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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: BMS-820132

• Registration Number: NCT01290575
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 BMS-820132 or placebo	Placebo	-
Arm 2 BMS-820132 or placebo	Placebo	-
Arm 2 BMS-820132 or placebo	BMS-820132	-
Arm 3 BMS-820132 or placebo	Placebo	-
Arm 3 BMS-820132 or placebo	BMS-820132	-
Arm 4 BMS-820132 or placebo	Placebo	-
Arm 4 BMS-820132 or placebo	BMS-820132	-
Arm 5 BMS-820132 or placebo	Placebo	-
Arm 5 BMS-820132 or placebo	BMS-820132	-
Arm 6 BMS-820132 or placebo	Placebo	-
Arm 6 BMS-820132 or placebo	BMS-820132	-
Arm 7 BMS-820132 or placebo	Placebo	-
Arm 7 BMS-820132 or placebo	BMS-820132	-
Arm 1 BMS-820132 or placebo	BMS-820132	-
Arm 8 BMS-820132 or placebo	Placebo	-
Arm 8 BMS-820132 or placebo	BMS-820132	-
Arm 9 BMS-820132 or placebo	Placebo	-
Arm 9 BMS-820132 or placebo	BMS-820132	-

Primary Outcome Measures

Name	Time	Method
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.	within 7 days after the final dose

Secondary Outcome Measures

Name	Time	Method
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
AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis	Day -1, Day 1, Day 7 and Day 14
Trough observed plasma concentration (Cmin) of BMS-820132	Day 1 through Day 14 (selected days)
Accumulation index (AI) of BMS-820132	Day 14
Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132	Day 1 and Day 14
Half life (T-Half) of BMS-820132	Day 14

Trial Locations

Locations (5)

Clinical Pharmacology Of Miami Inc.; 🇺🇸 Miami, Florida, United States

Osborne Research Center; 🇺🇸 Little Rock, Arkansas, United States

Mra Clinical Research; 🇺🇸 Miami, Florida, United States

Cetero Research; 🇺🇸 San Antonio, Texas, United States

Dedicated Phase I, Inc.; 🇺🇸 Phoenix, Arizona, United States