Last updated: 11/07/2018 14:39:13
A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone vs. Glibenclamide Therapy, When Administered to Patients with Type 2 Diabetes Mellitus.
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 Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone vs. Glibenclamide Therapy, When Administered to Patients with Type 2 Diabetes Mellitus.
Trial description: A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone vs. Glibenclamide 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:
Abstract: Rosiglitazone is an Effective Alternative to Glibenclamide as First-Line Therapy in Type 2 Diabetic Patients, Owen, S; Charbonnel, B; Lonnqvist, F; Patwardhan, R. Harlow, UK; Nantes, France; Huddinge, Sweden; Collegeville, USA; Brighton; UK. British Diabetic Association Annual Professional Conference. 3/15/2000
Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999; 57:921-930.
Charbonnel B, Lonnqvist F, Jones NP et al. Rosiglitazone is superior to glyburide in reducing fasting plasma glucose after one year of treatment in type 2 diabetic patients. Diabetes 1999; 48 (Suppl 1):A114-115. Abs 4094 + poster presented at ADA 1999. Lonnqvist F, Charbonnel B, Jones NP et al. Rosiglitazone is superior to glyburide in reducing fasting plasma glucose in type 2 diabetic patients. Diabetologia 1999; 42 (Suppl 1):A231. Abs 869 presented at EASD 1999.
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.
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.
Jones NP, Charbonnel B, Lonnqvist F et al. Rosiglitazone reduces plasma insulin and its precursors while decreasing glycaemia in type 2 diabetics. Diabetologia 1999; 42 (Suppl 1):A229. Abs 859 presented at EASD 1999.
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). P305 presented at IDF 2000.
Lonnqvist F, Charbonnel B, Jones NP et al. Rosiglitazone is superior to glyburide in reducing fasting plasma glucose in type 2 diabetic patients. Diabetologia 1999; 42 (Suppl 1):A231. Abs 869 presented at EASD 1999.
Owen S, Charbonnel B, Lonnqvist F et al. Rosiglitazone is an effective alternative to glibenclamide as first-line therapy in type 2 diabetic patients. Diabetologia 1999; 42 (Suppl 1):A231. Abs 868 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.
Porter L. Rosiglitazone reduces proinsulin:insulin ratio and improves -cell function in type 2 diabetes. Submitted to Endocr Pract. Awaiting peer review comments, March 2003.
Porter LE, Freed MI, Jones NP et al. Rosiglitazone improves beta-cell function as measured by proinsulin/insulin ratio in patients with type 2 diabetes. Diabetes 2000; 49 (Suppl 1):A122. Abs 495 + 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. Abs 837 + poster presented at EASD 1999.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
July 1996 to May 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
1998-15-05
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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