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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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https://search.vivli.org/doiLanding/studies/PR00007690/isLanding
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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
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