NCT00726505

Brief Summary

The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

July 30, 2008

Last Update Submit

October 14, 2016

Conditions

Diabetes, NOS

Outcome Measures

Primary Outcomes (1)

  • The change in urinary glucose excretion dynamics

    after 7 days of treatment

Secondary Outcomes (3)

  • Differences in urinary glucose between healthy and diabetic subjects

    at 7 days

  • Changes in liver glucose production

    at one day

  • Glucose effects on tubular markers

    at one day

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Subjects with T2DM - Dapagliflozin 5 mg

Drug: Dapagliflozin

Group 2

ACTIVE COMPARATOR

Subjects with T2DM - Dapagliflozin 20 mg

Drug: Dapagliflozin

Group 3

ACTIVE COMPARATOR

Healthy Subjects - Dapagliflozin 20 mg

Drug: Dapagliflozin

Interventions

DapagliflozinDRUG

Tablets, Oral, Once Daily, up to 29 days:

Also known as: BMS-512148
Group 1Group 2Group 3

Eligibility Criteria

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

You may qualify if:

  • Male and female subjects
  • Age 18 to 65 years
  • BMI 18 to 35 kg/m2
  • Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
  • No evidence of impaired renal function

You may not qualify if:

  • Unwilling or unable to use an acceptable method of birth control
  • Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
  • Exposure to insulin
  • Evidence of significant kidney disease or any other significant medical or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Texas Health Center At San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose 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 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 1, 2008

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(1)