Back to resultsSafety Study of BMS-770767 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes Type 2
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-770767
BMS-770767
BMS-770767
BMS-770767
Placebo
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Type 2
Eligibility Criteria
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
Sites / Locations
- Marina Raikhel, Md
- Nevada Alliance Against Diabetes
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BMS-770767 ± metformin (Treatment A)
BMS-770767 ± metformin (Treatment B)
BMS-770767 ± metformin (Treatment C)
BMS-770767 ± metformin (Treatment D)
Placebo ± metformin (Treatment E)
Arm Description
Outcomes
Primary Outcome Measures
Fasting Plasma Glucose Improvement
Secondary Outcome Measures
Mean daily glucose (3-day 7 pt-fingerstick)
Four (4)-hour post-prandial glucose AUC
HbA1C
Lipid profiles
Full Information
NCT ID
NCT01046422
First Posted
January 11, 2010
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01046422
Brief Title
Safety Study of BMS-770767 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-770767 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
May 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
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-770767 ± metformin (Treatment A)
Arm Type
Experimental
Arm Title
BMS-770767 ± metformin (Treatment B)
Arm Type
Experimental
Arm Title
BMS-770767 ± metformin (Treatment C)
Arm Type
Experimental
Arm Title
BMS-770767 ± metformin (Treatment D)
Arm Type
Experimental
Arm Title
Placebo ± metformin (Treatment E)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Capsule, Oral, 15mg, Active, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Capsule, Oral, 50mg, Active, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Capsule, Oral, 150mg, Active, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Capsule, Oral, 50mg BID, Active, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, Oral, 0mg, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Primary Outcome Measure Information:
Title
Fasting Plasma Glucose Improvement
Time Frame
Within seven days following dosing
Secondary Outcome Measure Information:
Title
Mean daily glucose (3-day 7 pt-fingerstick)
Time Frame
Within 28 days following dosing
Title
Four (4)-hour post-prandial glucose AUC
Time Frame
Within 28 days following dosing
Title
HbA1C
Time Frame
Within 28 days following dosing
Title
Lipid profiles
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
No
Eligibility Criteria
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
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
Marina Raikhel, Md
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Nevada Alliance Against Diabetes
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Local Institution
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
Local Institution
City
Meadowbrook
State/Province
Queensland
ZIP/Postal Code
4131
Country
Australia
Facility Name
Local Institution
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Local Institution
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3P 1R9
Country
Canada
Facility Name
Local Institution
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Local Institution
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Local Institution
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 5Y9
Country
Canada
Facility Name
Local Institution
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
Local Institution
City
Lachine
State/Province
Quebec
ZIP/Postal Code
H8S 2E4
Country
Canada
Facility Name
Local Institution
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3J 2V5
Country
Canada
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
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