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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

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

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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, Older Adult)
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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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


Locations
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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
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications of Results:

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs