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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00509236

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Renal Disease, End-Stage	Drug: sitagliptin phosphate Drug: Comparator: glipizide Drug: Comparator: Placebo (unspecified)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, 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

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:

HbA1c level from baseline to 54 weeks (based on measurements at clinic visits every 6 weeks) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A review of clinical adverse experiences, laboratory values, weight, vital signs and ECG data [ Time Frame: At the end of 54 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: drug	Drug: sitagliptin phosphate sitagliptin phosphate 25mg tablet, for a 54-wk treatment period. Drug: Comparator: Placebo (unspecified) Glipizide 2.5mg Pbo qd, for a 54-wk treatment period.
2: Active Comparator Arm 2: Active comparator	Drug: Comparator: glipizide glipizide 2.5mg qd, titrating up to 10mg bid, based on glycemic control for a 54-wk treatment period. Drug: Comparator: Placebo (unspecified) sitagliptin 25mg Pbo tablet, for a 54-wk treatment period.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509236

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Arizona
Call for Information	Recruiting
Tempe, Arizona, United States, 85284
United States, California
Call for Information	Recruiting
Whittier, California, United States, 90603
Call for Information	Recruiting
Tarzana, California, United States, 91356
Call for Information	Recruiting
Sacramento, California, United States, 95825
Call for Information	Recruiting
Mission Hills, California, United States, 91345
United States, Connecticut
Call for Information	Recruiting
Middleburg, Connecticut, United States, 06762
United States, Florida
Call for Information	Recruiting
Hudson, Florida, United States, 34667
United States, Georgia
Call for Information	Recruiting
Macon, Georgia, United States, 31217
United States, New Jersey
Call for Information	Recruiting
Paterson, New Jersey, United States, 07503
United States, New York
Call for Information	Recruiting
Yonkers, New York, United States, 10710
Call for Information	Recruiting
Buffalo, New York, United States, 14209
United States, Ohio
Call for Information	Recruiting
Cincinnati, Ohio, United States, 45267-0585
United States, South Carolina
Call for Information	Recruiting
Orangeburg, South Carolina, United States, 29118
Germany
Msd Sharp & Dohme Gmbh	Recruiting
Haar, Germany, 85540
Contact: Thomas Lang 49-89-4561-1536
Hong Kong, Hong Kong Island
Merck Sharp & Dohme (Asia) Ltd.	Recruiting
Causeway Bay, Hong Kong Island, Hong Kong
Contact: Jane Lin 862-1639-15522
Israel
Merck Sharp & Dohme Co. Ltd.	Recruiting
Petah Tikva, Israel, 49192
Contact: Raanan Cohen 972-3-9274005
Russian Federation
Merck Sharp & Dohme IDEA, Inc.	Recruiting
Moscow, Russian Federation, 121059
Contact: Tatiana Serebriakova 7-495-941-8264

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:	2007_550, MK0431-073
Study First Received:	July 27, 2007
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00509236 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Renal Insufficiency
Glipizide
Metabolic Diseases
Kidney Failure, Chronic
Diabetes Mellitus
Endocrine System Diseases
Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents
Urologic Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Kidney Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Glipizide
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diabetes Mellitus
Kidney Failure, Chronic
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
Kidney Failure

ClinicalTrials.gov processed this record on July 02, 2009