A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects

AstraZeneca1 site in 1 country47 target enrollmentApril 2005

ConditionsDiabetes Mellitus, Type 2

InterventionsPlacebo BMS-512148

DrugsBMS-512148 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Enrollment: 47
Locations: 1
Primary Endpoint: To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical research study is to assess the safety of, exposure to, and biological effects of BMS-512148 in stable Type 2 diabetic subjects

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

August 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive).
•Fasting glucose (FG) \< - 240 mg/dL, while on metformin or antidiabetic diet alone.
•HbA1c (Hemoglobin A1c) in the range of 6.0-10.0%

Exclusion Criteria

•Women of childbearing potential

Arms & Interventions

4

Intervention: Placebo

1

Intervention: BMS-512148

2

Intervention: BMS-512148

3

Intervention: BMS-512148

Outcomes

Primary Outcomes

To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects

Time Frame: 14 days

Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

Secondary Outcomes

To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin(14 days)
To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis(14 days)
To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine(14 days)
To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on the following safety markers in serum(14 days)
To assess the effect of BMS-512148 administered alone or concomitantly with metformin on the percent inhibition of renal glucose reabsorption(14 days)
To assess the effects of BMS-512148 on the PK of metformin in diabetic subjects.(14 days)
To identify potential biomarkers in both urine and blood(14 days)