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BMS-512148

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Oct 27, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

BMS-512148 · 1 trial · 1 indication

Phase 2 1
NCT00162305A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic SubjectsDiabetes Mellitus, Type 2
COMPLETED47 Analytics
PHASE2COMPLETED
A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
Diabetes Mellitus, Type 2
NCT0016230547
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Study Endpoints

Primary Endpoints

To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects
14 days

Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

Secondary Endpoints

To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin
14 days
To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis
14 days
To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BMS-512148DRUGCapsules, Oral, 100 mg, Once daily, 14 days.
PlaceboDRUGCapsules, Oral, 0 mg, Once daily, 14 days.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive). * Fasting glucose (FG) \< - 240 mg/dL, while on metformin or antidiabetic diet alone. * HbA1c (Hemoglobin A1c) in the range of 6.0-10.0% Exclusion Criteria: * Women ...

Countries:United States
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Frequently asked questions about BMS-512148

What is BMS-512148 used for?

BMS-512148 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, exposure, and biological effects in patients with stable Type 2 diabetes.

Who makes BMS-512148?

BMS-512148 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical trials for the treatment of Type 2 Diabetes Mellitus.

What phase is BMS-512148 in?

BMS-512148 is in Phase 2 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not yet been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 2 trial to assess its safety and biological effects.

What clinical trials is BMS-512148 in?

BMS-512148 has one completed clinical trial registered under NCT00162305, titled 'A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects.' This Phase 2 trial enrolled 47 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is BMS-512148 FDA approved?

No, BMS-512148 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug has completed one Phase 2 trial, but it has not yet received regulatory approval for any indication.