The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832624
Recruitment Status : Terminated (Business Reasons)
First Posted : January 30, 2009
Results First Posted : October 11, 2010
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Non-insulin-dependent Drug: sitagliptin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Non Placebo-Controlled Study To Verify the Effect of Sitagliptin In Adult Patients With Type 2 Diabetes and Inadequate Glycemic Control
Actual Study Start Date : November 26, 2008
Actual Primary Completion Date : September 2, 2009
Actual Study Completion Date : September 2, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: sitagliptin
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
Other Names:
  • Januvia
  • MK0431

Primary Outcome Measures :
  1. Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18 [ Time Frame: Baseline and Week 18 ]
    Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

    • Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)
    • Or On A Single AHa

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 identifier (NCT number): NCT00832624

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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00832624     History of Changes
Other Study ID Numbers: 0431-118
First Posted: January 30, 2009    Key Record Dates
Results First Posted: October 11, 2010
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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