Status:
COMPLETED
Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
JW Pharmaceutical
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
1. Explore pharmacodynamics * glucose * insulin * C-peptide * glucagon * intact GLP-1 * DPP-4 activity * CGMS (continuous glucose monitoring system) 2. Assess Safety * advers...
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, gluca...
Eligibility Criteria
Inclusion
- Male or female patients with type 2 diabetes mellitus
- 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
- Fasting glucose ≥ 200 mg/dL
- Required insulin therapy
- Patients with neuropathy, retinopathy or renopathy
- Contraindicated for mitiglinide or sitagliptin
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01422590
Start Date
May 1 2010
End Date
April 1 2011
Last Update
September 7 2011
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea