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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00106704
First received: March 29, 2005
Last updated: March 13, 2014
Last verified: March 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: March 2005
Study Completion Date: January 2007
Primary Completion Date: June 2006 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106704

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00106704     History of Changes
Other Study ID Numbers: 0431-035, 2005_009
Study First Received: March 29, 2005
Results First Received: November 19, 2010
Last Updated: March 13, 2014
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014