Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

Study Overview
=================
Brief Summary
-----------------
Explore pharmacodynamics glucose insulin C-peptide glucagon intact GLP-1 DPP-4 activity CGMS (continuous glucose monitoring system) Assess Safety adverse events clinical laboratory test physical examination

Detailed Description
-----------------
Pharmacodynamic assessment CGMS data is obtained from day 1 to day 3 (48 hours) PD is measured before (day 1) and after drug administration (day 2) AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity MAGE (mean amplitude of glycemic excursion) from CGMS data

Official Title
-----------------
Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Sitagliptin
* Drug: Mitiglinide
* Drug: Sitagliptin, Mitiglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with type 2 diabetes mellitus 6.5% ≤ HbA1c < 9.0% Stopped treatment of sulfonylurea and biguanide for more than 8 weeks Stopped treatment of other anti-diabetic agents for more than 12 weeks 16 kg/m2 ≤ body mass index < 30 kg/m2 Exclusion Criteria: Fasting glucose ≥ 200 mg/dL Required insulin therapy Patients with neuropathy, retinopathy or renopathy Contraindicated for mitiglinide or sitagliptin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin<br> | Drug: Sitagliptin<br>* Single oral administration of sitagliptin 100 mg<br>|
| Active Comparator: Mitiglinide<br> | Drug: Mitiglinide<br>* Single oral administration of mitiglinide 10 mg<br>|
| Experimental: Sitagliptin + Mitiglinide<br> | Drug: Sitagliptin, Mitiglinide<br>* Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the curve) of plasma glucose | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period | 
| AUC of insulin | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period | 
| AUC of intact GLP-1 | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period | 
| AUC of C-peptide | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period | 
| AUC of glucagon | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period | 
| MAGE | Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period | 
| AUC of DPP-4 activity | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups | day 1 and day 2 of each period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sitagliptin, mitiglinide, type 2 diabetes mellitus, Pharmacodynamics, Safety