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

Tracking Information

First Received Date ^ICMJE

October 29, 2004

Last Updated Date

September 8, 2008

Start Date ^ICMJE

December 2004

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of sitagliptin after 12 weeks of treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00095056 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability of sitagliptin over 54 weeks

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

Brief Summary

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Diabetes Mellitus, Type 2
Chronic Renal Insufficiency

Intervention ^ICMJE

Drug: sitagliptin phosphate
Drug: Comparator: glipizide

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00095056

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2004_054

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP