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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Diabetes Type 2

Treatments

Drug: Metformin
Drug: BMS-770767
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01046422
MB117-003
2009-014308-79 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

76 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

76 participants in 5 patient groups, including a placebo group

BMS-770767 ± metformin (Treatment A)
Experimental group
Treatment:
Drug: BMS-770767
Drug: BMS-770767
Drug: Metformin
Drug: BMS-770767
Drug: BMS-770767
BMS-770767 ± metformin (Treatment B)
Experimental group
Treatment:
Drug: BMS-770767
Drug: BMS-770767
Drug: Metformin
Drug: BMS-770767
Drug: BMS-770767
BMS-770767 ± metformin (Treatment C)
Experimental group
Treatment:
Drug: BMS-770767
Drug: BMS-770767
Drug: Metformin
Drug: BMS-770767
Drug: BMS-770767
BMS-770767 ± metformin (Treatment D)
Experimental group
Treatment:
Drug: BMS-770767
Drug: BMS-770767
Drug: Metformin
Drug: BMS-770767
Drug: BMS-770767
Placebo ± metformin (Treatment E)
Placebo Comparator group
Treatment:
Drug: Metformin
Drug: Placebo

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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