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A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: sitagliptin phosphate (Drug); metformin hydrochloride (Drug); Comparator: placebo sitagliptin (Drug); Comparator: placebo metformin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.

Clinical Details

Official title: A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations

Secondary outcome:

β-cell Sensitivity

Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Female subjects must have a negative pregnancy test

- Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA

agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study

- Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months

Exclusion Criteria:

- Subject has a history of stroke, seizures, or major neurological disorders

- Female subject is breastfeeding

- Subject cannot refrain from use of any prescription or non-prescription drugs

beginning 2 weeks prior to first dose of study drug

- Subject consumes more than 3 alcoholic beverages per day

- Subject consumes more than 6 caffeinated beverages per day

- Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks

of screening

- Subject has a history of cancer, except certain skin or cervical cancer or other

cancers treated more than 10 years prior to screening

- Subject has a history of multiple and/or severe allergies or intolerance to drugs or

food

Locations and Contacts

Additional Information

Starting date: December 2008
Last updated: August 3, 2015

Page last updated: August 23, 2015

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