Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00509262

Purpose

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in patients with moderate and severe renal insufficiency.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency 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 change from baseline to 54 weeks compared to glipizide. [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Lower incidence of hypoglycemic events compared to glipizide [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effects of sitagliptin compared with glipizide on body weight and FPG. [ Time Frame: over 54 weeks ] [ Designated as safety issue: No ]
Change from baseline of sitagliptin on HbA1c [ Time Frame: over 54 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Arm 1: drug + Pbo comparator	Drug: Comparator: sitagliptin phosphate sitagliptin phosphate 25mg tablets for up to a 54-wk treatment period Drug: Comparator: Comparator: Placebo (unspecified) glipizide Pbo scored tablet qd, for up to a 54-wk treatment period. Drug: Comparator: Comparator: Placebo (unspecified) sitagliptin Pbo 25mg tablets, for up to a 54-wk treatment period
2: Placebo Comparator Arm 2: drug + Pbo comparator	Drug: Comparator: sitagliptin phosphate sitagliptin phosphate 25mg tablets for up to a 54-wk treatment period Drug: Comparator: Comparator: Placebo (unspecified) glipizide Pbo scored tablet qd, for up to a 54-wk treatment period. Drug: Comparator: Comparator: Placebo (unspecified) sitagliptin Pbo 25mg tablets, for up to a 54-wk treatment period
3: Active Comparator Arm 3: Active comparator	Drug: Comparator: Comparator: glipizide glipizide 2.5mg scored tablet, titrating up to 10mg bid for up to 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 has moderate or severe renal insufficiency

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 is on dialysis or is likely to need dialysis during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509262

Contacts

Contact: Toll Free Number

1-888-577-8839

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Locations

United States, California
Call for Information	Recruiting
Long Beach, California, United States, 90822
Call for Information	Recruiting
Mission Hills, California, United States, 91345
Call for Information	Recruiting
Reseda, California, United States, 91335
United States, Florida
Call for Information	Recruiting
Hialeah, Florida, United States, 33012
United States, Michigan
Call for Information	Recruiting
Detroit, Michigan, United States, 48201-0000
United States, Nevada
Call for Information	Recruiting
Las Vegas, Nevada, United States, 89101
United States, North Carolina
Call for Information	Recruiting
Raleigh, North Carolina, United States, 27609
United States, Texas
Call for Information	Recruiting
Dallas, Texas, United States, 75246
Call for Information	Recruiting
San Antonio, Texas, United States, 78229
Call for Information	Recruiting
San Antonio, Texas, United States, 78224
United States, Virginia
Call for Information	Recruiting
Salem, Virginia, United States, 24153
Chile
Merck Sharp & Dohme (I.A.) Corp.	Recruiting
Santiago, Chile, 6761641
Contact: Jorge Vinces 51-1-411-5933
Colombia, Cundinamarca
Frosst Laboratories Inc.	Recruiting
Bogota, Cundinamarca, Colombia
Contact: Felipe Arbelaez 57-1-592-4400
Costa Rica
Merck Sharp & Dohme (I.A.) Corp.	Recruiting
San Jose, Costa Rica
Contact: Patricia Salazar 506-2210-0116
France
Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
Paris Cedex 8, France, 75114
Contact: Jean-Marie Goehrs 33-1-4754-89-90
Germany
Msd Sharp & Dohme Gmbh	Recruiting
Haar, Germany, 85540
Contact: Thomas Lang 49-89-4561-1536
Guatemala
MSD Guatemala	Recruiting
Guatemala, Guatemala, 1010
Contact: Patricia Salazar 506-2210-0116
Hong Kong, Hong Kong Island
Merck Sharp & Dohme (Asia) Ltd.	Recruiting
Causeway Bay, Hong Kong Island, Hong Kong
Contact: Jane Lin 862-1639-15522
India
MSD Pharmaceuticals Private Ltd.	Recruiting
New Delhi, India, 110011
Contact: Swashraya Shah 91-124-464-7338
Israel
Merck Sharp & Dohme Co. Ltd.	Recruiting
Petah Tikva, Israel, 49192
Contact: Raanan Cohen 972-3-9274005
Lebanon
Merck Sharpe & Dohme Idea Inc.	Recruiting
Lebanon Site Information, Lebanon
Contact: Amal Chalfoun 961-4-542590
Lithuania, Lietuva
UAB Merck Sharp & Dohme	Recruiting
Vilnius, Lietuva, Lithuania
Contact: Andrius Bacevicius 3705 2 780 243
Malaysia
Merck Sharp & Dohme (I.A.) Corp	Recruiting
Selangor, Malaysia, 46300
Contact: Nazrin Azli 603-77181748
Mexico, D.F.
Merck Sharp & Dohme De Mexico, S.A. De C.V.	Recruiting
Mexico, D.F., Mexico, 1090
Contact: Juan Diaz 52-55-5481-9825
Peru, Lima
Merck Sharp & Dohme, Peru S.R.L.	Recruiting
Surquillo, Lima, Peru, LIMA 34
Contact: Jorge Vinces 511-411-5933
Philippines
Merck Sharp & Dohme (I.A.) Corporation	Recruiting
Makati City, Philippines, 1229
Contact: Cesar "Butch" Recto II 632-885-0700
Romania
MSD Bucharest	Recruiting
Bucharest, Romania, Sector 1
Contact: Marius R. Ursa 4021 316 8353
Russian Federation
Merck Sharp & Dohme IDEA, Inc.	Recruiting
Moscow, Russian Federation, 121059
Contact: Tatiana Serebriakova 7-495-941-8264
Sweden
Merck Sharp & Dohme (Sweden) AB	Recruiting
Sollentuna, Sweden, 192 07
Contact: Roger Juhlin 46-8-626-1 458
Thailand
MSD (Thailand) Ltd.	Recruiting
Bangkok, Thailand, 10330
Contact: Suchai Kitsiripornchai 66-2-255-5090
Turkey, Istanbul
Merck Sharp & Dohme Ilaclari Ltd. Sti	Recruiting
Istinye, Istanbul, Turkey, 34460
Contact: Meltem Telaferli 90 212 365 5354

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_549, MK0431-063
Study First Received:	July 27, 2007
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00509262 History of Changes
Health Authority:	United States: Food and Drug Administration

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 November 27, 2009