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 SensitivityIncremental 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
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