Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00297063
First received: February 24, 2006
Last updated: October 27, 2016
Last verified: October 2016

February 24, 2006
October 27, 2016
January 2006
Not Provided
HbA1c change from baseline at Week 28. [ Time Frame: 28 Weeks ]
HbA1c change from baseline at Week 28.
Complete list of historical versions of study NCT00297063 on ClinicalTrials.gov Archive Site
Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group. [ Time Frame: 28 Weeks ]
Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.
Not Provided
Not Provided
 
BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-
Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo -
This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Rosiglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
May 2007
Not Provided

Inclusion criteria:

  • Type 2 diabetes mellitus.
  • Managed by diet therapy.
  • Must have adequate blood, liver and kidney function.

Exclusion criteria:

  • Serious cardiovascular disease or serious hepatic disease.
Both
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00297063
AVD104742
No
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP