A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BMS-512148; Drug: Placebo

• Registration Number: NCT00162305
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BMS-512148	-
2	BMS-512148	-
3	BMS-512148	-
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects	14 days	Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

Secondary Outcome Measures

Name	Time	Method
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	Exposure to BMS-512148 and BMS-511926
To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis	14 days	Fasting and post-prandial serum glucose, serum fructosamine, serum insulin, and serum C-peptide and urinary glucose and urinary calcium
To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine	14 days	calcium, magnesium, sodium, potassium, phosphate, chloride, uric acid, oxalate, citrate, total protein, albumin, osmolality, deoxypyridinoline (D-pyr) cross-links, C-telopetide (CTX), N-acetyl-β- D-glucoasaminidase (NAG), and β2-microglubulin (β2-MG)
To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on the following safety markers in serum	14 days	Serum osteocalcin, parathyroid hormone (PTH), 25-Vitamin D, and 1,25-Vitamin D
To assess the effect of BMS-512148 administered alone or concomitantly with metformin on the percent inhibition of renal glucose reabsorption	14 days	Percent inhibition of renal glucose resorption over each 0-4 h, 4-8 h, and 8-12 h post-dose interval calculated from the amount of renally filtered glucose and the amount of glucose excreted in the urine for each collection interval.
To assess the effects of BMS-512148 on the PK of metformin in diabetic subjects.	14 days	Exposure to metformin
To identify potential biomarkers in both urine and blood	14 days	Serum and urine for metabonomic assessment

Trial Locations

Locations (1)

Local Institution; 🇺🇸 San Antonio, Texas, United States