NCT02974504
Completed
Phase 4
A Multicenter, Randomized, Double-blind, Active-contrelled, Parallel-group, Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin After Oral Administration in Patiend With Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- evogliptin
- Conditions
- Type2 Diabetes
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- HbA1c
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV clinical trial to investigate the effect on blood glucose of evogliptin after oral administration in patients with type 2 diabetes
Detailed Description
1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks. 2. Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with Evogliptin 5mg for 13-24 weeks
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with 7.0%≤HbA1c≤10.0% at screening
- •Subjects untreated with oral hypoglycemic agents within 8 weeks prior to screening
- •Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Exclusion Criteria
- •Subjects with fasting plasma glucose≥270mg/dL at screening
- •Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- •Subjects with history of myocardial infarction, cerebral infarction within 24 weeks prior to screening
- •Subjects with ALT and AST 3 times or higher than upper normal range
Arms & Interventions
evogliptin
evogliptin 5mg qd
Intervention: evogliptin
linagliptin
linagliptin 5mg qd
Intervention: Linagliptin
Outcomes
Primary Outcomes
HbA1c
Time Frame: Change from baseline at 12 week
unit: %
Secondary Outcomes
- fasting plasma glucose(Change from baseline at 12 week)
- HbA1c response rate(Change from baseline at 12 weeks)
Study Sites (1)
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