A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00432679
First received: February 6, 2007
Last updated: October 1, 2010
Last verified: October 2010

February 6, 2007
October 1, 2010
May 2006
March 2007   (final data collection date for primary outcome measure)
Change from baseline in HbA1c after 16 weeks of treatment in rosiglitazone group and placebo group [ Time Frame: 16 Weeks ]
Change from baseline in HbA1c after 16 weeks of treatment in rosiglitazone group and placebo group
Complete list of historical versions of study NCT00432679 on ClinicalTrials.gov Archive Site
Change from baseline after 16 weeks of treatment in FPG; fasting insulin, fasting proinsulin, HOMA-IR and HOMA-; adiponectin, leptin and hs-CRP Proportion of cases with changes in HbA1c and FPG meeting specified criteria after 16 weeks of treatment [ Time Frame: 16 Weeks ]
Change from baseline after 16 weeks of treatment in FPG; fasting insulin, fasting proinsulin, HOMA-IR and HOMA-; adiponectin, leptin and hs-CRP Proportion of cases with changes in HbA1c and FPG meeting specified criteria after 16 weeks of treatment
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A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With SU) - A Placebo-Controlled Double-Blind Study -

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

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 (BRL49653C)
Other Name: Rosiglitazone (BRL49653C)
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion criteria:

  • Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00432679
AVD105248
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, Mr GlaxoSmithKline
GlaxoSmithKline
October 2010

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