Last updated: 07/17/2024 17:47:27
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Combination Therapy with Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -
Trial description: This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in glycosylated hemoglobin (HbA1c) after 16 weeks of treatment in rosiglitazone group and placebo group
Timeframe: Baseline (Day 0) and Week 16
Secondary outcomes:
Change from Baseline after 16 weeks of treatment in fasting plasma glucose (FPG)
Timeframe: Baseline (Day 0) and Week 16
Change from Baseline after 16 weeks of treatment in fasting insulin
Timeframe: Baseline (Day 0) and Week 16
Change from Baseline after 16 weeks of treatment in fasting proinsulin
Timeframe: Baseline (Day 0) and Week 16
Change from Baseline after 16 weeks of treatment in homeostasis model assessment of insulin resistance (HOMA-IR)
Timeframe: Baseline (Day 0) and Week 16
Change from Baseline after 16 weeks of treatment in homeostasis model assessment of beta-cell function (HOMA-beta)
Timeframe: Baseline (Day 0) and Week 16
Change from Baseline after 16 weeks of treatment in adiponectin
Timeframe: Baseline (Day 0) and Week 16
Change from Baseline after 16 weeks of treatment in leptin and high sensitivity C-reactive protein (hs-CRP)
Timeframe: Baseline (Day 0) and Week 16
Percentage of participants with changes in HbA1c and FPG meeting specified criteria after 16 weeks of treatment
Timeframe: Up to Week 16
Interventions:
Drug: Rosiglitazone (BRL49653C)
Enrollment:
149
Observational study model:
Not applicable
Primary completion date:
2007-28-03
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
May 2006 to March 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- 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.
- Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
Inclusion and exclusion criteria
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.
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-28-03
Actual study completion date
2007-28-03
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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