Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
Primary Purpose
Type 2 Diabetes Mellitus (T2DM)
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: sitagliptin phosphate
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus (T2DM)
Eligibility Criteria
Inclusion Criteria:
- Participant has type 2 diabetes mellitus
- Males
- Females who are highly unlikely to become pregnant
- Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications
Exclusion Criteria:
- Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
- Participant required insulin therapy within the prior 8 weeks
- Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
sitagliptin
Placebo
Arm Description
Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
Participants randomized to this arm will be administered matching placebo, daily for six weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00704132
Brief Title
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
Official Title
A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 14, 2007 (Actual)
Primary Completion Date
April 28, 2010 (Actual)
Study Completion Date
April 28, 2010 (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 clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus (T2DM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sitagliptin
Arm Type
Experimental
Arm Description
Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm will be administered matching placebo, daily for six weeks.
Intervention Type
Drug
Intervention Name(s)
Comparator: sitagliptin phosphate
Intervention Description
Sitagliptin tablet 100 mg, administered once daily before the morning meal.
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Intervention Description
Matching placebo tablet, administered once daily before the morning meal.
Primary Outcome Measure Information:
Title
Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
Description
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
Time Frame
Baseline and Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant has type 2 diabetes mellitus
Males
Females who are highly unlikely to become pregnant
Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications
Exclusion Criteria:
Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
Participant required insulin therapy within the prior 8 weeks
Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit
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
22685234
Citation
Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.
Results Reference
derived
Learn more about this trial
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
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