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BMS-686117

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Mar 16, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

BMS-686117 · 1 trial · 1 indication

Phase 1 1
NCT00508287Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 DiabetesType 2 Diabetes
COMPLETED36 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: incidence of adverse events
from subject enrollment to study discharge

Secondary Endpoints

PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF
from pre-dose to 24 hrs post-dose
PD Measures: Fasting and postprandial serum glucose (AUC), serum insulin, and plasma glucagon concentrations. Acetaminophen plasma concentrations will be measured after a single dose of acetaminophen
from pre-dose to 9 hrs post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
CPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BMS-686117DRUGInjection solution, Subcutaneous, 1 mg, Once daily, Single dose.
ByettaDRUGInjection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
PlaceboDRUGInjection solution, Subcutaneous, 1 mg, Once daily, Single dose.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve) * Fasting plasma glucose: 126 - 240 mg/dL * Hemoglobin A1c: 6 - 10% * Estimated CrCl ≥ 60 mL/min * ALT ≤ 1.5 x ...

Countries:United States
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Frequently asked questions about BMS-686117

What is BMS-686117 used for?

BMS-686117 is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is a metabolic therapeutic that has been studied in a Phase 1 clinical trial to evaluate its safety, pharmacokinetics, and pharmacodynamics in subjects with the condition.

Who makes BMS-686117?

BMS-686117 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company conducted a Phase 1 clinical trial of the drug in the United States.

What phase is BMS-686117 in?

BMS-686117 is in Phase 1 of clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is BMS-686117 in?

BMS-686117 has been studied in one completed Phase 1 trial, identified as NCT00508287. This randomized, double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of the drug in 36 subjects with Type 2 Diabetes in the United States.

Is BMS-686117 the same as any other drug?

No alternative names for BMS-686117 have been identified. The drug is known by its development code, BMS-686117, and is being studied by Bristol-Myers Squibb for Type 2 Diabetes.