NCT00929201

Brief Summary

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 1, 2010

Completed
Last Updated

August 13, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

June 25, 2009

Results QC Date

January 5, 2010

Last Update Submit

July 22, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin

    Serum samples were used to determine the AUC from time 0 to infinity for metformin.

    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose

Secondary Outcomes (1)

  • Peak Plasma Concentration (Cmax) of Metformin

    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose

Study Arms (2)

Sita + Met then Sita/Met FDC

ACTIVE COMPARATOR

Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.

Drug: Sitagliptin phosphate/metformin hydrochloride FDCDrug: Sitagliptin phosphateDrug: Metformin hydrochloride

Sita/Met FDC then Sita + Met

ACTIVE COMPARATOR

Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.

Drug: Sitagliptin phosphate/metformin hydrochloride FDCDrug: Sitagliptin phosphateDrug: Metformin hydrochloride

Interventions

Sitagliptin phosphate/metformin hydrochloride FDCDRUG

Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.

Sita + Met then Sita/Met FDCSita/Met FDC then Sita + Met
Sitagliptin phosphateDRUG

Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Sita + Met then Sita/Met FDCSita/Met FDC then Sita + Met
Metformin hydrochlorideDRUG

Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Sita + Met then Sita/Met FDCSita/Met FDC then Sita + Met

Eligibility Criteria

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

You may qualify if:

  • is in good health
  • is a nonsmoker
  • is willing to follow all study guidelines

You may not qualify if:

  • has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
  • is a nursing mother
  • is unwilling to consume the required high-fat breakfast

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

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

June 25, 2009

First Posted

June 26, 2009

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

August 13, 2015

Results First Posted

February 1, 2010

Record last verified: 2015-07