Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

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

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

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

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