The Effect of Sitagliptin in T2DM With Inadequate Glycemic Control

This study is currently recruiting participants.

Verified by Merck, August 2009

First Received: January 28, 2009 Last Updated: August 5, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00832624

Purpose

To assess the effect of treatment with MK0431 on HbA1c and the safety and tolerability of MK0431.

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: sitagliptin phosphate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open, Not Controlled Study to Evaluate the Effect of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

HbA1c [ Time Frame: 18 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental sitagliptin	Drug: sitagliptin phosphate Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are 18 years of age with Type 2 Diabetes Mellitus who are either:
1. Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months); Or
2. On A Single Aha

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832624

Locations

Brazil, SP
Merck Sharp & Dohme Farmaceutica Ltda.	Recruiting
Sao Paulo, SP, Brazil, 04717-004
Contact: Jose Octavio P. Costa Filo 55-11-5189-7942

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_526, MK0431-118
Study First Received:	January 28, 2009
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00832624 History of Changes
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Pharmacologic Actions
Protease Inhibitors
Sitagliptin

ClinicalTrials.gov processed this record on August 28, 2009