Last updated: 11/07/2018 14:47:06
A Multicentre, Double-Blind, Parallel Group, Placebo-Controlled Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered Once Daily 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, Placebo-Controlled Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered Once Daily to Patients with Type 2 Diabetes Mellitus
Trial description: A Multicentre, Double-Blind, Parallel Group, Placebo-Controlled Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered Once Daily 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:
Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in type 2 diabetic patients. Wolffenbuttel, B. H., Gomis, R., Squatrito, S., Jones, N. P., and Patwardhan, R. N. Diabet Med 2000; 17(1):40-7
Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999; 57:921930.
Nolan JF, Jones NP, Patwardhan R, et al. Once-daily rosiglitazone is effective in the treatment of type 2 diabetes mellitus. Diabetes 1999; 48 (Supplement 1):A111.
Nolan JJ, Jones NP, Patwardhan R, et al. Rosiglitazone taken once daily provides effective glycaemic control in patients with Type 2 diabetes mellitus. Diabet Med 2000; 17:287294.
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 (Supplement 1):A231.
Owen S, Jones NP, Patwardhan R. Rosiglitazone treatment reduces gamma-glutamyltransferase levels, a marker for visceral and hepatic fat. Diabetes 2000; 49 (Supplement 1):A120.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
April 1997 to November 1997
Type
Not applicable
Phase
2
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
1997-21-11
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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