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BMS-770767

Phase 2

Diabetes Type 2 | Small molecule | Metabolic |Bristol-Myers Squibb Company|Trials Updated: Oct 12, 2015

BMS-770767 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Jan 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment157

FDA Designations

No designations recorded

BMS-770767 clinical trials

BMS-770767 · 2 trials · 2 indications

Phase 2 2
NCT01046422Safety Study of BMS-770767 in Subjects With Type 2 DiabetesDiabetes Type 2
COMPLETED76 Analytics
NCT01058083Safety Study of BMS-770767 in Subjects With HypercholesterolemiaDyslipidemia
COMPLETED81 Analytics
PHASE2COMPLETED
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
Diabetes Type 2Unlock trial analytics
PHASE2COMPLETED
Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Fasting Plasma Glucose Improvement
Within seven days following dosing
Lowering of LDL-C
Within 28 days following dosing

Secondary Endpoints

Mean daily glucose (3-day 7 pt-fingerstick)
Within 28 days following dosing
Four (4)-hour post-prandial glucose AUC
Within 28 days following dosing
HbA1C
Within 28 days following dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-770767 ± metformin (Treatment A)EXPERIMENTAL -
BMS-770767 ± metformin (Treatment B)EXPERIMENTAL -
BMS-770767 ± metformin (Treatment C)EXPERIMENTAL -
BMS-770767 ± metformin (Treatment D)EXPERIMENTAL -
Placebo ± metformin (Treatment E)PLACEBO_COMPARATOR -
BMS-770767 (Treatment A)EXPERIMENTAL -
BMS-770767 (Treatment B)EXPERIMENTAL -
BMS-770767 (Treatment C)EXPERIMENTAL -
BMS-770767 (Treatment D)EXPERIMENTAL -
Placebo (Treatment E)PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BMS-770767DRUGCapsule, Oral, 15mg, Active, Daily, 28 days
PlaceboDRUGCapsule, Oral, 0mg, Daily, 28 days
MetforminDRUGTablet, Oral, ≥ 1500mg, Active, Daily, 28 days
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Diagnosed with type 2 diabetes with inadequate glycemic control and treated with either diet and exercise alone, or with stable doses (≥ 1500mg/d) of metformin for at least 8 weeks prior to screening * HbA1c ≥ 7.0% and ≤ 10.0% with FPG ≤ 240mg/dL (13.3 mmol/dL) Exclusion Crit...

Countries:United StatesAustraliaCanadaSouth Korea
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Competitive Landscape -Diabetes Complications 8 trials (matched to "Diabetes Type 2")

No competing companies are currently tracked in active development for Diabetes Complications.
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Frequently asked questions about BMS-770767

What is BMS-770767 used for?

BMS-770767 is an investigational small molecule being developed for Type 2 diabetes and dyslipidemia. It has been studied in Phase 2 clinical trials for these metabolic conditions. The drug is not approved and remains in clinical development.

Who makes BMS-770767?

BMS-770767 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has conducted clinical trials of this investigational drug for metabolic indications.

What phase is BMS-770767 in?

BMS-770767 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in Type 2 diabetes and one in dyslipidemia. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BMS-770767 in?

BMS-770767 has been studied in two completed Phase 2 trials. NCT01046422 evaluated the drug in subjects with Type 2 diabetes, enrolling 76 participants. NCT01058083 evaluated it in subjects with hypercholesterolemia, enrolling 81 participants. Both trials were randomized, double-blind, and placebo-controlled.

Is BMS-770767 FDA approved?

BMS-770767 is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for Type 2 diabetes and dyslipidemia. The drug remains in clinical development and has not been authorized for marketing.