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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: BMS-512148; Drug: Placebo	Phase 2

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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
2. 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
3. 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)
4. 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
5. 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.
6. To assess the effects of BMS-512148 on the PK of metformin in diabetic subjects. [ Time Frame: 14 days ]
   Exposure to metformin
7. To identify potential biomarkers in both urine and blood [ Time Frame: 14 days ]
   Serum and urine for metabonomic assessment

Eligibility Criteria

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

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Study Director:	Bristol Myers Squibb	Bristol-Myers Squibb

More Information

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Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 

MB102-003 _CSR_synopsis 

Publications of Results:

Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7. Erratum in: Clin Pharmacol Ther. 2009 May;85(5):558.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00162305 History of Changes
Other Study ID Numbers:	MB102-003
First Posted:	September 13, 2005
Last Update Posted:	October 27, 2016
Last Verified:	October 2016

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases