Last updated: 11/07/2018 14:48:52
2-year, Randomized, Double-blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled on Glipizide Therapy
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 2-year, Randomized, Double-blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled on Glipizide Therapy
Trial description: 2-year, Randomized, Double-blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled on Glipizide Therapy
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:
Rosenstock J, et al. Type 2 diabetes in the elderly: reaching durable glycemic goals with combination sulfonylurea and rosiglitazone. Diabetes Metab 2003; 29:4S247 4S248. Poster 2278 presented at IDF.
Vinik AI, et al. Long-term effect of rosiglitazone on pancreatic beta cell function and insulin resistance in older type 2 diabetes mellitus patients treated with sulfonylurea. Diabetes 2004;53(Suppl 2):A162. Poster 680 presented at ADA
Weston WM et al. Rosiglitazone added early to sulfonylurea provides superior control vs. uptitration of sulfonylurea. Diabetes 2004;53(Suppl 2):A151. Poster 635 presented at ADA
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
February 1999 to September 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
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-30-09
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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