Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: JW Pharmaceutical
• Treatments: Mitiglinide; Sitagliptin Phosphate

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