Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 323
Healthy volunteers: no

Brief summary:
Primary Objective:

* The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

* To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

  * Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
  * Percentage of participants reaching HbA1c \<7% or ≤6.5%;
  * 7-point Self-Monitored Plasma Glucose (SMPG) profile;
  * Body weight;
  * Insulin glargine dose
  * Fasting Plasma Glucose (FPG);
  * Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
* To assess safety and tolerability of insulin glargine/lixisenatide FRC.

Detailed description:
Approximately 27 weeks including a 24-week treatment period.

Arms:
arm 1: FRC injected once daily (QD) for 24 weeks. Dose individually adjusted. arm 2: Insulin glargine QD for 24 weeks. Dose individually adjusted.

Interventions: intervention 1: Insulin glargine /lixisenatide Fixed Ratio Combination intervention 2: Insulin glargine intervention 3: Metformin (Background drug)
Intervention descriptions: intervention 1: FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using pen-type injector (Tactipen®): 100 U/ml insulin glargine and 50 mcg Lixisenatide (ratio of 2 U/1 mcg). The initial dose was 10 U/5 mcg and then dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L. intervention 2: Insulin glargine (100 U/ml) was self-administered by SC injection before breakfast using pen-type injector (Lantus® Solostar®). The initial daily dose of insulin glargine was 10 U and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). intervention 3: Pharmaceutical form: Tablet; Route of administration: oral administration. To be kept at stable dose (≥1.5 g/day) throughout the study.

Protocol document: