Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1, metformin, insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 496
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without metformin over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.

The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed description:
Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patients.

Arms:
arm 1: 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 the end of treatment. arm 2: 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 the end of treatment.

Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Basal Insulin intervention 4: Metformin intervention 5: Pen auto-injector
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: Dose to be kept stable. intervention 4: Metformin if given to be continued at stable dose (1.5 gram per day) up to the end of treatment. intervention 5: None

Protocol document: