A Study of the Effects of Co-Administration of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00830076

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: sitagliptin phosphate Drug: Comparator: metformin Drug: Comparator: placebo	Phase I

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations

Further study details as provided by Merck:

Primary Outcome Measures:

Post-prandial glucagon-like peptide-1 (GLP-1) concentrations [ Time Frame: 6 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-prandial C-peptide and insulin concentrations [ Time Frame: 6 hours postdose ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Sitagliptin	Drug: sitagliptin phosphate 100 mg sitagliptin on Day 1 and 100 mg sitagliptin on Day 2. There will be a 7-day washout between treatment periods.
B: Experimental Metformin	Drug: Comparator: metformin Two 500 mg doses of metformin on Day 1 and one 1000 mg dose metformin on Day 2. There will be a 7-day washout between treatment periods.
C: Experimental Sitagliptin + metformin	Drug: sitagliptin phosphate 100 mg sitagliptin on Day 1 and 100 mg sitagliptin on Day 2. There will be a 7-day washout between treatment periods. Drug: Comparator: metformin Two 500 mg doses of metformin on Day 1 and one 1000 mg dose metformin on Day 2. There will be a 7-day washout between treatment periods.
D: Placebo Comparator Placebo	Drug: Comparator: placebo placebo to sitagliptin and metformin for 2 days. There will be a 7-day washout between treatment periods.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830076

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information	Recruiting
Chula Vista, California, United States, 91911
United States, Florida
Call for Information	Recruiting
Miramar, Florida, United States, 33025

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_521, MK0431-110
Study First Received:	January 26, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00830076 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus
Endocrine System Diseases
Hormones
Protease Inhibitors
Sitagliptin

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Incretins
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009