Last updated: 11/07/2018 14:46:08
A 26-Week Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of BRL 49653C when Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on Insulin Monotherapy
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 Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of BRL 49653C when Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on Insulin Monotherapy
Trial description: A 26-Week Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of BRL 49653C when Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on Insulin Monotherapy
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:
A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Raskin, P., Rendell, M., Riddle, M. C., Dole, J. F., Freed, M. I., and Rosenstock, J. Diabetes Care 2001; 24(7):1226-32
Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999; 57:921-930.
Raskin P, Dole JF, Rappaport EB. Rosiglitazone improves glycemic control in poorly controlled, insulin-treated type 2 diabetes (T2D). Diabetes 1999; 48 (Suppl. 1):A94. Abs 0404 + poster presented at ADA 1999.
Raskin P, Rendell M, Riddle MC et al. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care 2001; 24:12261232.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
June 1997 to August 1998
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
1998-25-08
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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