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Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00106704
First received: March 29, 2005
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Comparator: Sitagliptin
Drug: Comparator: Placebo
Drug: Comparator: Pioglitazone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in A1C at Week 24 [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.


Secondary Outcome Measures:
  • Change From Baseline in FPG at Week 24 [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.


Enrollment: 441
Study Start Date: April 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Sitagliptin 10 mg tablet daily for 54 weeks
 Drug: Comparator: Sitagliptin
sitagliptin 10 mg tablet, once daily for 54 weeks
Placebo Comparator: Placebo/ Pioglitazone
Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
 Drug: Comparator: Placebo
Placebo oral tablet once daily for 24 weeks
Drug: Comparator: Pioglitazone
Pioglitazone 30 mg tablet once daily for 30 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion Criteria:

  • Patients with Type 1 Diabetes Mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106704

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
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00106704     History of Changes
Other Study ID Numbers: 2005_009, MK0431-035
Study First Received: March 29, 2005
Results First Received: November 19, 2010
Last Updated: November 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Sitagliptin
 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 May 23, 2013