Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974504
• Other study ID #: DA1229_DM_IV
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: July 2018
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
• Linagliptin
linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg

Locations

Country	Name	City	State
Korea, Republic of	Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	unit: %	Change from baseline at 12 week
Secondary	fasting plasma glucose	unit : mg/dL	Change from baseline at 12 week
Secondary	HbA1c response rate	unit: %	Change from baseline at 12 weeks