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

Primary Purpose

Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-820132
BMS-820132
BMS-820132
BMS-820132
BMS-820132
BMS-820132
BMS-820132
BMS-820132
BMS-820132
Placebo
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Profil Institute For Clinical Research, Inc. (Picr)
  • Clinical Pharmacology Of Miami Inc.
  • Elite Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

BMS-820132 (0.3 mg) or Placebo

BMS-820132 (1.0 mg) or Placebo

BMS-820132 (3 mg) or Placebo

BMS-820132 (10 mg) or Placebo

BMS-820132 (30 mg) or Placebo

BMS-820132 (75 mg) or Placebo

BMS-820132 (150 mg) or Placebo

BMS-820132 (300 mg) or Placebo

BMS-820132 (TBD) or Placebo

Arm Description

Outcomes

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

Secondary Outcome Measures

Exposure to the investigational drug and its metabolites
Pharmacodynamic activity of the investigational drug on biomarkers
Excretion of the investigational drug and metabolites from the body

Full Information

First Posted
April 13, 2010
Last Updated
March 8, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01105429
Brief Title
Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-820132 (0.3 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (1.0 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (3 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (10 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (30 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (75 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (150 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (300 mg) or Placebo
Arm Type
Active Comparator
Arm Title
BMS-820132 (TBD) or Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral, 0.3 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral, 1.0 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral, 3 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral, 10 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral, 30 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral , 75 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral, 150 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Oral Solution, Oral, 300 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-820132
Intervention Description
Capsule, Oral, (TBD), once daily, 2 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Solution, Oral, 0mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, Oral, (TBD), once daily, 2 days
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Exposure to the investigational drug and its metabolites
Time Frame
Within 2 days after study drug administration
Title
Pharmacodynamic activity of the investigational drug on biomarkers
Time Frame
Within 2 days after study drug administration
Title
Excretion of the investigational drug and metabolites from the body
Time Frame
Within 2 days after study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institute For Clinical Research, Inc. (Picr)
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Clinical Pharmacology Of Miami Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Elite Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States

12. IPD Sharing Statement

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

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