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

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ClinicalTrials.gov Identifier: NCT00482079
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 743 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : May 13, 2003
Actual Primary Completion Date : August 25, 2004
Actual Study Completion Date : June 15, 2006

Resource links provided by the National Library of Medicine





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

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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482079


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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482079     History of Changes
Other Study ID Numbers: 0431-010
2007_578
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action