A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)

A Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Four-Period Crossover Study to Assess the Effects of Concomitant Administration of MK0431 and Metformin Alone and in Combination on Post-Meal Incretin Hormone Concentrations in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00975052

Enrollment

Registered

2009-09-11

Start date

2006-01-31

Completion date

2006-03-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.

Interventions

DRUGsitagliptin phosphate

100 mg sitagliptin daily for two days in one out of four treatment periods

DRUGComparator: metformin

500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.

DRUGComparator: sitagliptin and metformin

100 mg sitagliptin once daily and 500 mg metformin twice daily on Day 1 and 100 mg sitagliptin once daily and 1000 mg metformin once daily on Day 2 in one of four treatment periods.

DRUGComparator: placebo

Placebo only on Days 1 and 2 in one of four treatment periods.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject is in good health * Subject has been a nonsmoker for at least 6 months * Subject is willing to avoid strenuous activity from the screening visit until the end of the study * Subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration

Exclusion criteria

* Any history of stroke or neurological disorder * Subject has a history of cardiovascular, blood, endocrine or liver diseases * Subject has a history of cancer

Design outcomes

Primary

Measure	Time frame
Weighted average active GLP-1 (glucagonlike peptide-1) concentrations	4 hours after the postdose meal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026