{"protocolSection":{"identificationModule":{"nctId":"NCT03434119","orgStudyIdInfo":{"id":"LPS14860"},"secondaryIdInfos":[{"id":"U1111-1200-1891","type":"OTHER","domain":"UTN"}],"organization":{"fullName":"Sanofi","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents","officialTitle":"A 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents","acronym":"LixiLan-D"},"statusModule":{"statusVerifiedDate":"2022-03","overallStatus":"TERMINATED","whyStopped":"(\"Trial terminated (recruitment delays)\")","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-02-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-01-07","type":"ACTUAL"},"completionDateStruct":{"date":"2019-01-07","type":"ACTUAL"},"studyFirstSubmitDate":"2018-02-09","studyFirstSubmitQcDate":"2018-02-09","studyFirstPostDateStruct":{"date":"2018-02-15","type":"ACTUAL"},"resultsFirstSubmitDate":"2019-12-24","resultsFirstSubmitQcDate":"2020-01-09","resultsFirstPostDateStruct":{"date":"2020-01-13","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-03-21","lastUpdatePostDateStruct":{"date":"2022-03-28","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Sanofi","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"Primary Objective:\n\n* To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population.\n* To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians).\n\nSecondary Objective:\n\n* To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated.\n* To assess the change in daily insulin glargine dose within each ethnic/racial subgroup.\n* To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup.","detailedDescription":"The study duration was approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":241,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Soliqua 100/33","type":"EXPERIMENTAL","description":"Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.","interventionNames":["Drug: Insulin glargine/Lixisenatide","Drug: Background therapy"]},{"label":"Lantus","type":"ACTIVE_COMPARATOR","description":"Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.","interventionNames":["Drug: Insulin glargine (HOE901)","Drug: Background therapy"]}],"interventions":[{"type":"DRUG","name":"Insulin glargine/Lixisenatide","description":"Insulin glargine (100 units per milliliter \\[U/mL\\]) and lixisenatide (33 micrograms per milliliter \\[mcg/mL\\]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter \\[mmol/L\\]) while avoiding hypoglycemia.","armGroupLabels":["Soliqua 100/33"],"otherNames":["Soliqua 100/33","HOE901/AVE0010"]},{"type":"DRUG","name":"Insulin glargine (HOE901)","description":"Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.","armGroupLabels":["Lantus"],"otherNames":["Lantus","HOE901"]},{"type":"DRUG","name":"Background therapy","description":"Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.","armGroupLabels":["Lantus","Soliqua 100/33"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26","description":"Change in HbA1c was calculated by subtracting baseline value from Week 26 value.","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Achieving HbA1c Target of <7% at Week 26","description":"Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.","timeFrame":"Week 26"},{"measure":"Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26","description":"The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Daily Insulin Glargine Dose at Week 26","description":"Change in daily dose was calculated by subtracting baseline value from Week 26 value.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Body Weight at Week 26","description":"Change in body weight was calculated by subtracting baseline value from Week 26 value.","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period","description":"Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of \\<=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose \\<=70 mg/dL (3.9 mmol/L) and excluding plasma glucose \\<54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of \\<54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose \\<54 mg/dL (3.0 mmol/L) regardless of symptoms.","timeFrame":"Baseline to Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria :\n\n* Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the screening visit (signing of informed consent).\n* Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c (HbA1c) between 7.5% and 10% (inclusive).\n* Participants who were Hispanics of any race, non-Hispanic black/African Americans or non-Hispanic Asians. Note: Decision for ethnic/racial inclusion was made based on the participant's self-identification. Mixed-race participants must select 1 of the above-mentioned categories. If such selection could not be made, the candidate would be ineligible to participate in the study.\n* Participants who had been treated with any basal insulin (ie, glargine - U100 or U300, detemir, degludec, intermediate-acting \\[human Neutral Protamine Hagedorn (NPH\\]) for at least 6 months prior to Visit 1.\n* The basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to Visit 1.\n* The basal insulin dose had been stable (defined as up to ±20% \\[1/5 of the dose\\] variability) for at least 2 months prior to Visit 1 within the following dose ranges:\n* 15 to 50 units/day if HbA1c at Visit 1 is less than or equal to (\\<=)8.5%, and\n* 15 to 40 units/day if HbA1c at Visit 1 is greater than (\\>)8.5%.\n* Participants receiving 1 or 2 of the following OAD drugs: metformin, pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (SGLT-2) inhibitor or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1.\n\nExclusion criteria:\n\n* Age \\<18 years of age at Visit 1.\n* A body mass index (BMI) \\<=20 or \\>40 kg/m\\^2 at Visit 1.\n* Fasting plasma glucose (FPG) \\>200 mg/dL (by central lab measurement) at Visit 1 (1-time repeat measurement before Visit 2 is permitted).\n* Type 1 DM or any diabetes other than T2DM.\n* Any use of OAD drugs other than those described in the inclusion criteria (e.g., but not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl peptidase 4 (DPP4) inhibitors) within 12 weeks prior Visit 1.\n* Use of any other type of insulin except for basal insulin (e.g., prandial or premixed insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term treatment (i.e, \\<=10 days) with other insulin types due to intercurrent illness was permitted at the discretion of the Investigator.\n* Known history of discontinuation of treatment with a GLP-1 RA due to safety/tolerability reasons.\n* Use of systemic glucocorticoids for a total duration of \\>7 days within 12 weeks prior to Visit 1.\n* Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit 1.\n\nThe above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Sciences & Operations","affiliation":"Sanofi","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Investigational Site Number 8400072","city":"Montgomery","state":"Alabama","zip":"36106","country":"United 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8400069","city":"Anaheim","state":"California","zip":"92805","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Investigational Site Number 8400060","city":"Burbank","state":"California","zip":"91505","country":"United States","geoPoint":{"lat":34.18084,"lon":-118.30897}},{"facility":"Investigational Site Number 8400049","city":"Cerritos","state":"California","zip":"90703","country":"United States","geoPoint":{"lat":33.85835,"lon":-118.06479}},{"facility":"Investigational Site Number 8400078","city":"Chula Vista","state":"California","zip":"91910","country":"United States","geoPoint":{"lat":32.64005,"lon":-117.0842}},{"facility":"Investigational Site Number 8400047","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Investigational Site Number 8400066","city":"Fountain Valley","state":"California","zip":"92708","country":"United 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8400302","city":"Los Angeles","state":"California","zip":"90094","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Investigational Site Number 8400303","city":"Los Angeles","state":"California","zip":"90094","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Investigational Site Number 8400304","city":"Los Angeles","state":"California","zip":"90094","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Investigational Site Number 8400006","city":"Los Gatos","state":"California","zip":"95032","country":"United States","geoPoint":{"lat":37.22661,"lon":-121.97468}},{"facility":"Investigational Site Number 8400048","city":"Oakland","state":"California","zip":"94612","country":"United States","geoPoint":{"lat":37.80437,"lon":-122.2708}},{"facility":"Investigational Site Number 8400053","city":"Orange","state":"California","zip":"92868","country":"United 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8400017","city":"Miami","state":"Florida","zip":"33176","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Investigational Site Number 8400016","city":"Miami Lakes","state":"Florida","zip":"33014","country":"United States","geoPoint":{"lat":25.90871,"lon":-80.30866}},{"facility":"Investigational Site Number 8400014","city":"Ocoee","state":"Florida","zip":"34761","country":"United States","geoPoint":{"lat":28.56917,"lon":-81.54396}},{"facility":"Investigational Site Number 8400028","city":"Port Charlotte","state":"Florida","zip":"33952","country":"United States","geoPoint":{"lat":26.97617,"lon":-82.09064}},{"facility":"Investigational Site Number 8400097","city":"St. Petersburg","state":"Florida","zip":"00000","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"Investigational Site Number 8400035","city":"St. Petersburg","state":"Florida","zip":"33713","country":"United 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8400038","city":"Chicago","state":"Illinois","zip":"60607","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Investigational Site Number 