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

NCT01105429 | Completed Phase 1

• 1 other identifier: MB122-002
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

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

  Within 5 days of study drug administration

Secondary Outcomes (3)

• Exposure to the investigational drug and its metabolites

  Within 2 days after study drug administration

• Pharmacodynamic activity of the investigational drug on biomarkers

  Within 2 days after study drug administration

• Excretion of the investigational drug and metabolites from the body

  Within 2 days after study drug administration

Study Arms (9)

BMS-820132 (0.3 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (1.0 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (3 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (10 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (30 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (75 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (150 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (300 mg) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

BMS-820132 (TBD) or Placebo

ACTIVE COMPARATOR

Drug: BMS-820132; Drug: Placebo

Interventions

BMS-820132 DRUG

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

BMS-820132 (0.3 mg) or Placebo

Placebo DRUG

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

BMS-820132 (0.3 mg) or Placebo; BMS-820132 (1.0 mg) or Placebo; BMS-820132 (10 mg) or Placebo; BMS-820132 (150 mg) or Placebo; BMS-820132 (3 mg) or Placebo; BMS-820132 (30 mg) or Placebo; BMS-820132 (300 mg) or Placebo; BMS-820132 (75 mg) or Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Profil Institute For Clinical Research, Inc. (Picr)

Chula Vista, California, 91911, United States

Location

Clinical Pharmacology Of Miami Inc.

Miami, Florida, 33014, United States

Location

Elite Research Institute

Miami, Florida, 33169, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 16, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 9, 2011

Record last verified: 2010-11

Locations

US (3)