Clinical trial NCT00095030: Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone
Official title: A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Subjects Wtih Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2004-11-01
Enrollment: 1752
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: The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening
* HbA1c \>or = 7% and \< or = 10%
* Fasting c-peptide \> or = 1.0 umol
* Body Mass Index \< or = 41 kg/m2
* Mean serum triglycerides \< or = 600 mg/dl

Primary outcomes:
measure: Change in baseline HbA1c after 52 weeks
Secondary outcomes:
measure: Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks
Other outcomes:
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country: Russian Federation
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city: Bangkok
country: Thailand
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Study officials:
References:
citation: Rubin CJ, Ledeine JM, Fiedorek FT. Improvement of glycaemic and lipid profiles with muraglitazar plus metformin in patients with type 2 diabetes: an active-control trial with glimepiride. Diab Vasc Dis Res. 2008 Sep;5(3):168-76. doi: 10.3132/dvdr.2008.028.