Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE April 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Serum fructosamine at 14 days; 4h OGTT evaluations for serum glucose and insulin at 2 and 13 days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
Official Title  ICMJE A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: BMS-512148
    Capsules, Oral, 100 mg, Once daily, 14 days.
    Other Name: Dapagliflozin
  • Drug: BMS-512148
    Capsules, Oral, 25 mg, Once daily, 14 days.
    Other Name: Dapagliflozin
  • Drug: BMS-512148
    Capsules, Oral, 5 mg, Once daily, 14 days.
    Other Name: Dapagliflozin
  • Drug: Placebo
    Capsules, Oral, 0 mg, Once daily, 14 days.
    Other Name: Dapagliflozin
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: BMS-512148
  • Active Comparator: 2
    Intervention: Drug: BMS-512148
  • Active Comparator: 3
    Intervention: Drug: BMS-512148
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2011)
47
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162305
Other Study ID Numbers  ICMJE MB102-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
PRS Account AstraZeneca
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP