NCT01002807

Brief Summary

To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1

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

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

October 26, 2009

Last Update Submit

October 14, 2016

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

  • Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone

    48 hours post-dose

Secondary Outcomes (1)

  • Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments)

    15 timepoints in 48 hours time interval

Study Arms (3)

FDC of dapagliflozin/metformin XR

OTHER
Drug: DapagliflozinDrug: Metformin XR

FDC of dapagliflozin/reduced mass metformin XR

OTHER
Drug: DapagliflozinDrug: Metformin XR

dapagliflozin and Glucophage® XR

OTHER
Drug: DapagliflozinDrug: Glucophage

Interventions

DapagliflozinDRUG

Tablets, Oral, 10 mg, Single Dose

FDC of dapagliflozin/metformin XRFDC of dapagliflozin/reduced mass metformin XRdapagliflozin and Glucophage® XR
Metformin XRDRUG

Tablets, Oral, 1000 mg, Single Dose

FDC of dapagliflozin/metformin XRFDC of dapagliflozin/reduced mass metformin XR
GlucophageDRUG

Tablets, Oral, 1000 mg, Single Dose

Also known as: Glucophage™
dapagliflozin and Glucophage® XR

Eligibility Criteria

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

You may qualify if:

  • Men and women ages 18 to 45 inclusive
  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2

You may not qualify if:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months) gastrointestinal disease
  • Any major surgery within 4 weeks of study drug administration
  • Glucosuria at screening
  • Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
  • Presence of edema on physical exam
  • History of diabetes mellitus
  • History of heart failure
  • History of renal insufficiency
  • History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
  • History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
  • Estimated creatinine clearance (ClCR) of \< 80 mL/min using the Cockcroft Gault formula
  • History of allergy or intolerance to metformin or other similar agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ppd Development, Lp

Austin, Texas, 78744, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(1)