8400088","city":"Chicago","state":"Illinois","zip":"60607","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Investigational Site Number 8400031","city":"Des Plaines","state":"Illinois","zip":"60018","country":"United States","geoPoint":{"lat":42.03336,"lon":-87.8834}},{"facility":"Investigational Site Number 8400064","city":"Evanston","state":"Illinois","zip":"60201","country":"United States","geoPoint":{"lat":42.04114,"lon":-87.69006}},{"facility":"Investigational Site Number 8400057","city":"Gurnee","state":"Illinois","zip":"60031","country":"United States","geoPoint":{"lat":42.3703,"lon":-87.90202}},{"facility":"Investigational Site Number 8400030","city":"Gretna","state":"Louisiana","zip":"70053","country":"United 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8400012","city":"Flint","state":"Michigan","zip":"48532-3447","country":"United States","geoPoint":{"lat":43.01253,"lon":-83.68746}},{"facility":"Investigational Site Number 8400090","city":"Las Vegas","state":"Nevada","zip":"89117","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Investigational Site Number 8400082","city":"Las Vegas","state":"Nevada","zip":"89148","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Investigational Site Number 8400018","city":"Linden","state":"New Jersey","zip":"07036","country":"United States","geoPoint":{"lat":40.62205,"lon":-74.24459}},{"facility":"Investigational Site Number 8400003","city":"The Bronx","state":"New York","zip":"10455","country":"United States","geoPoint":{"lat":40.84985,"lon":-73.86641}},{"facility":"Investigational Site Number 8400062","city":"Philadelphia","state":"Pennsylvania","zip":"19107","country":"United 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8400039","city":"Kerrville","state":"Texas","zip":"78028","country":"United States","geoPoint":{"lat":30.04743,"lon":-99.14032}},{"facility":"Investigational Site Number 8400096","city":"Lufkin","state":"Texas","zip":"75904","country":"United States","geoPoint":{"lat":31.33824,"lon":-94.7291}},{"facility":"Investigational Site Number 8400027","city":"San Antonio","state":"Texas","zip":"78228","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Investigational Site Number 8400083","city":"San Antonio","state":"Texas","zip":"78230","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Investigational Site Number 8400008","city":"Splendora","state":"Texas","zip":"77372","country":"United States","geoPoint":{"lat":30.23299,"lon":-95.16104}},{"facility":"Investigational Site Number 8400055","city":"Spring","state":"Texas","zip":"77379","country":"United States","geoPoint":{"lat":30.07994,"lon":-95.41716}},{"facility":"Investigational Site Number 8400070","city":"Sugar Land","state":"Texas","zip":"77478","country":"United States","geoPoint":{"lat":29.61968,"lon":-95.63495}},{"facility":"Investigational Site Number 8400085","city":"Sugar Land","state":"Texas","zip":"77479","country":"United States","geoPoint":{"lat":29.61968,"lon":-95.63495}},{"facility":"Investigational Site Number 8400059","city":"Webster","state":"Texas","zip":"77598","country":"United States","geoPoint":{"lat":29.53773,"lon":-95.11826}},{"facility":"Investigational Site Number 8400044","city":"Manassas","state":"Virginia","zip":"20110","country":"United States","geoPoint":{"lat":38.75095,"lon":-77.47527}},{"facility":"Investigational Site Number 8400068","city":"Norfolk","state":"Virginia","zip":"23510","country":"United States","geoPoint":{"lat":36.84681,"lon":-76.28522}},{"facility":"Investigational Site Number 8400033","city":"Richmond","state":"Virginia","zip":"23219","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Investigational Site Number 8400029","city":"Richland","state":"Washington","zip":"99352","country":"United States","geoPoint":{"lat":46.28569,"lon":-119.28446}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Randomization was stratified by self-reported ethnic/racial group, screening HbA1c values (\\<8.5% vs \\>=8.5%), background use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors (yes/no), background use of sulfonylureas (yes/no). Assignment to arms was done centrally by an interactive response technology (IRT) in 1:1 ratio (Soliqua 100/33:Lantus).","recruitmentDetails":"The study was conducted at 94 sites in United States (US). A total of 534 participants were screened between 20 February 2018 and 01 November 2018, of which 293 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level less than (\\<)7.5% or greater than (\\>)10% at the screening visit.","groups":[{"id":"FG000","title":"Soliqua 100/33","description":"Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks."},{"id":"FG001","title":"Lantus","description":"Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"116"},{"groupId":"FG001","numSubjects":"125"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"115"},{"groupId":"FG001","numSubjects":"125"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"NOT 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