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Completed

NCT Number: NCT00162305

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

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Fort Lauderdale, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-512148

Drug

Capsules, Oral, 100 mg, Once daily, 14 days.

Other names: Dapagliflozin

Placebo

Drug

Capsules, Oral, 0 mg, Once daily, 14 days.

Other names: Dapagliflozin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 13, 2005
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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