Last updated: 11/07/2018 14:38:22
A 26-Week Randomized, Double-blind, Multicenter, Placebo-Controlled, Comparison Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy when Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM)
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, Comparison Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy when Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM)
Trial description: A 26-Week Randomized, Double-blind, Multicenter, Placebo-Controlled, Comparison Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy when Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM)
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: 11/7/2004. RMIS 1) Univ of Washington, Seattle, WA; 2) State Univ of New York, New York, NY; 3) GlaxoSmithKline, King of Prussia, PA; 4) GlaxoSmithKline, King of Prussia, SD New Orleans, LA; USA
Abstract: 6/22/2001. RMIS Brooklyn, New York Philadelphia, PA; USA
Abstract: 6/4/2004. RMIS Brooklyn, NY; King of Prussia, PA; Seattle, WA Orlando, FL; USA
Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999; 57: 921930.
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 and poster presented at EASD 1999.
Evaluation of liver function in type 2 diabetic patients during clinical trials: evidence that rosiglitazone does not cause hepatic dysfunction. Lebovitz, H. E., Kreider, M., and Freed, M. I. Diabetes Care 2002; 25(5):815-21
Freed MI, Weston WM, Viberti G. Rosiglitazone (RSG) monotherapy reduces urinary albumin excretion in type 2 diabetes (T2DM). Diabetologia 1999; 42 (Suppl. 1):A230 and poster presented at EASD 1999.
Goldstein B, Salzman A. Rosiglitazone is effective in poorly controlled type 2 diabetes patients. Diabetologia 1999; 42 (Suppl. 1):A229 and poster presented at EASD 1999.
Grunberger G, Dole JF, Freed MI et al. Rosiglitazone monotherapy significantly lowers HbA1c levels in treatment-nave type 2 diabetic patients. Diabetes 2000; 49 (Suppl. 1):A109 and poster presented at ADA 2000.
Kahn S, Porter L, Freed M et al. Rosiglitazone improves beta-cell function as measured by proinsulin/insulin ratio in patients with type 2 diabetes. Diabetes Res Clin Pract 2000; 50 (Suppl. 1):S6263 and poster P305 presented at IDF 2000.
Lebovitz HE, Dole JF, Patwardhan R et al. Rosiglitazone monotherapy is effective in patients with type 2 diabetes. J Clin Endocrinol Metab 2001; 86:280288. Erratum: J Clin Endocrinol Metab 2001; 86:1659.
Lebovitz HE, Patel J, Dole J et al. Rosiglitazone (BRL49653) monotherapy has significant glucose lowering effect in type 2 diabetic patients. Diabetologia 1998; 41 (Suppl. 1):A238 and poster presented at EASD 1998.
Matthews DR, Bakst A, Weston WM et al. Rosiglitazone decreases insulin resistance and improves beta-cell function in patients with type 2 diabetes. Diabetologia 1999; 42 (Suppl. 1):A229 and poster presented at EASD 1999.
Osei K, Miller EE, Everitt DE et al. Rosiglitazone is effective and well tolerated as monotherapy in African Americans with type 2 diabetes. Diabetes 2001; 50 (Suppl. 2):A127 and poster presented at ADA 2001.
Patel J, Miller E. Patwardhan R et al. Rosiglitazone (BRL49653) monotherapy has significant glucose lowering effect in type 2 diabetic patients. Diabetes 1998; 47 (Suppl. 1):A17.
Porter L. Rosiglitazone reduces proinsulin:insulin ratio and improves -cell function in type 2 diabetes. Submitted to Endocrine Practice. Awaiting peer-review comments, Mar 2003.
Porter LE, Freed MI, Jones NP et al. Rosiglitazone improves beta-cell function as measured by proinuslin/insulin ratio in patients with type 2 diabetes. Diabetes 2000; 49 (Suppl. 1):A122 and poster presented at ADA 2000.
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 and poster presented at EASD 1999.
Rosiglitazone monotherapy is effective in patients with type 2 diabetes. Lebovitz, H. E., Dole, J. F., Patwardhan, R., Rappaport, E. B., and Freed, M. I. J Clin Endocrinol Metab 2001; 86(1):280-8
Weston WM, Heise MA, Porter LE et al. Rosiglitazone-mediated reductions in urinary albumin excretion are associated with changes in ambulatory blood pressure in type 2 diabetes patients. Diabetes 2001; 50 (Suppl 2):A541 and poster presented at ADA 2001.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
July 1996 to September 1997
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
1997-29-09
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
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