At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients
In Brief
A Phase 2 clinical trial evaluating Insulin glargine /lixisenatide Fixed Ratio Combination, Insulin glargine, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 323 participants across 70 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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).
Pharmaceutical form: Tablet; Route of administration: oral administration. To be kept at stable dose (≥1.5 g/day) throughout the study.