Last updated: 11/07/2018 14:46:54
A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5 mg/day) ...
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5 mg/day) ...
Trial description: A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5 mg/day) ...
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.
Fonseca V, Biswas N, Patwardhan R et al. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus. JAMA 2000; 283:1695.1702.
Fonseca V, Biswas N, Salzman A. Once daily rosiglitazone in combination with metformin effectively reduces hyperglycemia in patients with type 2 diabetes. Diabetes 1999; 48 (Suppl 1):A100. Abstract presented at ADA 1999.
Fonseca V, Biswas N, Salzman A. Rosiglitazone in combination with metformin effectively reduces hyperglycemia in patients with type 2 diabetes. Diabetologia 1999; 42 (Suppl 1):A864. Abstract + poster presented at EASD 1999.
Jones NP, Mather R, Owen S et al. Long-term efficacy of rosiglitazone as monotherapy or in combination with metformin. Diabetologia 2000; 43 (Suppl 1):A192. Abs and poster 736 presented at EASD 2000.
Jones TA, Sautter M, Van Gaal, LF et al. Addition of rosiglitazone to metformin is effective in obese, insulin-resistant patients with type 2 diabetes. Diabetes, Obes & Metab2003;5:163-170
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.
Patwardhan R, Porter LE, Jones NP. Long-term efficacy of rosiglitazone as monotherapy or combination therapy in patients with type 2 diabetes mellitus. Abstract 1826 and poster presented at the US Endocrine Society Meeting, June 2000.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
March 1997 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
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
1998-13-03
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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