Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

Samsung Medical Center

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Mitiglinide; Drug: Sitagliptin; Drug: Sitagliptin, Mitiglinide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01422590

2010-04-071

Details and patient eligibility

About

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

Full 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

Enrollment: 26 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Sitagliptin

Active Comparator group

Treatment:

Drug: Sitagliptin

Mitiglinide

Active Comparator group

Treatment:

Drug: Mitiglinide

Sitagliptin + Mitiglinide

Experimental group

Treatment:

Drug: Sitagliptin, Mitiglinide