Last updated: 11/16/2022 12:10:16
BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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 -
Trial description: This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
HbA1c change from baseline at Week 28.
Timeframe: 28 Weeks
Secondary outcomes:
Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.
Timeframe: 28 Weeks
Interventions:
Drug: Rosiglitazone
Enrollment:
350
Observational study model:
Not applicable
Primary completion date:
2007-31-05
Time perspective:
Not applicable
Clinical publications:
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;28 (epub)(6):1007-16.
MacDonald M, Petrie M, Home P, Komajda M, Jones N, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock S, Curtis P, McMurray J. . Incidence and Prevalence of Unrecognized Myocardial Infarction in People With Diabetes Mellitus: A substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. . [Diabetes Care]. 2011;34:1394-1396.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
January 2006 to May 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
20 - 75 years
Accepts healthy volunteers
No
- Type 2 diabetes mellitus.
- Managed by diet therapy.
- Serious cardiovascular disease or serious hepatic disease.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-31-05
Actual study completion date
2007-31-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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