SANOFI-EFC11629

Study Sponsor : Sanofi

Study Title

6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination with Oral Antihyperglycemic Drug(s) in Patients with Type 2 Diabetes Mellitus with a 6-Month Safety Extension Period

Medicine or Vaccine (generic name)

Insulin Glargine 300 U/ml

Sponsor Identification Number

EFC11629

Trial Registry Identification Number(#'s)

NCT01499095
EudraCT2010-023770-39

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/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/common/docs/clinical-study-results/efc11629_summary.pdf

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

https://www.clinicaltrials.gov/ct2/show/study/NCT01499095?term=EFC11629&rank=1

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-023770-39

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. 12-month datasets will be made available. There are 3 clinical study reports for the main 6 months, for the Substudy Comparing Adaptable Dosing Intervals with Fixed Dosing Intervals and for the 12 months

Date Added to this Site

August 2015