- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974504
Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)
July 19, 2018 updated by: Dong-A ST Co., Ltd.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
207
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: evogliptin
evogliptin 5mg qd
|
evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
|
Active Comparator: linagliptin
linagliptin 5mg qd
|
linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Change from baseline at 12 week
|
unit: %
|
Change from baseline at 12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fasting plasma glucose
Time Frame: Change from baseline at 12 week
|
unit : mg/dL
|
Change from baseline at 12 week
|
HbA1c response rate
Time Frame: Change from baseline at 12 weeks
|
unit: %
|
Change from baseline at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 23, 2016
First Posted (Estimate)
November 28, 2016
Study Record Updates
Last Update Posted (Actual)
July 23, 2018
Last Update Submitted That Met QC Criteria
July 19, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Linagliptin
Other Study ID Numbers
- DA1229_DM_IV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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