Health Condition 1: null- In patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin. Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Drug: lixisenatide (AVE0010): Drug: lixisenatide (AVE0010)
solution for subcutaneous injection
Drug: insulin glargine (HOE901)
solution for subcutaneous injection
24 weeks
Control I
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes mellitus, as defined by WHO (1), diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit. In addition to metformin, patients may receive sulfonylureas (that must be discontinued at visit 1) and/or thiazolidinediones (that can be continued).
Exclusion criteria
Exclusion criteria: At screening: - Pregnancy or lactation - Women of childbearing potential with no effective contraceptive method. - Type 1 diabetes mellitus - Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit. - Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea and thiazolidinediones 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. - History of hypoglycemia unawareness. - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease - History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening - Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening - Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization - Known history of drug or alcohol abuse within 6 months prior to the time of screening - Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively - Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening - Use of any investigational drug within 3 months prior to screening - Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men - History of hypersensitivity to insulin glargine or to any of the excipients - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e worsening) and not controlled (i.e prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening - Any previous treatment with lixisenatide (e.g. participation in a previous study with lixisenatide) - Allergic reaction to any GLP-1 receptor agonist in the past (e.g. exenatide, liraglutide) or to metacresol. Additional exclusion criteria during or at the end of the run-in phase before randomization : - Informed consent withdrawal (patient who is not willing to continue or fails to return) - Mean fasting SMPG calculated from the self-measurements for the 7 days prior to visit 12 (week -1) is > 126 mg/dl (7.0 mmol/l) - HbA1c measured at visit 12 (week -1) is < 7% or > 9 %, - Amylase and/or lipase > 3 times the upper limit of the normal laboratory range at visit 12 (week -1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycated hemoglobin (HbA1c)Timepoint: Time Frame: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with HbA1c 7 %Timepoint: 24 weeks | — |
Countries
Argentina, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Romania, Russian Federation, South Africa, Sweden, Taiwan, Ukraine, United States of America
Contacts
Public ContactSalini James
Sanofi-Synthelabo (India) Limited
Outcome results
None listed