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

Diabetes Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046422
• Other study ID #: MB117-003
• Secondary ID: 2009-014308-79
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2010
• Last updated: September 23, 2015
• Start date: May 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaKorea: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• BMS-770767
Capsule, Oral, 15mg, Active, Daily, 28 days
• BMS-770767
Capsule, Oral, 50mg, Active, Daily, 28 days
• BMS-770767
Capsule, Oral, 150mg, Active, Daily, 28 days
• BMS-770767
Capsule, Oral, 50mg BID, Active, Daily, 28 days
• Placebo
Capsule, Oral, 0mg, Daily, 28 days
• Metformin
Tablet, Oral, = 1500mg, Active, Daily, 28 days

Locations

Country	Name	City	State
Australia	Local Institution	Caboolture	Queensland
Australia	Local Institution	Daw Park	South Australia
Australia	Local Institution	Geelong	Victoria
Australia	Local Institution	Meadowbrook	Queensland
Australia	Local Institution	Nedlands	Western Australia
Canada	Local Institution	Brampton	Ontario
Canada	Local Institution	Charlottetown	Prince Edward Island
Canada	Local Institution	Drummondville	Quebec
Canada	Local Institution	Lachine	Quebec
Canada	Local Institution	Laval	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Mount Pearl	Newfoundland and Labrador
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Winnipeg	Manitoba
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Suwon
United States	Nevada Alliance Against Diabetes	Las Vegas	Nevada
United States	Marina Raikhel, Md	Lomita	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose Improvement		Within seven days following dosing	No
Secondary	Mean daily glucose (3-day 7 pt-fingerstick)		Within 28 days following dosing	No
Secondary	Four (4)-hour post-prandial glucose AUC		Within 28 days following dosing	No
Secondary	HbA1C		Within 28 days following dosing	No
Secondary	Lipid profiles		Within 28 days following dosing	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form