Last updated: 11/07/2018 14:38:55
A Multicentre, Double-Blind, Placebo Controlled, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone with Concurrent Sulphonylurea therapy, When Administered to Patients with Type 2 Diabetes Mellitus.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multicentre, Double-Blind, Placebo Controlled, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone with Concurrent Sulphonylurea therapy, When Administered to Patients with Type 2 Diabetes Mellitus.
Trial description: A Multicentre, Double-Blind, Placebo Controlled, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone with Concurrent Sulphonylurea therapy, When Administered to Patients with Type 2 Diabetes Mellitus.
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.
Combination therapy for type 2 diabetes: repaglinide plus rosiglitazone. Raskin, P., McGill, J., Saad, M. F., Cappleman, J. M., Kaye, W., Khutoryansky, N., and Hale, P. M. Diabet Med 2004; 21(4):329-35
Gomis R, Jones NP, Vallance SE et al. Low-dose rosiglitazone (RSG) provides additional glycemic control when combined with sulfonylureas in type 2 diabetes. Diabetes 1999; 48 (Suppl 1):A63. Abs 266. Poster presented at ADA 1999.
Gomis R, Jones NP, Vallance SE et al. Low-dose rosiglitazone enhances glycemic control when combined with sulfonylureas in type 2 diabetes. Diabetologia 1999; 42 (Suppl 1):A851. Poster presented at EASD 1999.
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. Abs 858 presented at EASD 1999.
Owen S, Jones NP, Patwardhan R. Rosiglitazone treatment reduces gamma-glutamyltransferase levels, a marker for visceral and hepatic fat. Diabetes 2000; 49 (Suppl 1):A120. Abs 488 + poster presented at ADA 2000.
Wolffenbuttel BH, Gomis R, Squatrito S et al. Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in Type 2 diabetic patients. Diabetic Med 2000; 17:40-47.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
July 1996 to March 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
1998-03-03
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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