GSK-49653/082

Study Sponsor: GSK

Study Title

A 26-Week Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of BRL 49653C when Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on Insulin Monotherapy

Medicine or Vaccine (generic name)

rosiglitazone

Sponsor Identification Number

49653/082

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=49653/082

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

Extension study 49653/114 was conducted. An analysis-ready dataset and reporting and analysis plan are not available for this study. An annotated case report form is not available for this study. A blank case report form will be provided. 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

July 2015