Clinical trial NCT01105429: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
timeFrame: Within 5 days of study drug administration
Secondary outcomes:
measure: Exposure to the investigational drug and its metabolites
timeFrame: Within 2 days after study drug administration
measure: Pharmacodynamic activity of the investigational drug on biomarkers
timeFrame: Within 2 days after study drug administration
measure: Excretion of the investigational drug and metabolites from the body
timeFrame: Within 2 days after study drug administration
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute For Clinical Research, Inc. (Picr)
state: California
city: Miami
country: United States
facility: Clinical Pharmacology Of Miami Inc.
state: Florida
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: