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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105429
• Other study ID #: MB122-002
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2010
• Last updated: March 8, 2011
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

Drug:
• BMS-820132
Oral Solution, Oral, 0.3 mg, once daily, 1 day
• BMS-820132
Oral Solution, Oral, 1.0 mg, once daily, 1 day
• BMS-820132
Oral Solution, Oral, 3 mg, once daily, 1 day
• BMS-820132
Oral Solution, Oral, 10 mg, once daily, 1 day
• BMS-820132
Oral Solution, Oral, 30 mg, once daily, 1 day
• BMS-820132
Oral Solution, Oral , 75 mg, once daily, 1 day
• BMS-820132
Oral Solution, Oral, 150 mg, once daily, 1 day
• BMS-820132
Oral Solution, Oral, 300 mg, once daily, 1 day
• BMS-820132
Capsule, Oral, (TBD), once daily, 2 days
• Placebo
Oral Solution, Oral, 0mg, once daily, 1 day
• Placebo
Capsule, Oral, (TBD), once daily, 2 days

Locations

Country	Name	City	State
United States	Profil Institute For Clinical Research, Inc. (Picr)	Chula Vista	California
United States	Clinical Pharmacology Of Miami Inc.	Miami	Florida
United States	Elite Research Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Exposure to the investigational drug and its metabolites		Within 2 days after study drug administration	No
Secondary	Pharmacodynamic activity of the investigational drug on biomarkers		Within 2 days after study drug administration	No
Secondary	Excretion of the investigational drug and metabolites from the body		Within 2 days after study drug administration	No

External Links

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