Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 9:52 PM
Study NCT ID:
NCT01596504
Status:
COMPLETED
Last Update Posted:
2016-10-14
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
\- 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).
Detailed Description:
Up to 2-week screening period
* A run-in period of 12 weeks at maximum including a forced titration with insulin glargine up to 11 weeks and 1 baseline pharmacodynamic assessment week
* A 8-week treatment(s) period(s) up to Day 57
* Follow-up: 7 ±2 days after the last treatment day
* Total study duration approximately 14 weeks up to 23 weeks
* A run-in period of 12 weeks at maximum including a forced titration with insulin glargine up to 11 weeks and 1 baseline pharmacodynamic assessment week
* A 8-week treatment(s) period(s) up to Day 57
* Follow-up: 7 ±2 days after the last treatment day
* Total study duration approximately 14 weeks up to 23 weeks
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: