Last updated: 11/07/2018 14:37:37
A 12-Week, Multicenter, Double-Blind, Placebo-Controlled, Dose Response Study Assessing the Safety, Tolerability, and Efficacy of BRL 49653C in Subjects with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
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 12-Week, Multicenter, Double-Blind, Placebo-Controlled, Dose Response Study Assessing the Safety, Tolerability, and Efficacy of BRL 49653C in Subjects with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
Trial description: A 12-Week, Multicenter, Double-Blind, Placebo-Controlled, Dose Response Study Assessing the Safety, Tolerability, and Efficacy of BRL 49653C in Subjects 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:
Abstract: BRL 49653 (A Thiazolidinedione) is Well Tolerated and Has No Effect on LV Mass Following 12 Weeks Treatment in NIDDM Patients, Miller, E, MD; Patel, J, MD; Reichek, N, MD; Granett, J, MD. Boston, MA; USA. American Diabetes Association 57th Annual Meeting and Scientific Sessions. 6/21/1997
Balfour JA, Plosker GL. Rosiglitazone Drugs 1999; 57:921-930
Miller E, Patel J, Reichek N, et al. BRL 49653 (a thiazolidinedione) is well tolerated and has no effect on LV mass following 12 weeks treatment in NIDDM patients. Diabetes 1997; 46 (Suppl 1): 96A.
Patel J, Anderson RJ, Rappaport EB. Rosiglitazone monotherapy improves glycaemic control in patients with type 2 diabetes: a twelve-week, randomized, placebo-controlled study. Diabetes Obes Metab 1999; 1: 165-172.
Patel J, Miller E, Hu J, et al. BRL 49653 (a thiazolidinedione) improves glycemic control in NIDDM patients. Diabetes 1997; 46 (Suppl 1): 150A.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
February 1995 to February 1996
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
1996-10-02
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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