NCT00961480

Brief Summary

A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1 type-2-diabetes

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

October 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1 month

First QC Date

August 18, 2009

Last Update Submit

June 8, 2015

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.

    Up to 72 hours postdose

Secondary Outcomes (1)

  • Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.

    Up to 72 hours postdose

Study Arms (6)

Treatment A

ACTIVE COMPARATOR

50 mg sitagliptin and 500 mg metformin as individual tablets

Drug: sitagliptin phosphate (+) metformin hydrochlorideDrug: Comparator: metformin 500mgDrug: Comparator: sitagliptin

Treatment B

EXPERIMENTAL

sitagliptin/metformin 50 mg/500 mg tablet

Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet

Treatment C

ACTIVE COMPARATOR

50 mg sitagliptin and 1000 mg metformin as individual tablets

Drug: Comparator: sitagliptinDrug: Comparator: metformin 1000 mg

Treatment D

EXPERIMENTAL

sitagliptin/metformin 50 mg/1000 mg tablet

Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Treatment E

ACTIVE COMPARATOR

50 mg sitagliptin and 850 mg metformin as individual tablets

Drug: Comparator: sitagliptinDrug: Comparator: metformin 850 mg

Treatment F

EXPERIMENTAL

sitagliptin/metformin 50 mg/850 mg tablet

Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Interventions

sitagliptin phosphate (+) metformin hydrochlorideDRUG

place holder - do not post

Treatment A
Comparator: metformin 500mgDRUG

A single dose of metformin 500 mg tablet

Also known as: Glucophage
Treatment A
Comparator: sitagliptinDRUG

A single dose of 50 mg sitagliptin tablet

Also known as: Januvia
Treatment ATreatment CTreatment E
Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tabletDRUG

A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

Treatment B
Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tabletDRUG

A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Treatment D
Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tabletDRUG

A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Treatment F
Comparator: metformin 1000 mgDRUG

A single dose of metformin 1000 mg tablet

Also known as: Glucophage
Treatment C
Comparator: metformin 850 mgDRUG

A single dose of metformin 850 mg tablet

Also known as: Glucophage
Treatment E

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
  • Subject is in good health and is a non-smoker

You may not qualify if:

  • Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder
  • Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • Subject is a nursing mother
  • Subject consumes excessive amounts of alcohol or caffeine
  • Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    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

August 18, 2009

First Posted

August 19, 2009

Study Start

October 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

June 9, 2015

Record last verified: 2015-06