Last updated: 11/07/2018 14:39:39
A 26-week Randomized, Double-blind, Multicenter, Placebo-Controlled, Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy When Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM) Using a Once Daily Dosing Regimen, and to Determine the Therap ...
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, Placebo-Controlled, Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy When Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM) Using a Once Daily Dosing Regimen, and to Determine the Therap ...
Trial description: A 26-week Randomized, Double-blind, Multicenter, Placebo-Controlled, Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy When Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM) Using a Once Daily Dosing Regimen, and to Determine the Therap ...
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.
Cranmer H, Jones NP, Patwardhan R. Rosiglitazone is effective in both obese and non-obese patients with type 2 diabetes. Diabetologia 1999; 42 (Suppl 1):A230. Abs 865 presented at EASD 1999.
Freed MI, Weston WM, Viberti G. Rosiglitazone (RSG) monotherapy reduces urinary albumin excretion in type 2 diabetes (T2DM). Diabetologia 1999; 42 (Suppl 1):A230. Abs 866 presented at EASD 1999.
Goldstein B, Salzman A. Rosiglitazone is effective in poorly controlled type 2 diabetes patients. Diabetologia 1999; 42 (Suppl 1):A229. Abs 861 presented at EASD 1999.
Grunberger G, Dole JF, Freed MI. Rosiglitazone monotherapy significantly lowers HbA1c levels in treatment-nave type 2 diabetic patients. Diabetes 2000; 49 (Suppl 1):A109. Abs 441 presented at ADA 2000.
Grunberger G, Weston WM, Patwardhan R et al. Rosiglitazone once or twice daily improves glycemic control in patients with type 2 diabetes. Diabetes 1999; 48 (Suppl 1):A102. Abs 0439 + poster presented at ADA 1999.
Grunberger G, Weston WM, Patwardhan R et al. Rosiglitazone once or twice daily improves glycemic control in patients with type 2 diabetes. Diabetologia 1999; 42 (Suppl 1):A4. Abs 8 presented at EASD 1999.
Once- and twice-daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes. Phillips, L. S., Grunberger, G., Miller, E., Patwardhan, R., Rappaport, E. B., and Salzman, A. Diabetes Care 2001; 24(2):308-15
Osei K, Miller EE, Everitt DE, Ilgenfritz J, Porter LE, Freed MI. Rosiglitazone is effective and well tolerated as monotherapy in African Americans with type 2 diabetes. Diabetes 2001; 50 (Suppl 2):A127. Abs 512-P presented at ADA 2001
Phillips LS, Grunberger G, Miller E et al. Once- and twice- daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes. Diabetes Care 2001; 24:308-315. Erratum: Diabetes Care 2001; 24:973.
Rebuck AS, Weill S, Patwardhan R. Rosiglitazone given once or twice daily is effective first-line treatment for type 2 diabetes mellitus. Diabetologia 1999; 42 (Suppl 1):A231. Abs 837 + poster presented at EASD 1999.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
December 1996 to February 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
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
1998-15-02
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
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