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Muraglitazar

Phase 3

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

Success Probability

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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 MellitusUnlock trial analytics
PHASE3COMPLETED
Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics
Type 2 DiabetesUnlock trial analytics
PHASE3COMPLETED
PPAR-COMBO With Sulfonylurea
Metabolics Diabetes NosUnlock trial analytics
PHASE3COMPLETED
PPAR - Combination With Metformin
Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Diabetes, Type 2Unlock trial analytics

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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Frequently asked questions about Muraglitazar

What is Muraglitazar used for?

Muraglitazar is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus and related metabolic diabetes conditions. It was studied in Phase 3 clinical trials as a potential therapy for patients with Type 2 Diabetes, including in combination with other antidiabetic medications.

What does Muraglitazar target?

Muraglitazar is a dual peroxisome proliferator-activated receptor (PPAR) agonist, targeting both PPAR-alpha and PPAR-gamma. This mechanism is designed to improve glycemic control and lipid metabolism in patients with Type 2 Diabetes Mellitus.

Who makes Muraglitazar?

Muraglitazar is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the New York Stock Exchange. The company conducted Phase 3 clinical trials to evaluate the drug's safety and efficacy in treating Type 2 Diabetes.

What phase is Muraglitazar in?

Muraglitazar is in Phase 3 clinical development. It has completed multiple Phase 3 trials, but it remains an investigational drug and is not approved by regulatory authorities. The completed trials studied its use in Type 2 Diabetes Mellitus, both as monotherapy and in combination with other treatments.

What clinical trials is Muraglitazar in?

Muraglitazar has completed four Phase 3 clinical trials. These include NCT00106808 comparing it to pioglitazone, NCT00162175 combining it with sulfonylurea, NCT00162240 combining it with metformin, and NCT00240370 evaluating metformin combined with muraglitazar or pioglitazone. All trials were completed with a total enrollment of 1,794 patients.

Is Muraglitazar the same as pioglitazone?

No, Muraglitazar is not the same as pioglitazone. Pioglitazone is a separate PPAR-gamma agonist used as an active comparator in clinical trials. Muraglitazar is a distinct dual PPAR-alpha and PPAR-gamma agonist developed by Bristol-Myers Squibb, and it was studied against pioglitazone in the Phase 3 trial NCT00106808.