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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00297063
First received: February 24, 2006
Last updated: October 1, 2010
Last verified: October 2010

February 24, 2006
October 1, 2010
January 2006
May 2007   (final data collection date for primary outcome measure)
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
Non-Insulin-Dependent Diabetes Mellitus
Drug: Rosiglitazone
Other Name: Rosiglitazone
Not Provided
Kikuchi M, Kaku K, Odawara M, Momomura S, Ishii R. Efficacy and tolerability of rosiglitazone and pioglitazone in drug-naïve Japanese patients with type 2 diabetes mellitus: a double-blind, 28 weeks' treatment, comparative study. Curr Med Res Opin. 2012 Jun;28(6):1007-16. doi: 10.1185/03007995.2012.694361. Epub 2012 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
May 2007
May 2007   (final data collection date for primary outcome measure)

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
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00297063
AVD104742
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2010

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