Type II Diabetes Mellitus MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that can be a sulfonylurea, a glinide, a sodium glucose co-transporter 2 inhibitor or a dipeptidyl peptidase 4 (DPP4) inhibitor, and who are not adequately controlled with this treatment; • Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 920 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 205
Exclusion criteria
Exclusion criteria: • HbA1c at screening visit: - less than 7.5% or more than 10% for patients previously treated with metformin alone, - less than 7.0% or more than 9 % for patients previously treated with metformin and a second oral anti-diabetic treatment; • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method; • Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening. • Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician) • History of discontinuation of a previous treatment with a GLP-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy; • Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or has previously received lixisenatide. • Any contraindication to metformin use, according to local labeling • Use of weight loss drugs within 3 months prior to screening visit. • Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period. • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). • Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit • At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m² • At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range, • At screening visit ALT or AST more than 3 ULN • At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L) Exclusion Criteria for randomization at the end of the screening period: • HbA1c less than 7% or above 10%; • Fasting Plasma glucose above 250mg/dL (13.9 mmol/L); • Metformin maximal tolerated dose less than 1500 mg/day; • Amylase and/or lipase more than 3 ULN;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in HbA1c change from baseline to week 30;Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in patients with type 2 diabetes;Primary end point(s): Change in HbA1c from baseline;Timepoint(s) of evaluation of this end point: week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients reaching HbA1c targets - Change in 2-hour Post Prandial Glucose and in blood glucose excursion during standardized meal test from baseline - Change in body weight from baseline - Change in 7-point Self Measured Plasma Glucose profiles from baseline - Daily dose of insulin glargine - Change in Fasting Plasma Glucose from baseline - Documented (plasma glucose less than or equal to 70 mg/dl) symptomatic hypoglycemia - Severe symptomatic hypoglycemia ;Timepoint(s) of evaluation of this end point: Week 30/ 30 weeks | — |
Countries
Australia, Belgium, Canada, Chile, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactMedical Information
sanofi-aventis recherche & développement
Outcome results
None listed