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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01290575
First received: February 2, 2011
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Placebo
Drug: BMS-820132
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments. [ Time Frame: Throughout the study drug administration period (14 days) ] [ Designated as safety issue: Yes ]
  • Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments. [ Time Frame: within 7 days after the final dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of BMS-820132 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-820132 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Trough observed plasma concentration (Cmin) of BMS-820132 [ Time Frame: Day 1 through Day 14 (selected days) ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Accumulation index (AI) of BMS-820132 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Half life (T-Half) of BMS-820132 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis [ Time Frame: Day -1, Day 1, Day 7 and Day 14 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 BMS-820132 or placebo Drug: Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
Drug: BMS-820132
Capsule, Oral, 15mg, twice daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 2 BMS-820132 or placebo Drug: Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
Drug: BMS-820132
Capsule, Oral, 60mg, twice daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 3 BMS-820132 or placebo Drug: Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
Drug: BMS-820132
Capsule, oral, 150mg, twice daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 4 BMS-820132 or placebo Drug: Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
Drug: BMS-820132
Capsule, Oral, 300mg, twice daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 5 BMS-820132 or placebo Drug: Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
Drug: BMS-820132
Capsule, Oral, 450mg, twice daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 6 BMS-820132 or placebo Drug: Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
Drug: BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 7 BMS-820132 or placebo Drug: Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
Drug: BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 8 BMS-820132 or placebo Drug: Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
Drug: BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
Other Name: BMS-820132
Active Comparator: Arm 9 BMS-820132 or placebo Drug: Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
Drug: BMS-820132
Capsule, Oral, 5 mg, twice daily, 14 day

Detailed Description:

Study Classification: Safety, Pharmacokinetics/dynamics

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290575

Locations
United States, Arizona
Dedicated Phase I, Inc.
Phoenix, Arizona, United States, 85013
United States, Arkansas
Osborne Research Center
Little Rock, Arkansas, United States, 72201
United States, Florida
Mra Clinical Research
Miami, Florida, United States, 33143
Clinical Pharmacology Of Miami Inc.
Miami, Florida, United States, 33014
United States, Texas
Cetero Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01290575     History of Changes
Other Study ID Numbers: MB122-004
Study First Received: February 2, 2011
Last Updated: March 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014