Back to resultsA Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sitagliptin phosphate
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Participants with T2DM failing metformin monotherapy
- Between the ages of 18 and 79
Exclusion Criteria:
- Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sitagliptin
Arm Description
Sitagliptin as add-on therapy to a stable dose of metformin
Outcomes
Primary Outcome Measures
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.
Secondary Outcome Measures
Change From Baseline in Fasting Plasma Glucose at Week 4
Calculated as the mean change from baseline in fasting plasma glucose at Week 4.
Full Information
NCT ID
NCT01034111
First Posted
December 16, 2009
Last Updated
April 28, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01034111
Brief Title
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
Official Title
An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2010 (Actual)
Primary Completion Date
October 4, 2010 (Actual)
Study Completion Date
October 4, 2010 (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
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Sitagliptin as add-on therapy to a stable dose of metformin
Intervention Type
Drug
Intervention Name(s)
Sitagliptin phosphate
Other Intervention Name(s)
MK-0431, Januvia
Intervention Description
Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
Primary Outcome Measure Information:
Title
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
Description
Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose at Week 4
Description
Calculated as the mean change from baseline in fasting plasma glucose at Week 4.
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with T2DM failing metformin monotherapy
Between the ages of 18 and 79
Exclusion Criteria:
Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
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
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
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