Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Study Overview
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Brief Summary
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Primary Objective: - To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients. Secondary Objectives: To assess the effects of lixisenatide over 24 weeks on : percentage of patients reaching HbA1c<7% or ≤6.5%, 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profile), body weight, change in daily basal insulin dose. To assess lixisenatide safety and tolerability. To assess anti-lixisenatide antibody development.

Detailed Description
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Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Official Title
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A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Lixisenatide (AVE0010)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : - Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin. Exclusion criteria: At screening: Age < legal age of adulthood. HbA1c<7% or >10.5%. Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit. If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit. History of hypoglycemia unawareness. Body Mass Index (BMI) ≤20 kg/m². Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lixisenatide<br>24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day) | Drug: Lixisenatide (AVE0010)<br>* Pharmaceutical form:solution Route of administration: subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day) | Drug: Placebo<br>* Pharmaceutical form:solution Route of administration: subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | from baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with HbA1c <7%, =<6.5% |  | at week 24 | 
| Change in 2-hour postprandial plasma glucose and plasma glucose excursion |  | from baseline to week 24 | 
| Change in fasting plasma glucose |  | from baseline to week 24 | 
| Change in 7-point self monitoring plasma glucose profile (average and each point) |  | from baseline to week 24 | 
| Change in body weight |  | from baseline to week 24 | 
| Change in daily basal insulin dose |  | from baseline to week 24 | 
| Number of patients with adverse events |  | 24 weeks | 
| Anti-lixisenatide antibody assessment |  | from baseline to week 24 |