A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
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ClinicalTrials.gov Identifier: NCT00162305 |
Recruitment Status :
Completed
First Posted : September 13, 2005
Last Update Posted : October 27, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: BMS-512148 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | August 2005 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: BMS-512148
Capsules, Oral, 100 mg, Once daily, 14 days.
Other Name: Dapagliflozin |
Active Comparator: 2 |
Drug: BMS-512148
Capsules, Oral, 25 mg, Once daily, 14 days.
Other Name: Dapagliflozin |
Active Comparator: 3 |
Drug: BMS-512148
Capsules, Oral, 5 mg, Once daily, 14 days.
Other Name: Dapagliflozin |
Placebo Comparator: 4 |
Drug: Placebo
Capsules, Oral, 0 mg, Once daily, 14 days.
Other Name: Dapagliflozin |
- 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
- To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 14 days ]Exposure to metformin
- To identify potential biomarkers in both urine and blood [ Time Frame: 14 days ]Serum and urine for metabonomic assessment

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162305
United States, Florida | |
Local Institution | |
Fort Lauderdale, Florida, United States, 33301 | |
Local Institution | |
Miami, Florida, United States, 33169 | |
Local Institution | |
Orlando, Florida, United States, 32809 | |
United States, Louisiana | |
Local Institution | |
New Orleans, Louisiana, United States, 70119 | |
United States, Texas | |
Local Institution | |
San Antonio, Texas, United States, 78229-3894 |
Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Publications of Results:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00162305 |
Other Study ID Numbers: |
MB102-003 |
First Posted: | September 13, 2005 Key Record Dates |
Last Update Posted: | October 27, 2016 |
Last Verified: | October 2016 |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Dapagliflozin Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |