{"protocolSection":{"identificationModule":{"nctId":"NCT00975286","orgStudyIdInfo":{"id":"EFC10781"},"secondaryIdInfos":[{"id":"EudraCT : 2008-007335-40"}],"organization":{"fullName":"Sanofi","class":"INDUSTRY"},"briefTitle":"24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine","officialTitle":"A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin","acronym":"GetGoal-Duo1"},"statusModule":{"statusVerifiedDate":"2016-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-10"},"primaryCompletionDateStruct":{"date":"2011-08","type":"ACTUAL"},"completionDateStruct":{"date":"2011-08","type":"ACTUAL"},"studyFirstSubmitDate":"2009-09-10","studyFirstSubmitQcDate":"2009-09-10","studyFirstPostDateStruct":{"date":"2009-09-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-08-18","resultsFirstSubmitQcDate":"2016-08-18","resultsFirstPostDateStruct":{"date":"2016-10-11","type":"ESTIMATED"},"dispFirstSubmitDate":"2012-05-07","dispFirstSubmitQcDate":"2012-05-07","dispFirstPostDateStruct":{"date":"2012-05-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-08-18","lastUpdatePostDateStruct":{"date":"2016-10-11","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Sanofi","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.\n\nThe primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.\n\nThe secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (\\<) 7 percent (%) and less than or equal to (\\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.","detailedDescription":"The study comprises 3 periods:\n\n* An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs.\n* At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or equal to (\\>=) 7% and less than or equal to (\\<=) 9% and whose mean fasting self-monitored plasma glucose (SMPG) calculated from the self measurements for the 7 days prior to Visit 12 (Week -1) is \\<=140 milligram per deciliter (mg/dL) (7.8 millimole per liter \\[mmol/L\\]), would enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/- TZDs).\n* A 3-day safety follow up period.\n\nMaximum duration is of 39 weeks +/- 7 days."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":446,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lixisenatide","type":"EXPERIMENTAL","description":"2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.","interventionNames":["Drug: Lixisenatide (AVE0010)","Drug: Insulin glargine","Device: Pen auto-injector","Drug: Metformin","Drug: Thiazolidinedione (TZD)"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.","interventionNames":["Drug: Placebo","Drug: Insulin glargine","Device: Pen auto-injector","Drug: Metformin","Drug: Thiazolidinedione (TZD)"]}],"interventions":[{"type":"DRUG","name":"Lixisenatide (AVE0010)","description":"Self administered by subcutaneous injections once daily within the hour preceding breakfast.","armGroupLabels":["Lixisenatide"]},{"type":"DRUG","name":"Placebo","description":"Self administered by subcutaneous injections once daily within the hour preceding breakfast.","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Insulin glargine","description":"Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.","armGroupLabels":["Lixisenatide","Placebo"],"otherNames":["Lantus®"]},{"type":"DEVICE","name":"Pen auto-injector","description":"Lantus® SoloStar® OptiClik®","armGroupLabels":["Lixisenatide","Placebo"]},{"type":"DRUG","name":"Metformin","description":"Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.","armGroupLabels":["Lixisenatide","Placebo"]},{"type":"DRUG","name":"Thiazolidinedione (TZD)","description":"TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.","armGroupLabels":["Lixisenatide","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"}],"secondaryOutcomes":[{"measure":"Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24","description":"The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Change From Baseline in Glucose Excursion at Week 24","description":"Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24","description":"Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Change From Baseline in Body Weight at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Change From Baseline in Average Insulin Glargine Daily Dose at Week 24","description":"Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Week 24"},{"measure":"Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Week 24"},{"measure":"Percentage of Patients Requiring Rescue Therapy During the Double-blind Period","description":"Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \\>200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c \\>9%, from Week 8 to Week 24: fasting SMPG/FPG \\>180 mg/dL (10.0 mmol/L) or HbA1c \\>8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline up to Week 24"},{"measure":"Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"}],"otherOutcomes":[{"measure":"Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","timeFrame":"Baseline, Week 24"},{"measure":"Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia","description":"Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.","timeFrame":"First dose of study drug up to 3 days after the last dose administration"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n\\- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with insulin glargine and metformin\n\nExclusion criteria:\n\n* HbA1c \\<7% or greater than (\\>)10% at screening\n* At the time of screening age \\< legal age of majority\n* Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method\n* Type 1 diabetes mellitus\n* Metformin not at a stable dose of at least 1.5 gram per day for at least 3 months prior to the screening visit\n* Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea (SU) and TZDs (for example, alpha glucosidase inhibitor, other glucagon like peptide-1 \\[GLP-1\\] receptor agonists, dipeptidyl peptidase-IV \\[DPP-IV\\] inhibitors, insulin etc.) within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit\n* History of hypoglycemia unawareness\n* Body Mass Index (BMI) less than or equal to (\\<=) 20 kilogram per square meter (kg/m\\^2)\n* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)\n* History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening\n* Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening\n* Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization\n* Known history of drug or alcohol abuse within 6 months prior to the time of screening\n* Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram or vital signs at the time of screening that in the judgment of the Investigator or any sub investigator precludes safe completion of the study or constrains efficacy assessment such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period\n* Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure \\>180 millimeter of mercury (mmHg) or \\>110 mmHg, respectively\n* Laboratory findings at the time of screening: amylase and/or lipase, alanine aminotransferase \\>3 times upper limit of the normal (ULN) laboratory range; total bilirubin: \\>1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin \\<11 gram/deciliter and/or neutrophils \\<1500 per cubic millimeter (mm\\^3) and/or platelets \\<100 000/mm\\^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, positive serum pregnancy test in females of childbearing potential; and calcitonin \\>=20 picogram per milliliter (pg/mL) (5.9 picomole per milliliter \\[pmol/L\\])\n* Patients who are considered by the Investigator or any sub investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, patient being investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol etc.)\n* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening\n* Use of any investigational drug within 3 months prior to screening\n* Renal impairment defined with serum creatinine \\> 1.4 mg/dL in women and \\> 1.5 mg/dL in men\n* History of hypersensitivity to insulin glargine or to any of the excipients\n* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening\n* Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)\n* Allergic reaction to any GLP-1 receptor agonist in the past (for example, exenatide, liraglutide) or to metacresol\n* Additional exclusion criteria during or at the end of the run-in phase before randomization: informed consent withdrawal (patient who was not willing to continue or failed to return), mean fasting SMPG calculated from the self-measurements for the 7 days prior to Visit 12 (Week -1) was \\>140 mg/dL (7.8 mmol/L) and HbA1c measured at Visit 12 (Week -1) is \\<7% or \\>9%, amylase and/or lipase \\> 3 times the ULN at Visit 12 (Week -1), patients with fasting plasma glucose (FPG) above the threshold value described for rescue (that is, FPG \\>240 mg/dL \\[13.3 mmol/L\\]), patients with any adverse event, which, by the judgment of the Investigator precludes the inclusion in the double-blind randomized treatment phase, and lack of compliance to protocol or to insulin glargine treatment during the run-in phase","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Study Operations","affiliation":"Sanofi","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Sanofi-Aventis Investigational Site Number 840223","city":"Mesa","state":"Arizona","zip":"85206","country":"United States","geoPoint":{"lat":33.42227,"lon":-111.82264}},{"facility":"Sanofi-Aventis Investigational Site Number 840206","city":"Hot Springs","state":"Arkansas","zip":"71913","country":"United States","geoPoint":{"lat":34.5037,"lon":-93.05518}},{"facility":"Sanofi-Aventis Investigational Site Number 840201","city":"Little Rock","state":"Arkansas","zip":"72205","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Sanofi-Aventis Investigational Site Number 840212","city":"Mountain Home","state":"Arkansas","zip":"72653","country":"United States","geoPoint":{"lat":36.33534,"lon":-92.38516}},{"facility":"Sanofi-Aventis Investigational Site Number 840215","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"Sanofi-Aventis Investigational Site Number 840214","city":"Greenbrae","state":"California","zip":"94904","country":"United States","geoPoint":{"lat":37.94854,"lon":-122.5247}},{"facility":"Sanofi-Aventis Investigational Site Number 840221","city":"Orlando","state":"Florida","zip":"32835","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Sanofi-Aventis Investigational Site Number 840211","city":"Baton Rouge","state":"Louisiana","zip":"70808","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"Sanofi-Aventis Investigational Site Number 840230","city":"Hyattsville","state":"Maryland","zip":"20781","country":"United States","geoPoint":{"lat":38.95594,"lon":-76.94553}},{"facility":"Sanofi-Aventis Investigational Site Number 840209","city":"Rockville","state":"Maryland","zip":"20852","country":"United States","geoPoint":{"lat":39.084,"lon":-77.15276}},{"facility":"Sanofi-Aventis Investigational Site Number 840219","city":"Brighton","state":"Michigan","zip":"48114","country":"United States","geoPoint":{"lat":42.52948,"lon":-83.78022}},{"facility":"Sanofi-Aventis Investigational Site Number 840231","city":"Sea Girt","state":"New Jersey","zip":"08750","country":"United States","geoPoint":{"lat":40.13206,"lon":-74.03458}},{"facility":"Sanofi-Aventis Investigational Site Number 840208","city":"Fargo","state":"North Dakota","zip":"58103","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Sanofi-Aventis Investigational Site Number 840225","city":"Mentor","state":"Ohio","zip":"44060","country":"United States","geoPoint":{"lat":41.66616,"lon":-81.33955}},{"facility":"Sanofi-Aventis Investigational Site Number 840222","city":"Portland","state":"Oregon","zip":"97201-3098","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Sanofi-Aventis Investigational Site Number 840202","city":"Philadelphia","state":"Pennsylvania","zip":"19146","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Sanofi-Aventis Investigational Site Number 840229","city":"Bristol","state":"Tennessee","zip":"37620","country":"United States","geoPoint":{"lat":36.59511,"lon":-82.18874}},{"facility":"Sanofi-Aventis Investigational Site Number 840205","city":"Germantown","state":"Tennessee","zip":"38138","country":"United States","geoPoint":{"lat":35.08676,"lon":-89.81009}},{"facility":"Sanofi-Aventis Investigational Site Number 840210","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Sanofi-Aventis Investigational Site Number 840217","city":"Houston","state":"Texas","zip":"77081","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Sanofi-Aventis Investigational Site Number 840228","city":"Houston","state":"Texas","zip":"77081","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Sanofi-Aventis Investigational Site Number 840213","city":"Plano","state":"Texas","zip":"75093","country":"United States","geoPoint":{"lat":33.01984,"lon":-96.69889}},{"facility":"Sanofi-Aventis Investigational Site Number 840227","city":"Norfolk","state":"Virginia","zip":"23502","country":"United States","geoPoint":{"lat":36.84681,"lon":-76.28522}},{"facility":"Sanofi-Aventis Investigational Site Number 032204","city":"Buenos Aires","country":"Argentina","geoPoint":{"lat":-34.61315,"lon":-58.37723}},{"facility":"Sanofi-Aventis Investigational Site Number 032205","city":"Capital Federal","zip":"1012","country":"Argentina"},{"facility":"Sanofi-Aventis Investigational Site Number 032201","city":"Capital Federal","zip":"1425","country":"Argentina"},{"facility":"Sanofi-Aventis Investigational Site Number 032209","city":"Capital Federal","zip":"C1056ABJ","country":"Argentina"},{"facility":"Sanofi-Aventis Investigational Site Number 032211","city":"Corrientes","country":"Argentina","geoPoint":{"lat":-27.46784,"lon":-58.8344}},{"facility":"Sanofi-Aventis Investigational Site Number 032202","city":"Paraná","zip":"(E3100BBJ)","country":"Argentina","geoPoint":{"lat":-31.73271,"lon":-60.52897}},{"facility":"Sanofi-Aventis Investigational Site Number 032203","city":"Rosario","zip":"2000","country":"Argentina","geoPoint":{"lat":-32.94682,"lon":-60.63932}},{"facility":"Sanofi-Aventis Investigational Site Number 076207","city":"Belém","zip":"66073-000","country":"Brazil","geoPoint":{"lat":-1.45583,"lon":-48.50444}},{"facility":"Sanofi-Aventis Investigational Site Number 076202","city":"Brasília","zip":"71625-009","country":"Brazil","geoPoint":{"lat":-15.77972,"lon":-47.92972}},{"facility":"Sanofi-Aventis Investigational Site Number 076205","city":"Porto Alegre","zip":"90035001","country":"Brazil","geoPoint":{"lat":-30.03283,"lon":-51.23019}},{"facility":"Sanofi-Aventis Investigational Site Number 076204","city":"São Paulo","zip":"04024-002","country":"Brazil","geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"facility":"Sanofi-Aventis Investigational Site Number 124219","city":"Brampton","zip":"L6R 3J5","country":"Canada","geoPoint":{"lat":43.68341,"lon":-79.76633}},{"facility":"Sanofi-Aventis Investigational Site Number 124213","city":"Chatham","zip":"N7L 1C1","country":"Canada","geoPoint":{"lat":42.41224,"lon":-82.18494}},{"facility":"Sanofi-Aventis Investigational Site Number 124208","city":"Chilliwack","zip":"V2P 4M9","country":"Canada","geoPoint":{"lat":49.16638,"lon":-121.95257}},{"facility":"Sanofi-Aventis Investigational Site Number 124215","city":"Etobicoke","zip":"M9R 4E1","country":"Canada","geoPoint":{"lat":43.64415,"lon":-79.56985}},{"facility":"Sanofi-Aventis Investigational Site Number 124205","city":"Québec","zip":"G1V 4G5","country":"Canada","geoPoint":{"lat":46.81228,"lon":-71.21454}},{"facility":"Sanofi-Aventis Investigational Site Number 124202","city":"Red Deer","zip":"T4N 6V7","country":"Canada","geoPoint":{"lat":52.26682,"lon":-113.802}},{"facility":"Sanofi-Aventis Investigational Site Number 124218","city":"Thornhill","zip":"L4J 8L7","country":"Canada","geoPoint":{"lat":43.815,"lon":-79.4242}},{"facility":"Sanofi-Aventis Investigational Site Number 124201","city":"Toronto","zip":"M4R 2G4","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Sanofi-Aventis Investigational Site Number 124207","city":"Toronto","zip":"M9V 4B4","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Sanofi-Aventis Investigational Site Number 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Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013 Sep;36(9):2497-503. doi: 10.2337/dc12-2462. Epub 2013 Apr 5."},{"pmid":"36809495","type":"DERIVED","citation":"Yao J, Zhang M, Zhang X, Zhang J. Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Diabetes Ther. 2023 Apr;14(4):653-669. doi: 10.1007/s13300-023-01369-6. Epub 2023 Feb 21."},{"pmid":"31956422","type":"DERIVED","citation":"Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020."