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Dataset from An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

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NIAID Data Ecosystem2026-05-02 收录
下载链接:
https://doi.org/10.25934/PR00007622
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Primary Objective: - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after a standardized breakfast at the end of a 8-week treatment period in participants with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin). Secondary Objectives: - To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after an 8-week treatment period in participants with T2DM not adequately controlled with insulin glargine (± metformin) on: - Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast, - Appetite perceptions after standardized dinner, - Gastric emptying after a standardized labelled test meal, - Fasting plasma glucose, 24-hour plasma glucose profile, - Glycosylated hemoglobin (HbA1c), - Insulin glargine dose, - 7-point self monitored plasma glucose (SMPG), - Body weight and waist circumference, - 24-hour heart rate and blood pressure, - To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin).
创建时间:
2025-02-22
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