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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BMS-823778

Placebo

Metformin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BMS-823778 (2 mg)

BMS-823778 (10 mg)

BMS-823778 (20 mg)

Placebo

Arm Description

+ metformin

Outcomes

Primary Outcome Measures

Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline

Secondary Outcome Measures

Pharmacokinetics (measuring trough concentrations)

Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)

Full Information

NCT ID

NCT01111955

First Posted

April 26, 2010

Last Updated

September 23, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01111955

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BMS-823778 (2 mg)

Arm Type

Active Comparator

Arm Description

+ metformin

Arm Title

BMS-823778 (10 mg)

Arm Type

Active Comparator

Arm Description

+ metformin

Arm Title

BMS-823778 (20 mg)

Arm Type

Active Comparator

Arm Description

+ metformin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

+ metformin

Intervention Type

Drug

Intervention Name(s)

BMS-823778

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

BMS-823778

Intervention Description

Capsules, Oral, 10 mg, once daily, 28 days

Intervention Type

Drug

Intervention Name(s)

BMS-823778

Intervention Description

Capsules, Oral, 20 mg, once daily, 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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

Primary Outcome Measure Information:

Title

Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline

Time Frame

Within 28 days following dosing

Secondary Outcome Measure Information:

Title

Pharmacokinetics (measuring trough concentrations)

Time Frame

On days 7, 14 and 28

Title

Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)

Time Frame

Within 28 days following dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Farid Marquez, Md

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Capital Clinical Reserch Center

City

Olympia

State/Province

Washington

ZIP/Postal Code

98502

Country

United States

Facility Name

Aurora Advanced Healthcare

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

Local Institution

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Local Institution

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Local Institution

City

Freemantle

State/Province

Western Australia

ZIP/Postal Code

6959

Country

Australia

Facility Name

Local Institution

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V4A 2H9

Country

Canada

Facility Name

Local Institution

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

Local Institution

City

Bathurst

State/Province

New Brunswick

ZIP/Postal Code

E2A 4X7

Country

Canada

Facility Name

Local Institution

City

St. John'S

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 3R5

Country

Canada

Facility Name

Local Institution

City

Thornhill

State/Province

Ontario

ZIP/Postal Code

L4J 8L7

Country

Canada

Facility Name

Local Institution

City

Mirabel

State/Province

Quebec

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

Local Institution

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 7H9

Country

Canada

Facility Name

Local Institution

City

Quebec

ZIP/Postal Code

G1N 4V3

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial