Clinical trial NCT01290575: Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
Official title: Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes Treated With Metformin Monotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.

Detailed description: Study Classification: Safety, Pharmacokinetics/dynamics

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 (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months.
* Body Mass Index (BMI) of 18.5 to 40 kg/m2.
* Fasting glucose in the range of 125-275 mg/dL.
* Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%.
* Fasting C-peptide \> 1 ng/mL.

Exclusion Criteria:

* Clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations, and any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, depression, or hypothyroidism.
* History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness.
* 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 Human Immunodeficiency Virus (HIV)-1, -2 antibody.

Primary outcomes:
measure: Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
timeFrame: Throughout the study drug administration period (14 days)
measure: Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
timeFrame: within 7 days after the final dose
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-820132
timeFrame: Day 1 and Day 14
measure: Time of maximum observed plasma concentration (Tmax) of BMS-820132
timeFrame: Day 1 and Day 14
measure: Trough observed plasma concentration (Cmin) of BMS-820132
timeFrame: Day 1 through Day 14 (selected days)
measure: Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132
timeFrame: Day 1 and Day 14
measure: Accumulation index (AI) of BMS-820132
timeFrame: Day 14
measure: Half life (T-Half) of BMS-820132
timeFrame: Day 14
measure: AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis
timeFrame: Day -1, Day 1, Day 7 and Day 14
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dedicated Phase I, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Osborne Research Center
state: Arkansas
city: Miami
country: United States
facility: Clinical Pharmacology Of Miami Inc.
state: Florida
city: Miami
country: United States
facility: Mra Clinical Research
state: Florida
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: