mixed", "population_note": "type 2 diabetes with varying renal function, and healthy participants", "note": "Open-label single-dose PK study of PF-06882961 (danuglipron); groups by renal function, not randomized against placebo; EG005 is a total.", "decided_by": "both_coders" }, { "nct": "NCT04617275", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG002", "EG003", "EG004", "EG005", "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "danuglipron" ], "background": "metformin" }, { "glp1_groups": [ "EG007" ], "placebo_groups": [ "EG001" ], "molecules": [ "danuglipron" ], "background": "none" } ], "population": "mixed", "population_note": "separate cohorts: type 2 diabetes on metformin, and non-diabetic obesity", "note": "PF-06882961 is danuglipron. One comparison per cohort, each with its own placebo group.", "decided_by": "both_coders" }, { "nct": "NCT04624672", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "semaglutide" ], "background": "planned Roux-en-Y gastric bypass after 4-6 months" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes awaiting bariatric surgery", "note": "Single-blind; arm labeled active comparator is semaglutide against placebo injection.", "decided_by": "both_coders" }, { "nct": "NCT04657003", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes with overweight or obesity", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04657016", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "after an intensive lifestyle program lead-in" } ], "population": "overweight_obesity", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04660643", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "tirzepatide" ], "background": "after 36-week open-label tirzepatide lead-in" } ], "population": "overweight_obesity", "population_note": "", "note": "Randomized withdrawal: EG000 is the open-label tirzepatide lead-in (all participants), left out; EG002 continued tirzepatide vs EG001 switched to placebo.", "decided_by": "both_coders" }, { "nct": "NCT04667377", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG004" ], "molecules": [ "survodutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "BI 456906 is survodutide; groups by actual maintenance dose.", "decided_by": "both_coders" }, { "nct": "NCT04707313", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005", "EG006", "EG007", "EG008" ], "placebo_groups": [ "EG000" ], "molecules": [ "danuglipron" ], "background": "none" }, { "glp1_groups": [ "EG010", "EG011", "EG012" ], "placebo_groups": [ "EG009" ], "molecules": [ "danuglipron" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "PF-06882961 is danuglipron. Cohorts 1-2 (26 weeks) and cohort 3 (32 weeks) each have their own placebo, so one comparison per cohort set.", "decided_by": "both_coders" }, { "nct": "NCT04707469", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Oral semaglutide 25 and 50 mg vs 14 mg; dose comparison only.", "decided_by": "both_coders" }, { "nct": "NCT04741074", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "mixed", "population_note": "Obesity with stage 4-5 CKD or dialysis-dependent ESKD, with or without type 2 diabetes (diabetic kidney disease and type 2 diabetes listed alongside obesity and CKD).", "note": "Semaglutide arm labelled active comparator; placebo matched, with the same escalation instructions.", "decided_by": "third_reader" }, { "nct": "NCT04771273", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "survodutide" ], "background": "none" } ], "population": "other", "population_note": "nonalcoholic steatohepatitis with fibrosis", "note": "Groups by actual maintenance dose; placebo matched to survodutide.", "decided_by": "both_coders" }, { "nct": "NCT04779697", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04788511", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "standard of care" } ], "population": "other", "population_note": "obesity-related heart failure with preserved ejection fraction", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04809220", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Dulaglutide 1.5 mg vs 0.75 mg; dose comparison only.", "decided_by": "both_coders" }, { "nct": "NCT04844918", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "obesity disease", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04847557", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "other", "population_note": "heart failure with preserved ejection fraction and obesity", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04862234", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dulaglutide" ], "background": "planned general or vascular surgery" } ], "population": "other", "population_note": "surgical patients at risk of perioperative stress hyperglycemia", "note": "Single dose within 72 hours before surgery; diabetes status of the population not stated.", "decided_by": "both_coders" }, { "nct": "NCT04865770", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes with chronic kidney disease", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04867785", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005", "EG006", "EG007" ], "placebo_groups": [ "EG000" ], "molecules": [ "retatrutide", "dulaglutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "LY3437943 is retatrutide. Dulaglutide (labelled active comparator) included: weekly SC like the placebo in a double-blind trial, and the record doesn't describe it as open-label or the placebo as matching LY3437943 only.", "decided_by": "third_reader" }, { "nct": "NCT04881110", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "type 2 diabetes with peripheral artery disease", "note": "Liraglutide vs monitored risk-factor control without placebo.", "decided_by": "both_coders" }, { "nct": "NCT04881760", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005", "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "retatrutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "LY3437943 