Back to resultsA Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
sitagliptin
Comparator: Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Subject is an Asian Indian male between 18 to 45 years of age
- Subject is in good health
- Subject is a nonsmoker or has not used nicotine-containing products for six months
- Subject is willing to avoid strenuous activity
Exclusion Criteria:
- Subject has a history of stroke, seizures, or major neurological disorders
- Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
- Subject has a history of high blood pressure requiring treatment
- Subject has history of cancer
- Subject has a history of diabetes
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Sitagliptin/Sitagliptin/Placebo
Sitagliptin/Placebo/Sitaglipitin
Placebo/Sitagliptin/Sitagliptin
Arm Description
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Outcomes
Primary Outcome Measures
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
Secondary Outcome Measures
Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00888238
Brief Title
A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
Official Title
A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 12, 2009 (Actual)
Primary Completion Date
June 10, 2009 (Actual)
Study Completion Date
July 21, 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
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
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
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin/Sitagliptin/Placebo
Arm Type
Experimental
Arm Description
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Arm Title
Sitagliptin/Placebo/Sitaglipitin
Arm Type
Experimental
Arm Description
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Arm Title
Placebo/Sitagliptin/Sitagliptin
Arm Type
Experimental
Arm Description
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Other Intervention Name(s)
sitagliptin phosphate, MK0431
Intervention Description
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
Primary Outcome Measure Information:
Title
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
Description
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
Time Frame
190 minutes to 340 minutes
Secondary Outcome Measure Information:
Title
Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
Description
Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).
Time Frame
190 minutes to 340 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is an Asian Indian male between 18 to 45 years of age
Subject is in good health
Subject is a nonsmoker or has not used nicotine-containing products for six months
Subject is willing to avoid strenuous activity
Exclusion Criteria:
Subject has a history of stroke, seizures, or major neurological disorders
Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
Subject has a history of high blood pressure requiring treatment
Subject has history of cancer
Subject has a history of diabetes
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
Citations:
PubMed Identifier
29138226
Citation
Shankar SS, Shankar RR, Mixson LA, Miller DL, Steinberg HO, Beals CR, Kelley DE. Insulin secretory effect of sitagliptin: assessment with a hyperglycemic clamp combined with a meal challenge. Am J Physiol Endocrinol Metab. 2018 Apr 1;314(4):E406-E412. doi: 10.1152/ajpendo.00238.2017. Epub 2017 Nov 14.
Results Reference
result
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A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
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