},{"pmid":"29974618","type":"DERIVED","citation":"Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13."},{"pmid":"25130920","type":"DERIVED","citation":"Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. J Diabetes Complications. 2014 Nov-Dec;28(6):880-6. doi: 10.1016/j.jdiacomp.2014.07.007. Epub 2014 Jul 18."},{"pmid":"23628617","type":"DERIVED","citation":"Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 1470 patients were screened of which 1024 were screen or run-in failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 9%). 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Number of patients evaluable for this Baseline characteristic were 221 and 219 for Placebo and Lixisenatide arm, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.79","spread":"3.69"},{"groupId":"BG001","value":"12.90","spread":"3.94"},{"groupId":"BG002","value":"12.85","spread":"3.81"}]}]}]},{"title":"Glucose Excursion","description":"Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the meal test, before study drug administration. Number of patients evaluable for this Baseline characteristic were 221 and 219 for Placebo and Lixisenatide arm, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.33","spread":"3.54"},{"groupId":"BG001","value":"6.24","spread":"4.35"},{"groupId":"BG002","value":"6.29","spread":"3.96"}]}]}]},{"title":"Average 7-Point Self Monitored Plasma Glucose (SMPG)","description":"Patients recorded a 7-point plasma glucose profile before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. Number of patients evaluable for this Baseline characteristic were 221 and 221 for Placebo and Lixisenatide arm, respectively.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.26","spread":"1.52"},{"groupId":"BG001","value":"8.20","spread":"1.47"},{"groupId":"BG002","value":"8.23","spread":"1.49"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilogram (kg)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"86.75","spread":"20.41"},{"groupId":"BG001","value":"87.31","spread":"21.76"},{"groupId":"BG002","value":"87.03","spread":"21.07"}]}]}]},{"title":"Average Insulin Glargine Daily Dose","description":"Insulin glargine average daily dose at Baseline is the average daily dose for the week prior to Visit 12 (Week -1).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units per day","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.24","spread":"19.86"},{"groupId":"BG001","value":"43.44","spread":"18.84"},{"groupId":"BG002","value":"43.84","spread":"19.34"}]}]}]},{"title":"Treatment Satisfaction Score (Diabetes Treatment Satisfaction Questionnaire [DTSQ])","description":"DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 (worst case) to 6 (best case) except Q2 and 3 where 0 (best case) to 6 (worst case). Six items (Q1 and 4-8) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower score represented good perceived blood glucose control.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.5","spread":"5.1"},{"groupId":"BG001","value":"31.7","spread":"4.5"},{"groupId":"BG002","value":"31.6","spread":"4.8"}]}]}]},{"title":"Duration of Diabetes","description":"Duration of diabetes at screening is reported.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.72","spread":"5.82"},{"groupId":"BG001","value":"9.62","spread":"6.03"},{"groupId":"BG002","value":"9.17","spread":"5.94"}]}]}]},{"title":"Metformin Daily Dose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"milligram (mg) per day","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2058.1","spread":"430.6"},{"groupId":"BG001","value":"2039.2","spread":"405.3"},{"groupId":"BG002","value":"2048.7","spread":"417.8"}]}]}]},{"title":"Number of Patients With Thiazolidinedione (TZD) use at Baseline","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"54"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"196"},{"groupId":"BG001","value":"196"},{"groupId":"BG002","value":"392"}]}]}]},{"title":"Body Mass Index (BMI)","description":"BMI was calculated by dividing body weight by the height squared.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilogram per square meter (kg/m^2)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.65","spread":"6.01"},{"groupId":"BG001","value":"31.99","spread":"6.63"},{"groupId":"BG002","value":"31.82","spread":"6.32"}]}]}]},{"title":"Number of Patients With Categorical BMI","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Less than 30","categories":[{"measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"103"},{"groupId":"BG002","value":"206"}]}]},{"title":"Greater than or equal to 30","categories":[{"measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"240"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24","description":"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. Last observation carried forward used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of hemoglobin","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.40","spread":"0.092"},{"groupId":"OG001","value":"-0.71","spread":"0.091"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (\\<8.0,\\>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.","statisticalMethod":"ANCOVA","paramType":"[Least squares (LS) mean difference","paramValue":"-0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.463","ciUpperLimit":"-0.171","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.074"}]},{"type":"SECONDARY","title":"Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24","description":"The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period. Missing data was imputed using last observation carried forward (LOCF).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"194"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"0.481"},{"groupId":"OG001","value":"-3.09","spread":"0.482"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Glucose Excursion at Week 24","description":"Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period. Missing data was imputed using LOCF.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"194"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.33","spread":"0.461"},{"groupId":"OG001","value":"-3.42","spread":"0.462"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24","description":"Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period. Missing data was imputed using LOCF.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.08","spread":"0.179"},{"groupId":"OG001","value":"-0.47","spread":"0.178"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period. Missing data was imputed using LOCF.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"217"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.16","spread":"0.330"},{"groupId":"OG001","value":"0.28","spread":"0.331"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Average Insulin Glargine Daily Dose at Week 24","description":"Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline insulin glargine dose assessment during on-treatment period. Missing data was imputed using LOCF.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units per day","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"222"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.34","spread":"1.256"},{"groupId":"OG001","value":"3.10","spread":"1.260"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period. Missing data was imputed using LOCF.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"214"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.46","spread":"0.214"},{"groupId":"OG001","value":"0.34","spread":"0.213"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"217"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.2"},{"groupId":"OG001","value":"5.1"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.5"},{"groupId":"OG001","value":"56.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24","description":"The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.3"},{"groupId":"OG001","value":"32.1"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Requiring Rescue Therapy During the Double-blind Period","description":"Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \\>200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c \\>9%, from Week 8 to Week 24: fasting SMPG/FPG \\>180 mg/dL (10.0 mmol/L) or HbA1c \\>8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline up to Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"223"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.4"},{"groupId":"OG001","value":"0.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24","description":"Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.","populationDescription":"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline DTSQ assessment during on-treatment period. Missing data was imputed using LOCF.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, Week 24","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"201"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.65","spread":"0.545"},{"groupId":"OG001","value":"0.88","spread":"0.543"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia","description":"Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.","populationDescription":"Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"First dose of study drug up to 3 days after the last dose administration","groups":[{"id":"OG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo."},{"id":"OG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"223"}]}],"classes":[{"title":"Symptomatic hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"50"}]}]},{"title":"Severe symptomatic hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"First dose of study drug up to 3 days after the last dose administration","description":"Median exposure to study treatment was 169 days in both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.","eventGroups":[{"id":"EG000","title":"Placebo","description":"2-step initiation regimen of volume matching placebo.","seriousNumAffected":10,"seriousNumAtRisk":223,"otherNumAffected":81,"otherNumAtRisk":223},{"id":"EG001","title":"Lixisenatide","description":"2-step initiation regimen of lixisenatide.","seriousNumAffected":17,"seriousNumAtRisk":223,"otherNumAffected":127,"otherNumAtRisk":223}],"seriousEvents":[{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":223}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":223}]},{"term":"Urosepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":223}]},{"term":"Colon cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":223}]},{"term":"Multiple myeloma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":223},{"groupId":"EG001","numAffected":0,"numAtRisk":223}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":223}]},{"term":"Hypoglycaemic unconsciousness","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":223},{"groupId":"EG001","numAffected":1,"numAtRisk":223}]},{"term":"Schizophrenia, paranoid type","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 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