Last updated: 11/07/2018 14:45:50
A 3 Year Open-label, Multicenter, Active (Glyburide) Comparison Study to Evaluate the Effect of Rosiglitazone on Cardiovascular Function in 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 3 Year Open-label, Multicenter, Active (Glyburide) Comparison Study to Evaluate the Effect of Rosiglitazone on Cardiovascular Function in Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM)
Trial description: A 3 Year Open-label, Multicenter, Active (Glyburide) Comparison Study to Evaluate the Effect of Rosiglitazone on Cardiovascular Function in 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:
Bakris G, Viberti G, Weston WM et al. Rosiglitazone reduces urinary albumin excretion in type 2 diabetes. J Hum Hypertens 2003; 17:7-12.
Bakris G, Weston WM, Rappaport EB et al. Rosiglitazone produces long-term reductions in urinary albumin excretion in type 2 diabetes. Diabetologia 1999; 42 (Suppl 1):A230. Abs 685 + poster presented at EASD 1999.
Bakris GL, Dole JF, Porter LE et al. Rosiglitazone improves blood pressure in patients with type 2 diabetes mellitus. Diabetes 2000; 49 (Suppl 1):A96. Abs 388 presented at ADA 2000.
Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999; 57:921-930.
Cobitz A, Deacon L, Stewart M. Rosiglitazone: effects on the insulin resistance metabolic syndrome. Can J Diabetes Care 2001; 25 (3) and poster 170 presented at the 5th Annual CDA/CSEM Professional Conference 2001.
Garber A, Cobitz AR, Deacon L et al. Rosiglitazone: effects on the insulin resistance metabolic syndrome. Published in ENDO 2001 congress book. Abs 36051; poster P3-61.
Murphy K & Salzman A. Rosiglitazone is superior to glyburide in establishing long-term glycemic control in patients with type 2 diabetes. Abstract and poster 1827 presented at the Endocrine Society 82nd Annual Meeting. Toronto, Canada; 21.24 June 2000.
Rendell M, Dole J, et al. Rosiglitazone improves glycaemic control without adversely affecting cardiac function in type 2 diabetes. Diabetologia 1999, 42 (Suppl 1):A242 and poster presented at EASD 1999.
Salzman A & Murphy K. Rosiglitazone: cardiac safety with long-term treatment in patients with type 2 diabetes. Diabetes Res Clin Pract 2000, 50 (Suppl 1):S64 and poster presented at IDF 2000.
St John Sutton M, Dole J & Rappaport E. Rosiglitazone does not adversely affect cardiac structure or function in patients with type 2 diabetes. Diabetes 1999; 48 (Suppl 1):A102. Abs 0438 and poster presented at ADA 1999.
St John Sutton M, Rendell M, Dandona P et al. A comparison of the effects of rosiglitazone and glyburide on cardiovascular function and glycemic control in patients with Type 2 diabetes mellitus. Diabetes Care 2002; 25:2058-2064.
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). Abs 541-P presented at ADA 2001.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
September 1996 to June 2000
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
2000-02-06
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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