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

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes on Background Therapy of Metformin

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01105429

Enrollment

Registered

2010-04-16

Start date

2010-05-31

Completion date

2010-10-31

Last updated

2011-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

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 single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.

Interventions

DRUGBMS-820132

Oral Solution, Oral, 0.3 mg, once daily, 1 day

DRUGPlacebo

Oral Solution, Oral, 0mg, once daily, 1 day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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 on a stable regimen for at least 2 months * Body Mass Index (BMI) of 18 to 40 kg/m2 * Fasting glucose in the range of 100-250 mg/dL * Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5%

Exclusion criteria

* Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression * Past history of diabetic ketoacidosis and/or C-peptide \< 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia * 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 HIV-1, -2 antibody

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments	Within 5 days of study drug administration

Secondary

Measure	Time frame
Exposure to the investigational drug and its metabolites	Within 2 days after study drug administration
Pharmacodynamic activity of the investigational drug on biomarkers	Within 2 days after study drug administration
Excretion of the investigational drug and metabolites from the body	Within 2 days after study drug administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026