Status:
COMPLETED
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
Lead Sponsor:
The Catholic University of Korea
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
Brief 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
Detailed Description
Sitagliptin, a DPP-4 inhibitor was used as an incretin enhancer in clinical practice first. In clinical trials, sitagliptin showed effective control of blood glucose level in type 2 diabetes and 100 m...
Eligibility Criteria
Inclusion
- Type 2 diabetic patients with less than 15 yrs of disease duration
- BMI between 22-27 kg/m2
- HbA1c ≤ 9% at recruitment
- Study group
- After change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy
- Increase of fasting blood glucose over 20 mg/dL or postprandial glucose over 30 mg/dL within several days or
- 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
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01449747
Start Date
December 1 2011
End Date
July 1 2015
Last Update
December 14 2015
Active Locations (2)
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1
The Catholic University of Korea; St.Paul's Hospital
Seoul, South Korea, 130-709
2
The Catholic University of Korea; Seoul St. Mary's Hospital
Seoul, South Korea, 137-701