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

February 2, 2011
March 26, 2012
February 2011
November 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01290575 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 1 ] [ Designated as safety issue: No ]
  • Pharmacodynamic activity of the investigational drug on biomarkers. [ Time Frame: Days -1 ] [ Designated as safety issue: No ]
  • Excretion of the investigational drug and metabolites from the body. [ Time Frame: Days 1 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 2 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 4 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 6 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 8 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 10 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 12 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 14 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 15 ] [ Designated as safety issue: No ]
  • Exposure to the investigational drug and its metabolites. [ Time Frame: Days 16 ] [ Designated as safety issue: No ]
  • Pharmacodynamic activity of the investigational drug on biomarkers. [ Time Frame: Days 1 ] [ Designated as safety issue: No ]
  • Pharmacodynamic activity of the investigational drug on biomarkers. [ Time Frame: Days 2 ] [ Designated as safety issue: No ]
  • Pharmacodynamic activity of the investigational drug on biomarkers. [ Time Frame: Days 14 ] [ Designated as safety issue: No ]
  • Pharmacodynamic activity of the investigational drug on biomarkers. [ Time Frame: Days 7 ] [ Designated as safety issue: No ]
  • Pharmacodynamic activity of the investigational drug on biomarkers. [ Time Frame: Days 15 ] [ Designated as safety issue: No ]
  • Excretion of the investigational drug and metabolites from the body. [ Time Frame: Days 2 ] [ Designated as safety issue: No ]
  • Excretion of the investigational drug and metabolites from the body. [ Time Frame: Days 14 ] [ Designated as safety issue: No ]
  • Excretion of the investigational drug and metabolites from the body. [ Time Frame: Days 15 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Study Classification: Safety, Pharmacokinetics/dynamics

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Placebo
    capsule, Oral, 0.0mg, twice daily, 14 day
  • Drug: Placebo
    Capsule, Oral, 0.0mg, once daily, 14 day
  • Drug: BMS-820132
    Capsule, Oral, 15mg, twice daily, 14 day
    Other Name: BMS-820132
  • Drug: BMS-820132
    Capsule, Oral, 60mg, twice daily, 14 day
    Other Name: BMS-820132
  • Drug: BMS-820132
    Capsule, oral, 150mg, twice daily, 14 day
    Other Name: BMS-820132
  • Drug: BMS-820132
    Capsule, Oral, 300mg, twice daily, 14 day
    Other Name: BMS-820132
  • Drug: BMS-820132
    Capsule, Oral, 450mg, twice daily, 14 day
    Other Name: BMS-820132
  • Drug: BMS-820132
    Capsule, Oral, To be determined (TBD), once daily, 14 day
    Other Name: BMS-820132
  • Drug: BMS-820132
    Capsule, Oral, 5 mg, twice daily, 14 day
  • Active Comparator: Arm 1 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 2 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 3 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 4 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 5 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 6 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 7 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 8 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
  • Active Comparator: Arm 9 BMS-820132 or placebo
    Interventions:
    • Drug: Placebo
    • Drug: BMS-820132
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01290575
MB122-004
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP