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Completed

NCT Number: NCT01046422

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

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

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Caboolture, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-770767

Drug

Capsule, Oral, 15mg, Active, Daily, 28 days

Placebo

Drug

Capsule, Oral, 0mg, Daily, 28 days

metformin

Drug

Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days

Primary outcomes

  1. Fasting Plasma Glucose Improvement

    Time frame: Within seven days following dosing

Secondary outcomes

  1. Mean daily glucose (3-day 7 pt-fingerstick)

    Time frame: Within 28 days following dosing

  2. Four (4)-hour post-prandial glucose AUC

    Time frame: Within 28 days following dosing

  3. HbA1C

    Time frame: Within 28 days following dosing

  4. Lipid profiles

    Time frame: Within 28 days following dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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