A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946541
• Other study ID #: DA1229_DMM_III
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2014
• Last updated: March 26, 2017
• Start date: July 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2017
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• evogliptin 5mg
evogliptin 5mg, QD
• Placebo
Placebo, QD

Locations

Country	Name	City	State
Korea, Republic of	Kangdong Sacred Heart Hospital	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 24 weeks
Secondary	fasting plasma glucose	unit: mg/dL	Change from baseline at 24 weeks
Secondary	HbA1c response rate	unit: %	Change from baseline at 24 weeks