is retatrutide.", "decided_by": "both_coders" }, { "nct": "NCT04889157", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "danuglipron" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "PF-06882961 is danuglipron.", "decided_by": "both_coders" }, { "nct": "NCT04944992", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "other", "population_note": "nonalcoholic fatty liver disease", "note": "Open-label efinopegdutide vs semaglutide; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04969939", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Semaglutide 2.4 mg in every arm; trial tests NNC0165-1875 vs placebo; EG003 is a semaglutide run-in.", "decided_by": "both_coders" }, { "nct": "NCT04971785", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "semaglutide" ], "background": "placebo-to-match cilofexor/firsocostat" }, { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "cilofexor/firsocostat fixed-dose combination" } ], "population": "other", "population_note": "compensated cirrhosis due to NASH", "note": "2x2 factorial double-dummy: semaglutide vs matching placebo within each cilofexor/firsocostat stratum.", "decided_by": "both_coders" }, { "nct": "NCT04982575", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "cagrilintide 2.4 mg" } ], "population": "type2_diabetes", "population_note": "", "note": "Cagrilintide + semaglutide vs cagrilintide + semaglutide placebo differ only in semaglutide. EG002 (semaglutide + cagrilintide placebo) has no matching double-placebo group, so left out.", "decided_by": "both_coders" }, { "nct": "NCT04998136", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05024032", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05035082", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label pragmatic oral semaglutide vs other oral glucose-lowering drugs on metformin.", "decided_by": "both_coders" }, { "nct": "NCT05035095", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "Oral semaglutide 50 mg.", "decided_by": "both_coders" }, { "nct": "NCT05040971", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "obesity with prediabetes", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05048719", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003", "EG004", "EG005", "EG006", "EG007", "EG008" ], "placebo_groups": [ "EG000" ], "molecules": [ "orforglipron", "dulaglutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "LY3502970 is orforglipron. Dulaglutide (labelled active comparator; SC weekly, while LY3502970 is oral daily) included against the 'matching placebo' of this double-blind trial; the record doesn't say what the placebo matched or that dulaglutide was open-label.", "decided_by": "third_reader" }, { "nct": "NCT05051579", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002", "EG003", "EG004", "EG005" ], "placebo_groups": [ "EG006" ], "molecules": [ "orforglipron" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "LY3502970 is orforglipron.", "decided_by": "both_coders" }, { "nct": "NCT05056246", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "other", "population_note": "healthy Japanese and Caucasian volunteers", "note": "AMG 133 is maridebart cafraglutide; open-label single-dose study with dose groups only, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05064735", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "other", "population_note": "knee osteoarthritis with obesity", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05086445", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "orforglipron" ], "background": "none" }, { "glp1_groups": [ "EG004", "EG005", "EG006" ], "placebo_groups": [ "EG003" ], "molecules": [ "orforglipron" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "LY3502970 is orforglipron. Part A single dose and Part B 12-week multiple dose, each with its own placebo; Part B groups include Part A completers continuing on the same assignment, so the two comparisons share some participants.", "decided_by": "both_coders" }, { "nct": "NCT05132088", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "East Asian adults with overweight or obesity", "note": "Oral semaglutide 50 mg.", "decided_by": "both_coders" }, { "nct": "NCT05144984", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG004" ], "placebo_groups": [ "EG006" ], "molecules": [ "semaglutide" ], "background": "placebo for NNC0480-0389" }, { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG005" ], "molecules": [ "semaglutide" ], "background": "NNC0480-0389 21.6 mg" } ], "population": "type2_diabetes", "population_note": "", "note": "Semaglutide + NNC0480-0389 placebo vs double placebo; and semaglutide + NNC0480-0389 21.6 mg vs NNC0480-0389 21.6 mg + semaglutide placebo. EG000-EG002 (semaglutide with lower NNC0480-0389 doses) have no matching comparator, left out. NNC0480-0389 not described as a GLP-1 RA.", "decided_by": "both_coders" }, { "nct": "NCT05259033", "eligible": false, "exclusion_reason": "glp1_is_background", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label IcoSema (insulin icodec + semaglutide) vs semaglutide: semaglutide in both arms, testing insulin icodec; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05260021", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "tirzepatide" ], "background": "metformin and/or basal insulin" } ], "population": "type2_diabetes", "population_note": "children and adolescents", "note": "Double-blind 30-week period only; open-label extension groups EG003-EG005 left out (placebo switched to tirzepatide).", "decided_by": "both_coders" }, { "nct": "NCT05302596", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "older adults with obesity", "note": "Open-label semaglutide plus standard-of-care weight loss vs standard of care alone.", "decided_by": "both_coders" }, { "nct": "NCT05313802", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "healthy adults with overweight or obesity", "note": "LY3502970 