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

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BMS-512148 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Dapagliflozin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Exposure to metformin
To identify potential biomarkers in both urine and blood [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Serum and urine for metabonomic assessment


Enrollment:	47
Study Start Date:	April 2005
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162305

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

Investigators


Study Director:	Bristol Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

No publications provided


Responsible Party:	Study Director, Bristol Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162305 History of Changes
Other Study ID Numbers:	MB102-003
Study First Received:	September 9, 2005
Last Updated:	June 6, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015