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Muraglitazar

Phase 3

Metabolics Diabetes Nos | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Apr 27, 2012

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment534
FDA Designations
No designations recorded
Clinical trial landscape

Muraglitazar · 9 trials · 8 indications

Phase 3 7Phase 2 2
NCT00106808Study of Muraglitazar Versus Pioglitazone in Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED1,440 Analytics
NCT00094991Mechanism of Action and Efficacy of Muraglitazar in Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED42 Analytics
NCT00095030Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin AloneDiabetes Mellitus, Type 2
COMPLETED1,752 Analytics
NCT00240370A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 DiabeticsType 2 Diabetes
COMPLETED1,159 Analytics
NCT00162175PPAR-COMBO With SulfonylureaMetabolics Diabetes Nos
COMPLETED534 Analytics
NCT00162240PPAR - Combination With MetforminDiabetes Mellitus
COMPLETED534 Analytics
NCT00246987A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic ControlDiabetes, Type 2
COMPLETED341 Analytics
PHASE3COMPLETED
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
Type 2 Diabetes Mellitus
NCT001068081,440
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PHASE3COMPLETED
Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes
Diabetes Mellitus, Type 2
NCT0009499142
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PHASE3COMPLETED
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone
Diabetes Mellitus, Type 2
NCT000950301,752
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PHASE3COMPLETED
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics
Type 2 Diabetes
NCT002403701,159
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PHASE3COMPLETED
PPAR-COMBO With Sulfonylurea
Metabolics Diabetes Nos
NCT00162175534
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PHASE3COMPLETED
PPAR - Combination With Metformin
Diabetes Mellitus
NCT00162240534
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PHASE3COMPLETED
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Diabetes, Type 2
NCT00246987341
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Study Endpoints
Primary Endpoints
Change in HBA1c from baseline to Week 24
The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar
Change in baseline HbA1c after 52 weeks
Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin
Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide
compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
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
To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg
Secondary Endpoints
Change for baseline in TG and HDL-C at Week 24
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MuraglitazarDRUG -
PioglitazoneDRUG -
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites195

Inclusion Criteria: * Type 2 Diabetes * HbA1c \> = 8.0% and \< = 12.0% * Serum triglyceride concentration \< = 600 mg/dL * Fasting c-peptide \> = 1.0 ng/ml * Body mass index \< = 41 kg/m2 * Drug naive patients Exclusion Criteria: * History of MI (myocardial infarction), coronary angioplasty or by...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileIndiaMexicoPeruPhilippinesRussiaTaiwanThailandUkraineItalyAustriaGermanyHong KongPolandPuerto RicoSwitzerlandFranceNetherlandsSpainUnited KingdomSouth KoreaSwedenCzechiaSouth Africa
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