Safety Study of BMS-770767 in Subjects With Type 2 Diabetes

A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01046422

Enrollment

Registered

2010-01-12

Start date

2010-05-31

Completion date

2011-01-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

Brief summary

The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population

Interventions

DRUGBMS-770767

Capsule, Oral, 15mg, Active, Daily, 28 days

DRUGPlacebo

Capsule, Oral, 0mg, Daily, 28 days

DRUGMetformin

Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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 criteria

* Women of childbearing potential * History of diabetic ketoacidosis or hyperosmolar nonketotic coma * Significant cardiovascular history * History of unstable or rapidly progressing renal disease * Impaired renal function defined by a serum creatinine \> 1.4mg/dL (124 µmol/L) for women and \>1.5mg/dL (133 µmol/L) for men * Active liver disease and /or significant abnormal liver function defined as AST \> 3X ULN and/or ALT \> 3XULN and /or serum total bilirubin \> 2.0mg/dl

Design outcomes

Primary

Measure	Time frame
Fasting Plasma Glucose Improvement	Within seven days following dosing

Secondary

Measure	Time frame
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
Lipid profiles	Within 28 days following dosing

Countries

Australia, Canada, South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026