Study S000189

A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

ClinicalTrials.gov record

Registration

Registration: NCT01517412
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 451
Start: 2012-02
Primary completion: 2013-05
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DEVICE:Self-injector pen device (OptiClik®); DRUG:Metformin
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2011-002416-85; OTHER:U1111-1118-0841

Registered primary outcomes

Change in HbA1c From Baseline to Week 24 [Baseline, Week 24]

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
R0025701	Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. Ahrén B, Journal of diabetes and its complications	2014	Randomized trial	PMID 25012990 DOI	registry reference RESULT:25012990