Last updated: 11/07/2018 14:49:59
A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Rosiglitazone in Combination with Glibenclamide Compared to Normal Upward Titration of Glibenclamide in Patients with Type 2 Diabetes Mellitus
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Rosiglitazone in Combination with Glibenclamide Compared to Normal Upward Titration of Glibenclamide in Patients with Type 2 Diabetes Mellitus
Trial description: A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Rosiglitazone in Combination with Glibenclamide Compared to Normal Upward Titration of Glibenclamide in Patients with Type 2 Diabetes Mellitus
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:
Abstract: 9/5/2004. RMIS IHealth Economics, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, 2york Health Economics Consortium, University of York, United Kingdom, 3Health Management, University of Erlangen-Nuernberg, Germany, 4Diabetes Center, Fachklinik Bad Heilbrunn, Germany. Munich; Germany
Kerenyi Z et al Rosiglitazone in combination with glibenclamide compared with uptitration of glibenclamide alone. Diabetes Res Clin Pract2004 63(3):213-223
Kerenyi Z, Samer H, James RE, et al. Improved Glycaemic Control in Individuals with Type 2 Diabetes When Treated with Rosiglitazone plus 7.5 mg Glibenclamide Compared to Increasing the Glibenclamide Dose to 15 mg. Diabetologia 2003; 46 (Suppl 2):A289.
Kerenyi Z, Samer H, James RE, et al. Rosiglitazone plus 7.5 mg Glibenclamide Improves Glycemia in Individuals with Type 2 Diabetes Compared to Increasing the glibenclamide dose to 15 mg. Diabetes 2003; 52 (Suppl 1):A449.
Medical condition
Diabetes Mellitus
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
September 2000 to May 2002
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
2002-10-05
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
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website