Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4 inhibitor

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

Details

• Lead Sponsor: The Catholic University of Korea
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Type 2 diabetic patients with less than 15 yrs of disease duration

• BMI between 22-27 kg/m2

• HbA1c ≤ 9% at recruitment

1. Study group

After change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy

1. Increase of fasting blood glucose over 20 mg/dL or postprandial glucose over 30 mg/dL within several days or

2. Increase of HbA1c over 1% within 2-3 months without abrupt increase of blood glucose levels within several days

• Sulfonylurea dose : less than glimepiride 4mg or gliclazide 120mg or glibenclamide 10mg

• Metformin dose : 500~2000mg

3. Reduced response to sitagliptin should be made a decision by investigators after understanding the condition of patients surely.

2. Control group

• Age, sex, BMI matched patients with same condition of study patients

• After change sulfonylurea to sitagliptin in case of metformin plus sulfonylurea therapy, no change of blood glucose levels like above or stable HbA1c change within 1% within 2-3 months

Exclusion Criteria:

• Other causes of increase of blood glucose levels except drug change

• Patients with history of insulin treatment

• Patients taking thiazolidinediones, alpha-glucosidase inhibitors, GLP-1 analogue or DPP-4 inhibitors

• Patients with renal, hepatic dysfunction

• Patients with diabetic complications such as coronary heart disease, cerebrovascular disease, proliferative diabetic retinopathy or diabetic gastroparesis

• Patients taking medications affecting glucose level