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Completed

NCT Number: NCT02974504

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

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

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Key information

Conditions

Type2 Diabetes

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

About this study

  • Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks.
  • Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with Evogliptin 5mg for 13-24 weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evogliptin

Drug

evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg

Linagliptin

Drug

linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg

Other names: Tragenta

Primary outcomes

  1. HbA1c

    Time frame: Change from baseline at 12 week

    unit: %

Secondary outcomes

  1. fasting plasma glucose

    Time frame: Change from baseline at 12 week

    unit : mg/dL

  2. HbA1c response rate

    Time frame: Change from baseline at 12 weeks

    unit: %

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2016
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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