Study of Comparing the Different Effect of DPP-4 Inhibitors and Sulfonylurea by Using "Biphase-Hyperglycemic Clamp"

• Status: Unknown status
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to demonstrate the different effects of two DPP-4 inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the different effects of the study drugs on the GLP-1 response, and the glucagon concentration which indicates alpha cell function in healthy subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Glimepiride; Saxagliptin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted;

2. Having good study compliance;

3. Healthy Male subjects between 20-30 years of age (inclusive), and in good health as determined by past medical history, physical examination, vital signs, and clinical laboratory test;

4. Must have a body mass index (BMI) between 19-25kg/m2 (inclusive);

5. No weight fluctuation greater than 5% in late 3 months。

Exclusion Criteria:

1. With impaired glucose tolerance, T2DM or any significant medical condition (within 3 years), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study;

2. Used any prescribed systemic or topical medication within 30 days of the first dose administration;

3. Any medical or surgical conditions possibly affecting study drug absorption, distribution, metabolism and excretion;

4. Participated in a clinical study involving administration of an investigational drug within 90 days preceding the first dose administration or within five half-lives of the first dose administration (whichever is longer);

5. Donated blood or plasma or had any other significant blood loss within 2 months preceding the first dose administration;

6. History of multiple drug allergies;

7. Any clinically significant allergic disease;

8. Recently drug or alcohol abuse (>35 unit/week, 1 unit=8g alcohol @ 1 standard drink @ 250ml beer @ 140ml wine @ 25ml strong alcohol drink like whiskey);

9. Smokers or users of other tobacco products in the 3 months prior to screening.