Type 2 Diabetes Mellitus
Conditions
Keywords
sitagliptin, mitiglinide, type 2 diabetes mellitus, Pharmacodynamics, Safety
Brief summary
1. Explore pharmacodynamics * glucose * insulin * C-peptide * glucagon * intact GLP-1 * DPP-4 activity * CGMS (continuous glucose monitoring system) 2. 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) 1. AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity 2. MAGE (mean amplitude of glycemic excursion) from CGMS data
Interventions
DRUGSitagliptin
Single oral administration of sitagliptin 100 mg
DRUGMitiglinide
Single oral administration of mitiglinide 10 mg
DRUGSitagliptin, Mitiglinide
Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg
Sponsors
JW Pharmaceutical
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC (area under the curve) of plasma glucose | day 1 and day 2 of each period | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups |
| AUC of insulin | day 1 and day 2 of each period | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups |
| AUC of intact GLP-1 | day 1 and day 2 of each period | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups |
| AUC of C-peptide | day 1 and day 2 of each period | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups |
| AUC of glucagon | day 1 and day 2 of each period | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups |
| MAGE | day 1 and day 2 of each period | Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups |
| AUC of DPP-4 activity | day 1 and day 2 of each period | Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups |
Countries
South Korea
Outcome results
None listed