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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Comparator: metformin; Drug: Comparator: sitagliptin and metformin; Drug: Comparator: placebo; Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975052

MK0431-050

2009_661

0431-050

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

A

Active Comparator group

Description:

Sitagliptin alone

Treatment:

Drug: sitagliptin phosphate

B

Active Comparator group

Description:

Metformin alone

Treatment:

Drug: Comparator: metformin

C

Experimental group

Description:

Sitagliptin and metformin concomitantly

Treatment:

Drug: Comparator: sitagliptin and metformin

D

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo