Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949193
• Other study ID #: DA1229_DMC_III
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2014
• Last updated: October 27, 2016
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Description:

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.

2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with 6.5%=HbA1c=11.0% at screening

• Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before 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 6 months prior to screening

• Subjects with ALT and AST 2.5 times or higher than upper normal range

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg
• Sitagliptin
sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Medical Center	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 week	No
Secondary	fasting plasma glucose	unit : mg/dL	Change from baseline at 24 week	No
Secondary	HOMA-beta	unit: %	Change from baseline at 24 week	No
Secondary	HbA1c response rate	unit: %	Change from baseline at 24 weeks	No