Back to resultsThe Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
Primary Purpose
Diabetes Mellitus Non-insulin-dependent
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
sitagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Non-insulin-dependent
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
sitagliptin
Outcomes
Primary Outcome Measures
Change From Baseline in HbA1c (Hemoglobin A1c) at 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00832624
First Posted
January 28, 2009
Last Updated
April 27, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00832624
Brief Title
The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Business Reasons
Study Start Date
November 26, 2008 (Actual)
Primary Completion Date
September 2, 2009 (Actual)
Study Completion Date
September 2, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Non-insulin-dependent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
sitagliptin
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Other Intervention Name(s)
Januvia, MK0431
Intervention Description
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18
Description
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.
Time Frame
Baseline and Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
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