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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01105429
First received: April 13, 2010
Last updated: March 8, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
 Drug: BMS-820132
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Exposure to the investigational drug and its metabolites [ Time Frame: Within 2 days after study drug administration ] [ Designated as safety issue: No ]
  • Pharmacodynamic activity of the investigational drug on biomarkers [ Time Frame: Within 2 days after study drug administration ] [ Designated as safety issue: No ]
  • Excretion of the investigational drug and metabolites from the body [ Time Frame: Within 2 days after study drug administration ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BMS-820132 (0.3 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral, 0.3 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (1.0 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral, 1.0 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (3 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral, 3 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (10 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral, 10 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (30 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral, 30 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (75 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral , 75 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (150 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral, 150 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (300 mg) or Placebo Drug: BMS-820132
Oral Solution, Oral, 300 mg, once daily, 1 day
Drug: Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
Active Comparator: BMS-820132 (TBD) or Placebo Drug: BMS-820132
Capsule, Oral, (TBD), once daily, 2 days
Drug: Placebo
Capsule, Oral, (TBD), once daily, 2 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105429

Locations
United States, California
Profil Institute For Clinical Research, Inc. (Picr)
Chula Vista, California, United States, 91911
United States, Florida
Clinical Pharmacology Of Miami Inc.
Miami, Florida, United States, 33014
Elite Research Institute
Miami, Florida, United States, 33169
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01105429     History of Changes
Other Study ID Numbers: MB122-002
Study First Received: April 13, 2010
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013