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A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: June 1, 2007
Last updated: August 7, 2015
Last verified: August 2015
A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.

Condition Intervention Phase
Diabetes Mellitus, Type II
Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Resource links provided by NLM:

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

Primary Outcome Measures:
  • To asses the effectiveness of MK0431 compared to placebo [ Time Frame: over 12 weeks ]

Secondary Outcome Measures:
  • To test the safety and tolerability of MK0431 in patients with type 2 diabetes

Enrollment: 743
Study Start Date: May 2003
Study Completion Date: June 2006
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 21 to 70, You are a man or non-pregnant woman

Exclusion Criteria:

  • Have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medications
  • You have a history of minor surgery
  • You have received investigational drugs within 8 weeks of study start
  • You have hepatitis B or C
  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 identifier: NCT00482079

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00482079     History of Changes
Other Study ID Numbers: 0431-010  2007_578 
Study First Received: June 1, 2007
Last Updated: August 7, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 24, 2017