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

Phase 2

Completed

• Conditions: Diabetes Type 2
• Interventions: Drug: BMS-770767; Drug: Placebo; Drug: Metformin

• Registration Number: NCT01046422
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Study Start: 2010-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2012-03-24
• 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: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-770767 ± metformin (Treatment A)	BMS-770767	-
BMS-770767 ± metformin (Treatment A)	Metformin	-
BMS-770767 ± metformin (Treatment B)	BMS-770767	-
BMS-770767 ± metformin (Treatment B)	Metformin	-
BMS-770767 ± metformin (Treatment C)	BMS-770767	-
BMS-770767 ± metformin (Treatment C)	Metformin	-
BMS-770767 ± metformin (Treatment D)	BMS-770767	-
Placebo ± metformin (Treatment E)	Placebo	-
BMS-770767 ± metformin (Treatment D)	Metformin	-
Placebo ± metformin (Treatment E)	Metformin	-

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose Improvement	Within seven days following dosing

Secondary Outcome Measures

Name	Time	Method
Mean daily glucose (3-day 7 pt-fingerstick)	Within 28 days following dosing
Four (4)-hour post-prandial glucose AUC	Within 28 days following dosing
HbA1C	Within 28 days following dosing
Lipid profiles	Within 28 days following dosing

Trial Locations

Locations (3)

Marina Raikhel, Md; 🇺🇸 Lomita, California, United States

Nevada Alliance Against Diabetes; 🇺🇸 Las Vegas, Nevada, United States

Local Institution; 🇰🇷 Suwon, Korea, Republic of