Back to resultsSitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate
sitagliptin phosphate
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Patient has Type 2 Diabetes
- Patient is between the ages of 30-65 years
- Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).
Exclusion Criteria:
- Patient has Type 1 Diabetes
- Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
- Patient has taken insulin within the past 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
sitagliptin 100 mg
sitagliptin 200 mg
Placebo
Outcomes
Primary Outcome Measures
24-hour Weighted Mean Glucose (WMG)
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00541229
Brief Title
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
Official Title
A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 24, 2007 (Actual)
Primary Completion Date
June 17, 2008 (Actual)
Study Completion Date
July 1, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
sitagliptin 100 mg
Arm Title
2
Arm Type
Experimental
Arm Description
sitagliptin 200 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
sitagliptin phosphate
Other Intervention Name(s)
MK0431
Intervention Description
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
Intervention Type
Drug
Intervention Name(s)
sitagliptin phosphate
Other Intervention Name(s)
MK0431
Intervention Description
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
Primary Outcome Measure Information:
Title
24-hour Weighted Mean Glucose (WMG)
Description
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.
Time Frame
Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has Type 2 Diabetes
Patient is between the ages of 30-65 years
Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).
Exclusion Criteria:
Patient has Type 1 Diabetes
Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
Patient has taken insulin within the past 3 months
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
Citations:
PubMed Identifier
19691426
Citation
Alba M, Sheng D, Guan Y, Williams-Herman D, Larson P, Sachs JR, Thornberry N, Herman G, Kaufman KD, Goldstein BJ. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009 Oct;25(10):2507-14. doi: 10.1185/03007990903209514.
Results Reference
derived
Learn more about this trial
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
We'll reach out to this number within 24 hrs