Last updated: 11/07/2018 14:48:04
A 26-Week Randomized, Double-Blind Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone 8mg/day (4mg bd) Versus Placebo in Combination with Glyburide in Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A 26-Week Randomized, Double-Blind Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone 8mg/day (4mg bd) Versus Placebo in Combination with Glyburide in Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide
Trial description: A 26-Week Randomized, Double-Blind Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone 8mg/day (4mg bd) Versus Placebo in Combination with Glyburide in Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cobitz A, Deacon L, Stewart M. Rosiglitazone: effects on the insulin resistance metabolic syndrome. Can J Diabetes Care 2001; 25 (3). Poster 170 presented at the 5th Annual CDA/CSEM Professional Conference 2001.
Diabetologia 2000; 43 (Suppl 1):A267. Poster 1024 presented at EASD 2000.
Freed M, Fuell D, Menci L, et al. Effect of combination therapy with rosiglitazone and glibenclamide on PAI-1 antigen, PAI-1 activity and tPA in patients with type 2 diabetes.
Garber A, Cobitz AR, Deacon L, et al. Rosiglitazone: effects on the insulin resistance metabolic syndrome. Published in ENDO 2001 congress book: abstract 36051, poster P3-61.
Goldstein BJ, Fuell D, Menci L, et al. Rosiglitazone in combination with glibenclamide: effect on PAI-1 antigen, PAI-1 activity and tPA in patients with type 2 diabetes. Diabetes Res Clin Prac 2000; 50 (Suppl 1):S64. Poster 310 presented at IDF 2000.
Rosenstock J, Kreider M, Menci L, et al. Efficacy and safety of rosiglitazone combined with glibenclamide is effective and well tolerated in type 2 diabetes patients inadequately controlled on maximum-dose glibenclamide. Diabetes Research and Clinical Practice 2000; 50 (Suppl 1):S61. Poster 300 presented at IDF 2000.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
October 1998 to December 1999
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1999-07-12
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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