Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

What this study is testing ClinicalTrials.gov NCT03529123 ↗

Description as written by the study sponsor.

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c). Secondary Objectives: * To assess the effects of the FRC in comparison with insulin glargine on: * Percentage of patients reaching HbA1c targets (\<7% ); * Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG); * Body weight * Fasting Plasma Glucose (FPG); * Percentage of patients reaching HbA1c targets of \<7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria); * 7-point Self-Monitoring Plasma Glucose (SMPG) profile; * Insulin glargine dose. * To assess the safety and tolerability in each treatment group.

Treatments tested

• INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010) also known as Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination Drug

  Pharmaceutical form: Injection Route of administration: Subcutaneous

• INSULIN GLARGINE (HOE901) also known as Lantus® Drug

  Pharmaceutical form: Injection Route of administration: Subcutaneous

• Metformin Drug

  Pharmaceutical form: Tablet Route of administration: Oral

• Insulin Glulisine (HMR1964) also known as Apidra Drug

  Pharmaceutical form: Injection Route of administration: Subcutaneous