is orforglipron; adverse events reported only for three orforglipron titration cohorts, no placebo group.", "decided_by": "both_coders" }, { "nct": "NCT05347147", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "exenatide" ], "background": "none" } ], "population": "other", "population_note": "idiopathic intracranial hypertension", "note": "Presendin is exenatide (placebo described as lacking exenatide acetate). EG002 is all subjects before treatment, left out.", "decided_by": "both_coders" }, { "nct": "NCT05352815", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label IcoSema (insulin icodec + semaglutide) vs insulin icodec alone; differs by semaglutide but has no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05364931", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002", "EG003" ], "molecules": [ "cotadutide" ], "background": "none" } ], "population": "other", "population_note": "Non-cirrhotic NASH with fibrosis.", "note": "Each cotadutide dose has a volume-matched placebo group; placebo volume is not a different background, so doses and placebos are pooled. Group descriptions are placeholders; identities from titles.", "decided_by": "third_reader" }, { "nct": "NCT05412004", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "tirzepatide" ], "background": "not on positive airway pressure therapy" }, { "glp1_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "tirzepatide" ], "background": "positive airway pressure therapy" } ], "population": "other", "population_note": "obstructive sleep apnea with obesity", "note": "Master protocol with two studies by PAP use, each with its own placebo.", "decided_by": "both_coders" }, { "nct": "NCT05413369", "eligible": false, "exclusion_reason": "glp1_combined_with_other_active", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label iGlarLixi (insulin glargine + lixisenatide fixed ratio) vs IDegAsp; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05478252", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Two semaglutide drug products (J vs B) on metformin; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05486065", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes with overweight", "note": "Placebo pools volume-matched placebos for the three semaglutide doses.", "decided_by": "both_coders" }, { "nct": "NCT05514535", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "type 2 diabetes with overweight", "note": "Open-label semaglutide plus dose-reduced insulin glargine vs titrated insulin glargine; no placebo and insulin dosing differs.", "decided_by": "both_coders" }, { "nct": "NCT05520775", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "other", "population_note": "alcohol use disorder (with cigarette smoking)", "note": "Comparator is a sham/placebo subcutaneous injection under triple masking, counted as placebo.", "decided_by": "both_coders" }, { "nct": "NCT05530577", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "other", "population_note": "tobacco use disorder", "note": "Comparator is a sham/placebo subcutaneous injection under triple masking, counted as placebo.", "decided_by": "both_coders" }, { "nct": "NCT05537233", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "hybrid closed-loop insulin therapy" } ], "population": "type1_diabetes", "population_note": "type 1 diabetes with obesity", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05548647", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "semaglutide" ], "background": "behavioral weight-loss treatment" }, { "glp1_groups": [ "EG004" ], "placebo_groups": [ "EG003" ], "molecules": [ "semaglutide" ], "background": "behavioral treatment, after 60 weeks of semaglutide" } ], "population": "overweight_obesity", "population_note": "", "note": "Weeks 0-60: semaglutide vs placebo. Weeks 60-72: semaglutide-treated participants re-randomized to continue semaglutide (EG004) or switch to placebo (EG003), a randomized withdrawal; EG002 (continuing placebo) has a different prior exposure, left out. The two comparisons cover different periods of overlapping participants.", "decided_by": "both_coders" }, { "nct": "NCT05564039", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label tirzepatide vs high-dose dulaglutide; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05564117", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "Oral semaglutide 25 mg.", "decided_by": "both_coders" }, { "nct": "NCT05579249", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Open-label pragmatic semaglutide 2.4 mg vs physician-chosen anti-obesity drugs (orlistat, phentermine/topiramate, naltrexone/bupropion, or liraglutide); no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05579977", "eligible": false, "exclusion_reason": "other", "comparisons": [], "population": "mixed", "population_note": "separate cohorts: type 2 diabetes on metformin, and obesity without type 2 diabetes", "note": "PF-07081532 (lotiglipron) is not on the codebook list and the record doesn't describe its mechanism, so its groups aren't counted as GLP-1 groups; oral semaglutide (EG006) was open-label with no placebo for it. If PF-07081532 is accepted as a GLP-1 RA: EG001-EG005 vs EG000 (T2D, metformin) and EG008-EG012 vs EG007 (obesity).", "decided_by": "both_coders" }, { "nct": "NCT05616013", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Semaglutide was open-label with no placebo injection; bimagrumab is the blinded drug. EG000 also switched from IV placebo to bimagrumab at week 52.", "decided_by": "both_coders" }, { "nct": "NCT05646706", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05649137", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "semaglutide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes with obesity", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05691712", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "tirzepatide" ], "background": "titrated basal insulin" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05696847", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "tirzepatide" ], "background": "none" }, { "glp1_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "tirzepatide" ], "background": "none" }, { "glp1_groups": [ "EG005" ], "placebo_groups": [ "EG004" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "children aged 6 to 11 with obesity", "note": "Three body-weight cohorts, each with its own placebo; one comparison per cohort.", "decided_by": "both_coders" }, { "nct": "NCT05786521", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "mixed", "population_note": "older adults with overweight or obesity and insulin resistance, including prediabetes and type 2 diabetes", "note": "Open-label semaglutide plus lifestyle counseling vs lifestyle counseling alone.", "decided_by": "both_coders" }, { "nct": "NCT05822830", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Open-label tirzepatide vs semaglutide; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05841238", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "healthy adults with overweight or obesity", "note": "LY3502970 is orforglipron; open-label sequential formulation/dose periods in one cohort, no placebo; groups are study periods, not randomized arms.", "decided_by": "both_coders" }, { "nct": "NCT05869903", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "orforglipron" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "obesity or overweight without diabetes, normoglycemia or prediabetes", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05872620", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "orforglipron" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "type 2 diabetes with obesity or overweight", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05891496", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "standard of care" } ], "population": "other", "population_note": "Alzheimer's disease", "note": "12-week randomized period only; EG002 is period 2 where everyone received semaglutide, left out.", "decided_by": "both_coders" }, { "nct": "NCT05931380", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "orforglipron" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "Japanese adults with obesity disease", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05963022", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "tirzepatide" ], "background": "none" } ], "population": "type2_diabetes", "population_note": "", "note": "Monotherapy.", "decided_by": "both_coders" }, { "nct": "NCT05971940", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "orforglipron" ], "background": "diet and exercise" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT06010004", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label orforglipron dose groups only; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT06023095", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "orforglipron" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "LY3502970 is orforglipron. Two titration cohorts (16 and 24 weeks) share one pooled placebo group.", "decided_by": "both_coders" }, { "nct": "NCT06041217", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "semaglutide" ], "background": "reduced-calorie diet and increased physical activity" } ], "population": "overweight_obesity", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT06045221", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "population": "type2_diabetes", "population_note": "", "note": "Open-label orforglipron vs oral semaglutide on metformin; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT06109311", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "orforglipron" ], "background": "insulin glargine with or without metformin and/or SGLT-2 inhibitor" } ], "population": "type2_diabetes", "population_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT06124807", "eligible": true, "exclusion_reason": null, "comparisons": [ { "glp1_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "mazdutide" ], "background": "none" } ], "population": "overweight_obesity", "population_note": "", "note": "LY3305677 is mazdutide.", "decided_by": "both_coders" }, { "nct": "NCT06440980", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "otherwise healthy adults with overweight or obesity", "note": "Open-label orforglipron capsule vs tablet bioequivalence study; groups are dosing periods, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT06482112", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "other", "population_note": "metabolic dysfunction-associated steatotic liver disease", "note": "Open-label comparison of efinopegdutide dosing regimens; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT06533527", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "mixed", "population_note": "people already taking incretin therapy (type 2 diabetes, obesity) scheduled for upper endoscopy", "note": "Continuing vs holding an unspecified current GLP-1 medication before endoscopy; hold arm gets no placebo.", "decided_by": "both_coders" }, { "nct": "NCT06640972", "eligible": false, "exclusion_reason": "no_glp1_group", "comparisons": [], "population": "overweight_obesity", "population_note": "people discontinuing semaglutide or tirzepatide for obesity", "note": "Tests RDX-002 (gut MTP inhibitor) vs placebo after GLP-1 discontinuation; no arm receives a GLP-1 RA.", "decided_by": "both_coders" }, { "nct": "NCT06771115", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "population": "overweight_obesity", "population_note": "", "note": "Factorial with VTX3232: semaglutide was injected on top of oral VTX3232 or its oral placebo, and the groups without semaglutide got no placebo injection, so the oral placebo is background shared by both sides and semaglutide was unmasked. If accepted, EG002 vs EG000 and EG003 vs EG001.", "decided_by": "third_reader" } ]