Safety Study of BMS-823778 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-823778 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

NCT01111955

Enrollment

Registered

2010-04-28

Start date

2010-07-31

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 Mellitus, Type 2

Brief summary

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).

Interventions

DRUGBMS-823778

Capsules, Oral, 2 mg, once daily, 28 days

DRUGPlacebo

Capsules, Oral, 0 mg, once daily, 28 days

DRUGMetformin

Capsules, Oral, ≥ 1500 mg, once daily, 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes mellitus * Drug naive or on stable metformin therapy * HbA1c 7-10% * FPG ≤ 240mg/dL

Exclusion criteria

* History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study * Congestive heart failure * Active liver disease * Impaired renal function * Hepatitis C, B and HIV This list is not inclusive; additional information is provided in the protocol

Design outcomes

Primary

Measure	Time frame
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline	Within 28 days following dosing

Secondary

Measure	Time frame
Pharmacokinetics (measuring trough concentrations)	On days 7, 14 and 28
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)	Within 28 days following dosing

Countries

Australia, Canada, United States

Outcome results

None listed

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