Study S000587

An Open-label, Randomized Two-arm Parallel Group Study to Compare the Effects of 4-week QD Treatment With Lixisenatide or Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01175473
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: NONE
Status: COMPLETED
Enrollment: 148
Start: 2010-08
Primary completion: 2010-11
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DEVICE:Pen auto-injector; DRUG:Liraglutide; DEVICE:Pre-filled pen injector; DRUG:Metformin
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2009-017666-23; OTHER:U1111-1116-9040; NIH:2009

Registered primary outcomes

Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28 [0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0022723	Pharmacodynamic characteristics of lixisenatide once daily versus liraglutide once daily in patients with type 2 diabetes insufficiently controlled on metformin. Kapitza C, Diabetes, obesity & metabolism	2013	Randomized trial	PMID 23368510 DOI	cites ClinicalTrials.gov:NCT01175473; registry reference RESULT:23368510