GSK-797620/004

Study Sponsor: GSK

Study Title

A multi-center, randomized, double-blind, parallel group trial to compare the efficacy and safety of fixed-dose rosiglitazone/glimepiride combination therapy to glimepiride monotherapy and rosiglitazone monotherapy in drug naïve subjects with type 2 diabetes mellitus

Medicine or Vaccine (generic name)

rosiglitazone/glimepiride

Sponsor Identification Number

797620/004

Trial Registry Identification Number(#'s)

Medical Condition

Diabetes Mellitus, Type 2

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=797620/004

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

Link to study details on EudraCT (if available)

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

A link to ClinicalTrials.gov and an NCTID number are not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

February 2015