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: metformin Drug: Comparator: placebo	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

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 ]

Enrollment:	16
Study Start Date:	January 2009
Study Completion Date:	June 2009
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: 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: 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

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:	June 12, 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 September 03, 2009