Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BMS-823778; Drug: Placebo; Drug: Metformin

• Registration Number: NCT01111955
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2010-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2012-04-25
• Status Verified: 2015-09
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-823778 (20 mg)	BMS-823778	+ metformin
BMS-823778 (2 mg)	BMS-823778	+ metformin
BMS-823778 (20 mg)	Metformin	+ metformin
Placebo	Placebo	+ metformin
Placebo	Metformin	+ metformin
BMS-823778 (10 mg)	BMS-823778	+ metformin
BMS-823778 (2 mg)	Metformin	+ metformin
BMS-823778 (10 mg)	Metformin	+ metformin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Capital Clinical Reserch Center; 🇺🇸 Olympia, Washington, United States

Farid Marquez, Md; 🇺🇸 Hialeah, Florida, United States

Local Institution; 🇨🇦 Quebec, Canada

Aurora Advanced Healthcare; 🇺🇸 Milwaukee, Wisconsin, United States