Back to resultsMK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate
Comparator: sitagliptin phosphate (MK0431)
Comparator: pioglitazone
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Patients Have Type 2 Diabetes Mellitus
- On Diet/Exercise Therapy And Pioglitazone As Monotherapy
Exclusion Criteria:
- Patients Have Type 1 Diabetes Mellitus
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
MK0431 + pioglitazone
Placebo/MK0431 + pioglitazone
Outcomes
Primary Outcome Measures
Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.
Secondary Outcome Measures
Change From Baseline in Fasting Plasma Glucose at Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.
Full Information
NCT ID
NCT00372060
First Posted
September 5, 2006
Last Updated
April 6, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00372060
Brief Title
MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
Official Title
MK0431 (Sitagliptin) Phase III Clinical Study -Pioglitazone add-on Study for Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 21, 2006 (Actual)
Primary Completion Date
February 5, 2008 (Actual)
Study Completion Date
February 5, 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
The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MK0431 + pioglitazone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo/MK0431 + pioglitazone
Intervention Type
Drug
Intervention Name(s)
sitagliptin phosphate
Other Intervention Name(s)
MK0431
Intervention Description
Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: sitagliptin phosphate (MK0431)
Other Intervention Name(s)
MK0431
Intervention Description
Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: pioglitazone
Intervention Description
pioglitazone once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Intervention Description
Placebo once daily for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12
Description
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose at Week 12
Description
Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.
Time Frame
12 Weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline in 2 Hour Postprandial Glucose at Week 12
Description
Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.
Time Frame
12 weeks
Title
Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52
Description
Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.
Time Frame
Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients Have Type 2 Diabetes Mellitus
On Diet/Exercise Therapy And Pioglitazone As Monotherapy
Exclusion Criteria:
Patients Have Type 1 Diabetes Mellitus
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
24843518
Citation
Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC, Amatruda JM. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011 Oct 7;2(5):381-90. doi: 10.1111/j.2040-1124.2011.00120.x.
Results Reference
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MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
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