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BMS-820132

Phase 1

Diabetes Mellitus, Non-Insulin-Dependent | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Mar 27, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

BMS-820132 · 2 trials · 2 indications

Phase 1 2
NCT01290575Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 DiabetesType 2 Diabetes
COMPLETED67 Analytics
NCT01105429Single Ascending Dose Study of BMS-820132 in Patients With Type 2 DiabetesDiabetes Mellitus, Non-Insulin-Dependent
COMPLETED56 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
Diabetes Mellitus, Non-Insulin-DependentUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Throughout the study drug administration period (14 days)
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Within 5 days of study drug administration

Secondary Endpoints

Maximum observed plasma concentration (Cmax) of BMS-820132
Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-820132
Day 1 and Day 14
Trough observed plasma concentration (Cmin) of BMS-820132
Day 1 through Day 14 (selected days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 2 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 3 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 4 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 5 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 6 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 7 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 8 BMS-820132 or placeboACTIVE_COMPARATOR -
Arm 9 BMS-820132 or placeboACTIVE_COMPARATOR -
BMS-820132 (0.3 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (1.0 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (3 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (10 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (30 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (75 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (150 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (300 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (TBD) or PlaceboACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGcapsule, Oral, 0.0mg, twice daily, 14 day
BMS-820132DRUGCapsule, Oral, 15mg, twice daily, 14 day
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile). * Diagnosis of type 2 diabetes treated with metformin monotherapy (at least 1500 mg/day f...

Countries:United States
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Frequently asked questions about BMS-820132

What is BMS-820132 used for?

BMS-820132 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus, also referred to as Non-Insulin-Dependent Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BMS-820132?

BMS-820132 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials of this investigational drug in patients with Type 2 Diabetes.

What phase is BMS-820132 in?

BMS-820132 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. Two Phase 1 studies have been completed, and the drug remains under evaluation for safety and tolerability in patients with Type 2 Diabetes.

What clinical trials is BMS-820132 in?

BMS-820132 has been studied in two completed Phase 1 clinical trials. NCT01105429 was a single ascending dose study in 56 patients with Type 2 Diabetes, and NCT01290575 was a multiple ascending dose study in 67 patients with Type 2 Diabetes. Both trials were conducted in the United States.

Is BMS-820132 the same as any other drug?

No alternative names for BMS-820132 have been disclosed. The drug is identified solely by its compound code BMS-820132 in clinical trial registrations and development records.