Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

What this study is testing ClinicalTrials.gov NCT01117350 ↗

Description as written by the study sponsor.

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

Treatments tested

• Insulin glargine also known as Lantus® Drug

  100 Units/mL solution for injection in a pre-filled SoloStar pen

• Liraglutide also known as Victoza® Drug

  6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)

• Metformin Drug

  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.