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

NCT ID: NCT01105429

Last Updated: 2011-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BMS-820132 (0.3 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

BMS-820132 (1.0 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Oral Solution, Oral, 1.0 mg, once daily, 1 day

Placebo

Intervention Type DRUG

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

BMS-820132 (3 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Oral Solution, Oral, 3 mg, once daily, 1 day

Placebo

Intervention Type DRUG

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

BMS-820132 (10 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Oral Solution, Oral, 10 mg, once daily, 1 day

Placebo

Intervention Type DRUG

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

BMS-820132 (30 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Oral Solution, Oral, 30 mg, once daily, 1 day

Placebo

Intervention Type DRUG

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

BMS-820132 (75 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Oral Solution, Oral , 75 mg, once daily, 1 day

Placebo

Intervention Type DRUG

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

BMS-820132 (150 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Oral Solution, Oral, 150 mg, once daily, 1 day

Placebo

Intervention Type DRUG

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

BMS-820132 (300 mg) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Oral Solution, Oral, 300 mg, once daily, 1 day

Placebo

Intervention Type DRUG

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

BMS-820132 (TBD) or Placebo

Group Type ACTIVE_COMPARATOR

BMS-820132

Intervention Type DRUG

Capsule, Oral, (TBD), once daily, 2 days

Placebo

Intervention Type DRUG

Capsule, Oral, (TBD), once daily, 2 days

Interventions

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BMS-820132

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

Intervention Type DRUG

BMS-820132

Oral Solution, Oral, 1.0 mg, once daily, 1 day

Intervention Type DRUG

BMS-820132

Oral Solution, Oral, 3 mg, once daily, 1 day

Intervention Type DRUG

BMS-820132

Oral Solution, Oral, 10 mg, once daily, 1 day

Intervention Type DRUG

BMS-820132

Oral Solution, Oral, 30 mg, once daily, 1 day

Intervention Type DRUG

BMS-820132

Oral Solution, Oral , 75 mg, once daily, 1 day

Intervention Type DRUG

BMS-820132

Oral Solution, Oral, 150 mg, once daily, 1 day

Intervention Type DRUG

BMS-820132

Oral Solution, Oral, 300 mg, once daily, 1 day

Intervention Type DRUG

BMS-820132

Capsule, Oral, (TBD), once daily, 2 days

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Placebo

Capsule, Oral, (TBD), once daily, 2 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Profil Institute For Clinical Research, Inc. (Picr)

Chula Vista, California, United States

Site Status

Clinical Pharmacology Of Miami Inc.

Miami, Florida, United States

Site Status

Elite Research Institute

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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MB122-002

Identifier Type: -

Identifier Source: org_study_id

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