A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888238
• Other study ID #: 0431-179
• Secondary ID: 2009_584CTRI/200
• Status: Completed
• Phase: Phase 1
• Start date: May 12, 2009
• Est. completion date: July 21, 2009

Study information

• Verified date: March 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 21, 2009
• Est. primary completion date: June 10, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sitagliptin
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
• Comparator: Placebo
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	190 minutes to 340 minutes
Secondary	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).	190 minutes to 340 minutes

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site