Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin; Drug: Mitiglinide; Drug: Sitagliptin, Mitiglinide

• Registration Number: NCT01422590
• Lead Sponsor: Samsung Medical Center

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

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sitagliptin	Sitagliptin	-
Mitiglinide	Mitiglinide	-
Sitagliptin + Mitiglinide	Sitagliptin, Mitiglinide	-

Primary Outcome Measures

Name	Time	Method
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 (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 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
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
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 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 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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of