NCT00162305

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

September 9, 2005

Last Update Submit

October 26, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

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

    Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

    14 days

Secondary Outcomes (7)

  • To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin

    14 days

  • To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis

    14 days

  • To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine

    14 days

  • To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on the following safety markers in serum

    14 days

  • To assess the effect of BMS-512148 administered alone or concomitantly with metformin on the percent inhibition of renal glucose reabsorption

    14 days

  • +2 more secondary outcomes

Study Arms (4)

1

ACTIVE COMPARATOR
Drug: BMS-512148

2

ACTIVE COMPARATOR
Drug: BMS-512148

3

ACTIVE COMPARATOR
Drug: BMS-512148

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BMS-512148DRUG

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

Also known as: Dapagliflozin
1
PlaceboDRUG

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

Also known as: Dapagliflozin
4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Women of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Local Institution

Fort Lauderdale, Florida, 33301, United States

Location

Local Institution

Miami, Florida, 33169, United States

Location

Local Institution

Orlando, Florida, 32809, United States

Location

Local Institution

New Orleans, Louisiana, 70119, United States

Location

Local Institution

San Antonio, Texas, 78229-3894, United States

Location

Related Publications (1)

  • 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.

    PMID: 19129749RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bristol Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

April 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(5)