Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

July 27, 2007

Last Updated Date

November 18, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1c level from baseline to 54 weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

HbA1c level from baseline to 54 weeks (based on measurements at clinic visits every 6 weeks) [ Time Frame: 54 weeks ]

Change History

Complete list of historical versions of study NCT00509236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effect of sitagliptin compared with glipizide on hypoglycemic events, HbA1c, FPG [ Time Frame: At the end of 54 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

A review of clinical adverse experiences, laboratory values, weight, vital signs and ECG data [ Time Frame: At the end of 54 weeks ]

Descriptive Information

Brief Title ^ICMJE

Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease

Official Title ^ICMJE

A Multicenter, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control

Brief Summary

The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in patients withT2DM and end-stage renal disease on dialysis

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 2 Diabetes Mellitus Renal Disease, End-Stage
Renal Disease, End-Stage

Intervention ^ICMJE

Drug: sitagliptin phosphate
Drug: Comparator: Comparator: glipizide

Study Arms / Comparison Groups

Experimental: Drug

Publications *

* 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

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient has type 2 diabetes mellitus
Patient is on dialysis

Exclusion Criteria:

Patient has type 1 diabetes mellitus or a history of ketoacidosis. Patient is on a new weight loss program
Patient has active liver disease.
Patient has been on dialysis for less than 6 months

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

United States, Germany, Hong Kong, Israel, Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00509236

Responsible Party

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

Study ID Numbers ^ICMJE

2007_550

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

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