Study S000191

A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01476475
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: NONE
Status: COMPLETED
Enrollment: 323
Start: 2011-11
Primary completion: 2012-12
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Insulin glargine /lixisenatide Fixed Ratio Combination; DRUG:Insulin glargine; DRUG:Metformin (Background drug)
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2011-002090-36; OTHER:U1111-1121-7111

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
R0021236	Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial. Rosenstock J, Diabetes care	2016	Randomized trial	PMID 27284114 DOI	cites ClinicalTrials.gov:NCT01476475; registry reference RESULT:27284114