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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290575
• Other study ID #: MB122-004
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2011
• Last updated: March 26, 2012
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Study Classification: Safety, Pharmacokinetics/dynamics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
• Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
• BMS-820132
Capsule, Oral, 15mg, twice daily, 14 day
• BMS-820132
Capsule, Oral, 60mg, twice daily, 14 day
• BMS-820132
Capsule, oral, 150mg, twice daily, 14 day
• BMS-820132
Capsule, Oral, 300mg, twice daily, 14 day
• BMS-820132
Capsule, Oral, 450mg, twice daily, 14 day
• BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
• BMS-820132
Capsule, Oral, 5 mg, twice daily, 14 day

Locations

Country	Name	City	State
United States	Osborne Research Center	Little Rock	Arkansas
United States	Clinical Pharmacology Of Miami Inc.	Miami	Florida
United States	Mra Clinical Research	Miami	Florida
United States	Dedicated Phase I, Inc.	Phoenix	Arizona
United States	Cetero Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.		Throughout the study drug administration period (14 days)	Yes
Primary	Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.		within 7 days after the final dose	Yes
Secondary	Maximum observed plasma concentration (Cmax) of BMS-820132		Day 1 and Day 14	No
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-820132		Day 1 and Day 14	No
Secondary	Trough observed plasma concentration (Cmin) of BMS-820132		Day 1 through Day 14 (selected days)	No
Secondary	Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132		Day 1 and Day 14	No
Secondary	Accumulation index (AI) of BMS-820132		Day 14	No
Secondary	Half life (T-Half) of BMS-820132		Day 14	No
Secondary	AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis		Day -1, Day 1, Day 7 and Day 14	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form