Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1) - 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 participants with moderate and severe renal insufficiency.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic	Drug: Sitagliptin Drug: Glipizide Drug: Placebo for Sitagliptin Drug: Placebo for Glipizide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizidein Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Kidney Failure

Drug Information available for: Glipizide Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change in Hemoglobin A1c (HbA1c) Levels [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
Number of Hypoglycemic Events [ Time Frame: Baseline up to 54 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Weight [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]

Enrollment:	430
Study Start Date:	October 2007
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sitagliptin 25 mg Sitagliptin + Placebo for Glipizide	Drug: Sitagliptin Participants with moderate renal insufficiency will receive two 25 mg tablets per day; Participants with severe renal insufficiency will receive one 25 mg tablet daily Other Name: MK-0431 Drug: Placebo for Glipizide 2.5 mg (1/2 tablet) up to 20 mg (8 tablets) once daily
Active Comparator: Glipizide 2.5 mg - 20 mg Glipizide + Placebo for Sitagliptin	Drug: Glipizide 2.5 mg (1/2 tablet) up to 20 mg (8 tablets) once daily Other Name: Glucotrol Drug: Placebo for Sitagliptin Participants with moderate renal insufficiency will receive 2 tablets per day; Participants with severe renal insufficiency will receive 1 tablet daily

Eligibility

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

Criteria

Inclusion Criteria:

Has type 2 diabetes mellitus
Has moderate or severe renal insufficiency

Exclusion Criteria:

Has type 1 diabetes mellitus or a history of ketoacidosis
Is on a new weight loss program
Has active liver disease
Is on dialysis or is likely to need dialysis during the study

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information 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:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00509262 History of Changes
Other Study ID Numbers:	MK-0431-063, 2007_549
Study First Received:	July 27, 2007
Last Updated:	April 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

Sitagliptin
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012