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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin; Drug: evogliptin

• Registration Number: NCT02949193
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-02-23
• Primary Completion: 2014-11
• Study Completion: 2015-05
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-27
• Last Update Submitted: 2016-10-27
• Study First Posted: 2016-10-31
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sitagliptin	Sitagliptin	sitagliptin 100mg qd add-on to metformin
evogliptin	evogliptin	evogliptin 5mg qd add-on to metformin

Primary Outcome Measures

Name	Time	Method
HbA1c	Change from baseline at 24 week	unit: %

Secondary Outcome Measures

Name	Time	Method
fasting plasma glucose	Change from baseline at 24 week	unit : mg/dL
HOMA-beta	Change from baseline at 24 week	unit: %
HbA1c response rate	Change from baseline at 24 weeks	unit: %

Trial Locations

Locations (1)

Kangbuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of