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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下载链接:
https://doi.org/10.25934/PR00007622
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资源简介:
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



