Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

What this study is testing ClinicalTrials.gov NCT01768559 ↗

Description as written by the study sponsor.

Primary Objective: \- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: \- To compare the treatments/regimens on: * The percentage of participants reaching the target of HbA1c \<7% or ≤6.5%, * Body weight, * Self-Monitored Glucose profiles, * Fasting Plasma Glucose (FPG), * Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants), * Daily doses of insulins, * Safety and tolerability.

Treatments tested

• Lixisenatide (AVE0010) also known as Lyxumia®, Device: Disposable self-injector prefilled pen (Delta 14®) Drug

  Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.

• Insulin glulisine QD also known as HMR1964, Device: Disposable self-injector prefilled pen (Apidra® Solostar®) Drug

  Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).

• Insulin glulisine TID also known as HMR1964, Device: Disposable self-injector prefilled pen (Apidra® Solostar®) Drug

  Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).

• Insulin Glargine (Mandatory background drug) also known as Device: Disposable self-injector prefilled pen (Lantus® Solostar®) Drug

  Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).

• Metformin (Background drug) Drug

  Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.