Clinical trial NCT00240383: Dose Ranging Study With LT, Monotherapy, PPAR
Official title: A Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus II
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 1260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes


Eligibility criteria: Inclusion Criteria:

* 1. HbA1c \> 7.0% and ≤ 10.0% obtained at the Screening visit.
* 2. Men and women, 18-70 years of age Established Type 2 diabetes

Exclusion Criteria:

* 1. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
* 2. Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening.
* 3. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.

Primary outcomes:
measure: To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2
Secondary outcomes:
measure: To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol
Other outcomes:
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city: Edinburgh
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city: Lanarkshire
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city: East Horsley
country: United Kingdom
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city: Cookstown
country: United Kingdom
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city: Atherstone
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state: Warwickshire
city: Balsall Common
country: United Kingdom
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state: Warwickshire
city: Stratford Upon Avon
country: United Kingdom
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city: Chelmsley wod
country: United Kingdom
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state: West Midlands
city: Chippenham
country: United Kingdom
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state: Wiltshire
city: Glasgow
country: United Kingdom
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Study officials:
References:
citation: Rubin CJ, Viraswami-Appanna K, Fiedorek FT. Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Jul;6(3):205-15. doi: 10.1177/1479164109336048.