An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

This study has been completed.

First Received: October 29, 2004 Last Updated: January 21, 2010 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00095056

Purpose

The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Chronic Renal Insufficiency	Drug: sitagliptin phosphate Drug: Comparator: glipizide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:	Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glipizide Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability of sitagliptin after 12 weeks of treatment

Secondary Outcome Measures:

Safety and tolerability of sitagliptin over 54 weeks

Enrollment:	90
Study Start Date:	December 2004
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment - 54 wks

Duration of Treatment - 42 wks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (T2DM) (a specific type of diabetes).
Patient has renal (kidney) insufficiency (inadequate kidney function)

Exclusion Criteria:

Patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate.
Pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095056

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Chan JC, Scott R, Arjona Ferreira JC, Sheng D, Gonzalez E, Davies MJ, Stein PP, Kaufman KD, Amatruda JM, Williams-Herman D. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab. 2008 Jul;10(7):545-55. Epub 2008 Jun 1.

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_054, MK0431-028
Study First Received:	October 29, 2004
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00095056 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Glipizide
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Pharmacologic Actions

Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Urologic Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010