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NCT Number: NCT01105429

Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes

BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institute For Clinical Research, Inc. (Picr), Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile)
  • Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months
  • Body Mass Index (BMI) of 18 to 40 kg/m2
  • Fasting glucose in the range of 100-250 mg/dL
  • Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5%

Exclusion criteria

  • Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression
  • Past history of diabetic ketoacidosis and/or C-peptide < 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery that could impact upon the absorption of study drug
  • Smoking more than 10 cigarettes per day
  • Recent drug or alcohol abuse
  • Women who are pregnant or breastfeeding
  • Positive urine screen for drugs of abuse
  • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody

Treatment and study plan

BMS-820132

Drug

Oral Solution, Oral, 0.3 mg, once daily, 1 day

Placebo

Drug

Oral Solution, Oral, 0mg, once daily, 1 day

Primary outcomes

  1. Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

    Time frame: Within 5 days of study drug administration

Secondary outcomes

  1. Exposure to the investigational drug and its metabolites

    Time frame: Within 2 days after study drug administration

  2. Pharmacodynamic activity of the investigational drug on biomarkers

    Time frame: Within 2 days after study drug administration

  3. Excretion of the investigational drug and metabolites from the body

    Time frame: Within 2 days after study drug administration

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes on Background Therapy of Metformin

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2010
Registry last updated
Mar 9, 2011

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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