NCT00562250

Brief Summary

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

November 21, 2007

Last Update Submit

October 14, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together

    plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose

Secondary Outcomes (2)

  • Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride

    for 72 hours after each administered dose

  • Recorded adverse events

    for 72 hours after each administered dose

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Dapagliflozin

Arm 2

ACTIVE COMPARATOR
Drug: Glimepiride

Arm 3

ACTIVE COMPARATOR
Drug: Dapagliflozin + Glimepiride

Interventions

DapagliflozinDRUG

Tablets, Oral, 20 mg, once daily, single dose

Arm 1
GlimepirideDRUG

Tablets, Oral, 4 mg, once daily, single dose

Arm 2
Dapagliflozin + GlimepirideDRUG

Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

Arm 3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects with BMI of 18-32 kg/m2

You may not qualify if:

  • Abnormal physical or lab findings
  • Allergies to any sulfonylurea or related compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Vicente López, Buenos Aires, 1602, Argentina

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozinglimepiride

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 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 22, 2007

Study Start

May 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

AR(1)