search
Back to results

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

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
evogliptin
Linagliptin
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

evogliptin

linagliptin

Arm Description

evogliptin 5mg qd

linagliptin 5mg qd

Outcomes

Primary Outcome Measures

HbA1c
unit: %

Secondary Outcome Measures

fasting plasma glucose
unit : mg/dL
HbA1c response rate
unit: %

Full Information

First Posted
November 23, 2016
Last Updated
July 19, 2018
Sponsor
Dong-A ST Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02974504
Brief Title
Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
evogliptin
Arm Type
Experimental
Arm Description
evogliptin 5mg qd
Arm Title
linagliptin
Arm Type
Active Comparator
Arm Description
linagliptin 5mg qd
Intervention Type
Drug
Intervention Name(s)
evogliptin
Intervention Description
evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Tragenta
Intervention Description
linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
Primary Outcome Measure Information:
Title
HbA1c
Description
unit: %
Time Frame
Change from baseline at 12 week
Secondary Outcome Measure Information:
Title
fasting plasma glucose
Description
unit : mg/dL
Time Frame
Change from baseline at 12 week
Title
HbA1c response rate
Description
unit: %
Time Frame
Change from baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs