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Tracking Information | |||||
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First Received Date † | February 24, 2006 | ||||
Last Updated Date | October 15, 2008 | ||||
Start Date † | January 2006 | ||||
Current Primary Outcome Measures † |
HbA1c change from baseline at Week 28. [ Time Frame: 28 Weeks ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00297063 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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 ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy- | ||||
Official Title † | 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 - | ||||
Brief Summary | This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Non-Insulin-Dependent Diabetes Mellitus | ||||
Intervention † | Drug: Rosiglitazone | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 350 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 20 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00297063 | ||||
Responsible Party | Study Director, GSK | ||||
Secondary IDs †† | |||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |