Last updated: 11/07/2018 14:42:23
A 26-week Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BRL 49653C When Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Who Are Inadequately…
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 26-week Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BRL 49653C When Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Who Are Inadequately…
Trial description: A 26-week Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BRL 49653C When Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Who Are Inadequately…
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: Collegeville, Pennsylvania Philadelphia, PA; USA 6/22/2001
Abstract: Collegeville, Pennsylvania San Francisco, CA; USA 6/14/2002
Efficacy and safety of rosiglitazone plus metformin in mexicans with type 2 diabetes. Gomez-Perez, F. J., Fanghanel-Salmon, G., Antonio Barbosa, J., Montes-Villarreal, J., Berry, R. A., Warsi, G., and Gould, E. M. Diabetes Metab Res Rev 2002; 18(2):127-34
Gomez-Perez FJ et al. Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes. Diabetes Metab Res Rev 2002; 18:127-134
Gomez-Perez FJ, Fanghanel-Salmon G, Barbosa JA et al. Rosiglitazone-metformin combination therapy improves glycemic control in Mexican patients with type 2 diabetes.Diabetes 2001; 50 (Suppl 2):A436. Abs 1818-PO presented at ADA 2001.
Gould EM, Cobitz A. Improved glycemic control and no weight gain in Mexican patients treated with rosiglitazone 4 mg/day in combination with metformin. Diabetes 2002; 51 (Suppl 2). Abs 400-P + poster presented at ADA 2002.
Maheux P, Berry RA, Warsi G et al. Rosiglitazone-metformin combination improves glycaemic control in patients with type 2 diabetes. Can J Diabetes Care 2001; 25 (3). Poster #168 presented at 5th Annual CDA/CSEM Professional Conference 2001.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
January 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
1999-22-12
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
Not applicable
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