Pharmacokinetics Study of DPP-4 Inhibitor to Control Type 2 Diabetes Mellitus
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Purpose
The purpose of this study is to confirm the mechanism of reduced response to DPP-IV inhibitor in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-IV inhibitor
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Sitagliptin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mechanism of Reduced Response to DPP-4 Inhibitor in Patients With Type 2 Diabetes Mellitus |
- Profile of Pharmacokinetics [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 min post-dose ] [ Designated as safety issue: No ]Area under curve(AUC tGLP-1, AUC iGLP-1, AUC tGIP)
- Profile of Pharmacokinetics [ Time Frame: 0, 15, 30, 45, 60 min post-dose ] [ Designated as safety issue: No ]Area under curve (DPP-4)
| Estimated Enrollment: | 24 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: study group
sitagliptin hypo-response patients
|
Drug: Sitagliptin
Sitagliptin (100mg, per oral) once a day.
Other Name: Januvia
|
|
Sham Comparator: control group
sitagliptin response patients
|
Drug: Sitagliptin
Sitagliptin (100mg, per oral) once a day.
Other Name: Januvia
|
Detailed Description:
Sitagliptin, a DPP-IV 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 mg once daily with metformin was similar to sulfonylurea (glipizide) with metformin in lowering HbA1c. Mostly in practice, stable blood glucose levels were maintained after change of sulfonylurea to sitagliptin in type 2 diabetes treatment. However, in some cases, there were abrupt severe hyperglycemia and uncontrolled blood glucose level after drug change to sitagliptin.
Several mechanism could be considered for reduced response to DPP-IV inhibitor in some type 2 diabetes patients. Firstly, significantly reduced secretion of GLP-1 more than expected in diabetes or functional defect of GLP-1 activity could be the mechanism of loss of GLP-1 effect irrespective of DPP-IV. Secondly, mutation or functional defect of DPP-IV enzyme could not be inhibited by DPP-VI inhibitor. Thirdly, GLP-1 receptor mutation or other defect in β-cell responsiveness to GLP-1 leads to reduction of response to DPP-IV inhibitor.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- Other causes of increase of blood glucose levels except drug change
- Patients with history of insulin treatment
- Patients taking TZDs, alpha-glucosidase inhibitors, GLP-1 analogue or DPP-IV inhibitors
- Patients with renal, hepatic dysfunction
- Patients with diabetic complications such as CHD, CVD, PDR or diabetic gastroparesis
- Patients taking medications affecting glucose level
Contacts and Locations| Contact: Ji Hyun Kim, M.D. | 82-2-961-4534 | kjhyun@catholic.ac.kr |
| Contact: Kun Ho Yoon, M.D., Ph.D. | 82-2-2258-7573 | yoonk@catholic.ac.kr |
| Korea, Republic of | |
| The Catholic University of Korea; St.Paul's Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 130-709 | |
| Contact: Ji Hyun Kim 82-2-961-4534 kjhyun@catholic.ac.kr | |
| Principal Investigator: Ji Hyun Kim, M.D. | |
| The Catholic University of Korea; Seoul St. Mary's Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Contact: Kun Ho Yoon 82-2-2258-7573 yoonk@catholic.ac.kr | |
| Principal Investigator: Kun Ho Yoon | |
| Principal Investigator: | Ji Hyun Kim, Dr | The Catholic University of Korea |
More Information
No publications provided
| Responsible Party: | Ji Hyun Kim, Clinical Assistant Professor, The Catholic University of Korea |
| ClinicalTrials.gov Identifier: | NCT01449747 History of Changes |
| Other Study ID Numbers: | CMCENDO-01 |
| Study First Received: | September 29, 2011 |
| Last Updated: | October 7, 2011 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by The Catholic University of Korea:
|
Type 2 diabetes mellitus Dipeptidyl peptidase IV inhibitors Glucagon-like peptide 1 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013