Clinical trial NCT01046422: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Type 2
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Fasting Plasma Glucose Improvement
timeFrame: Within seven days following dosing
Secondary outcomes:
measure: Mean daily glucose (3-day 7 pt-fingerstick)
timeFrame: Within 28 days following dosing
measure: Four (4)-hour post-prandial glucose AUC
timeFrame: Within 28 days following dosing
measure: HbA1C
timeFrame: Within 28 days following dosing
measure: Lipid profiles
timeFrame: Within 28 days following dosing
Other outcomes:
Locations:
city: Lomita
country: United States
facility: Marina Raikhel, Md
state: California
city: Las Vegas
country: United States
facility: Nevada Alliance Against Diabetes
state: Nevada
city: Caboolture
country: Australia
facility: Local Institution
state: Queensland
city: Meadowbrook
country: Australia
facility: Local Institution
state: Queensland
city: Daw Park
country: Australia
facility: Local Institution
state: South Australia
city: Geelong
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Mount Pearl
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Charlottetown
country: Canada
facility: Local Institution
state: Prince Edward Island
city: Drummondville
country: Canada
facility: Local Institution
state: Quebec
city: Lachine
country: Canada
facility: Local Institution
state: Quebec
city: Laval
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: