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
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资源简介:
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.
提供机构:
Vivli
创建时间:
2022-02-10



