SANOFI-EFC12261

Study Sponsor : Sanofi

Study Title

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

Medicine or Vaccine (generic name)

Lixisenatide

Sponsor Identification Number

EFC12261

Trial Registry Identification Number(#'s)

NCT01517412
EudraCT2011-002416-85

Medical Condition

Diabetes Mellitus Type 2

Phase

Phase 3

Link to study details on the Sanofi Clinical Study Register

https://www.sanofi.com/en/science-and-innovation/clinical-trials-and-results/our-disclosure-commitments/pharma/letter-l/

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT01517412?term=NCT01517412&rank=1

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-002416-85

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Datasets and document are available as per Sanofi Policy and criteria

Date Added to this Site

April 2017