Study on Exploring the Effect of DPP-4 Inhibitors on β-cell Function by Using the Two-step Hyperglycemic Clamp

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to explore the effects of two DPP-4 inhibitors(Sitagliptin, Saxagliptin) on β- and α-cell function, as well as the incretin effect.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. 40-60 years old;

2. Diagnosed as T2DM according to the 1999 World Health Organization criteria within 2 years;

3. Free of any antihypoglycemia therapy ever;

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

5. Understand and voluntarily sign an informed consent document.

6. Good study compliance.

Exclusion Criteria:

1. With 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); Smokers or users of other tobacco products in the 3 months prior to screening.