A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin
- Registration Number
- NCT02946541
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.
- Detailed Description
1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks.
2. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- Subjects with 6.5%≤HbA1c≤10.0% at screening
- Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
- Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
- 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 6 months prior to screening
- Subjects with ALT and AST 2.5 times or higher than upper normal range
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Placebo QD evogliptin 5mg evogliptin 5mg evogliptin 5mg QD
- Primary Outcome Measures
Name Time Method HbA1c Change from baseline at 24 weeks unit: %
- Secondary Outcome Measures
Name Time Method HbA1c response rate Change from baseline at 24 weeks unit: %
fasting plasma glucose Change from baseline at 24 weeks unit: mg/dL
Trial Locations
- Locations (1)
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of