CompletedPhase 1

Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

Lead sponsor

Bristol-Myers Squibb

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 6-10%

Primary endpoint

•Treatment-emergent AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00508287

Org study IDMB110-005

Timeline

Milestones

Study first posted2007-07-27estimated

Last update posted2009-03-16estimated

Study start2007-08 (month precision)

Primary completion2007-11actual (month precision)

Study completion2007-11actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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 ULN and total bilirubin ≤ 2 x ULN

•Stable and well controlled hypertension and/or dyslipidemia

•Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks

Exclusion criteria

•Women of childbearing potential

•Symptomatic diabetes with polyuria and/or polydipsia

•History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome

•History of renal disease including diabetic nephropathy

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint/low confidence

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

Time frame:from pre-dose to 9 hrs post-dose

Postprandial glucose

concentration, descriptive

componentsPostprandial glucose, Fasting glucose, change, C-peptide AUC

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Safety: incidence of adverse events

Time frame:from subject enrollment to study discharge

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF

Time frame:from pre-dose to 24 hrs post-dose

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.