Clinical trial NCT01117350
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Start date: 2010-07-01; Completion date: 2013-03-01
Enrollment: 978 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents

Secondary objectives of the comparative period (24 weeks):

\>To assess the effect of insulin glargine in comparison with liraglutide on:

* HbA1c level
* Percentage of patients whose HbA1c has decreased but remains \>= 7% at the end of the comparative period
* Percentage of patients whose HbA1c has increased at the end of the comparative period
* Fasting Plasma Glucose (FPG)
* 7-point Plasma Glucose (PG) profiles
* Hypoglycemia occurrence
* Body weight
* Adverse events

Objectives of the extension period (24 weeks):

\>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:

* HbA1c level
* FPG
* 7-point PG profiles
* Hypoglycemia occurrence
* Body weight
* Adverse events

Detailed description:
Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow:

* A 2-week of screening period,
* A 24-week comparative period,
* A 24-week extension period (only for patients treated with liraglutide, not adequately controlled at the end of the comparative period),
* A 1-week follow-up period

Arms: arm 1: Insulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study.

The starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 \< FPG ≤ 100 mg/dL (3.9 \< FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation. arm 2: Liraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study.

The dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.
Interventions: intervention 1: Insulin glargine intervention 2: Liraglutide intervention 3: Metformin
Intervention descriptions: intervention 1: 100 Units/mL solution for injection in a pre-filled SoloStar pen intervention 2: 6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg) intervention 3: Metformin was a background treatment, mandatory for each patient randomized in the study (at the minimum dose of 1g/day). It was not supplied by the sponsor.

Protocol documents: