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

NCT ID: NCT00975052

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-03-31

Brief Summary

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Sitagliptin alone

Group Type: ACTIVE_COMPARATOR

sitagliptin phosphate

Intervention Type: DRUG

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

B

Metformin alone

Group Type: ACTIVE_COMPARATOR

Comparator: metformin

Intervention Type: DRUG

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

C

Sitagliptin and metformin concomitantly

Group Type: EXPERIMENTAL

Comparator: sitagliptin and metformin

Intervention Type: DRUG

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.

D

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

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

Interventions

sitagliptin phosphate

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

Intervention Type: DRUG

Comparator: metformin

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

Intervention Type: DRUG

Comparator: 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.

Intervention Type: DRUG

Comparator: placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Migoya EM, Bergeron R, Miller JL, Snyder RN, Tanen M, Hilliard D, Weiss B, Larson P, Gutierrez M, Jiang G, Liu F, Pryor KA, Yao J, Zhu L, Holst JJ, Deacon C, Herman G, Thornberry N, Amatruda J, Williams-Herman D, Wagner JA, SinhaRoy R. Dipeptidyl peptidase-4 inhibitors administered in combination with metformin result in an additive increase in the plasma concentration of active GLP-1. Clin Pharmacol Ther. 2010 Dec;88(6):801-8. doi: 10.1038/clpt.2010.184. Epub 2010 Nov 3.

Reference Type: RESULT

PMID: 21048706 (View on PubMed)

Other Identifiers

MK0431-050

Identifier Type: -

Identifier Source: secondary_id

2009_661

Identifier Type: -

Identifier Source: secondary_id

0431-050

Identifier Type: -

Identifier Source: org_study_id