Last updated: 11/07/2018 14:46:31

An 8-week Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Rosiglitazone (BRL 49653) Therapy when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Using a Twice Daily D ...

GSK study ID
49653/090
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An 8-week Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Rosiglitazone (BRL 49653) Therapy when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Using a Twice Daily D ...
Trial description: An 8-week Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Rosiglitazone (BRL 49653) Therapy when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Using a Twice Daily D ...
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:
Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999; 57:921-930.
Raskin P, Rappaport EB, Cole ST, et al. Rosiglitazone short term monotherapy lowers fasting and post-prandial glucose in patients with type II diabetes. Diabetologia 2000; 43:278-284.
Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with type II diabetes. Raskin, P., Rappaport, E. B., Cole, S. T., Yan, Y., Patwardhan, R., and Freed, M. I. Diabetologia 2000; 43(3):278-84
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
April 1997 to December 1997
Type
Not applicable
Phase
3

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

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
1997-23-12

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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An 8-week Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Rosiglitazone (BRL 49653) Therapy when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Using a Twice Daily D ..., Trial ID 49653%2F090 | GSK