Type2 Diabetes
Conditions
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
Interventions
DRUGevogliptin
evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
DRUGLinagliptin
linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Change from baseline at 12 week | unit: % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fasting plasma glucose | Change from baseline at 12 week | unit : mg/dL |
| HbA1c response rate | Change from baseline at 12 weeks | unit: % |
Countries
South Korea
Outcome results
None listed