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

Show 22 Study Locations

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 Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_549, MK0431-063
Study First Received:	July 27, 2007
Last Updated:	January 27, 2010
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 February 08, 2010