Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
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.
1 other identifier
interventional
67
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes
Started Feb 2011
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 2, 2011
CompletedFirst Posted
Study publicly available on registry
February 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMarch 27, 2012
March 1, 2012
9 months
February 2, 2011
March 26, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Throughout the study drug administration period (14 days)
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
within 7 days after the final dose
Secondary Outcomes (7)
Maximum observed plasma concentration (Cmax) of BMS-820132
Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-820132
Day 1 and Day 14
Trough observed plasma concentration (Cmin) of BMS-820132
Day 1 through Day 14 (selected days)
Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132
Day 1 and Day 14
Accumulation index (AI) of BMS-820132
Day 14
- +2 more secondary outcomes
Study Arms (9)
Arm 1 BMS-820132 or placebo
ACTIVE COMPARATORArm 2 BMS-820132 or placebo
ACTIVE COMPARATORArm 3 BMS-820132 or placebo
ACTIVE COMPARATORArm 4 BMS-820132 or placebo
ACTIVE COMPARATORArm 5 BMS-820132 or placebo
ACTIVE COMPARATORArm 6 BMS-820132 or placebo
ACTIVE COMPARATORArm 7 BMS-820132 or placebo
ACTIVE COMPARATORArm 8 BMS-820132 or placebo
ACTIVE COMPARATORArm 9 BMS-820132 or placebo
ACTIVE COMPARATORInterventions
capsule, Oral, 0.0mg, twice daily, 14 day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Dedicated Phase I, Inc.
Phoenix, Arizona, 85013, United States
Osborne Research Center
Little Rock, Arkansas, 72201, United States
Clinical Pharmacology Of Miami Inc.
Miami, Florida, 33014, United States
Mra Clinical Research
Miami, Florida, 33143, United States
Cetero Research
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2011
First Posted
February 7, 2011
Study Start
February 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
March 27, 2012
Record last verified: 2012-03