Clinical trial NCT00162175: PPAR-COMBO With Sulfonylurea
Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolics Diabetes Nos
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 534
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 Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes, HbA1c \> 7.0% and \< 10.0%, mean serum triglyceride \< 600 mg/dL, body mass index \< 41 kg/m2, fasting c-peptide . 1.5 ng/mL.

Exclusion Criteria:

* History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Primary outcomes:
measure: Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide
Secondary outcomes:
measure: Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24
Other outcomes:
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facility: Local Institution
state: Alabama
city: Hoover
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state: Alabama
city: Huntsville
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state: Alabama
city: Mobile
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state: Alabama
city: Mesa
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state: Arizona
city: Phoenix
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city: Tucson
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state: Arizona
city: Little Rock
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city: Encinitas
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state: California
city: Long Beach
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state: California
city: Los Angeles
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city: Denver
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city: Wheat Ridge
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city: Miami
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city: New Port Richey
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country: Russian Federation
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city: St. Petersburg
country: Russian Federation
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city: Santiago
country: Spain
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state: de Compostela
city: Las Palmas
country: Spain
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state: DE
city: A Coruna
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country: United Kingdom
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state: Cambridgeshire
city: Bexhill-on-Sea
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city: Sunbury on Thames
country: United Kingdom
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city: Aldershot
country: United Kingdom
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state: Hampshire
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Blackpool
country: United Kingdom
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state: Lancashire
city: Harrow
country: United Kingdom
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state: Middlesex
city: Hastings
country: United Kingdom
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state: Sussex
city: Bath
country: United Kingdom
facility: Local Institution
state: Wiltshire
city: Inkberrow
country: United Kingdom
facility: Local Institution
state: Worcestershire
city: Swan Lane
country: United Kingdom
facility: Local Institution
Study officials:
References:
citation: Rubin CJ, De Pril V, Fiedorek FT. Coadministration of muraglitazar plus glyburide: improvement of glycaemic and lipid profiles in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Apr;6(2):120-32. doi: 10.1177/1479164109336049.