Type2 DiabetesPhase 4NCT02974504
Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)
A Phase 4 study testing evogliptin and Linagliptin in people with Type2 Diabetes, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- evogliptin and Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul
About this study
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
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
Read the 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
- Conditions
- Type2 Diabetes
- Being tested
- evogliptin, Linagliptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evogliptinDrug
evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
LinagliptinDrug
Also called Tragenta
linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
| Study group | Role | What they receive |
|---|---|---|
| evogliptin | Experimental | evogliptin 5mg qd Receives: Drug: evogliptin |
| linagliptin | Active comparator | linagliptin 5mg qd Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
unit: %
Measured: Change from baseline at 12 week
Secondary outcomes (2)
fasting plasma glucose
unit : mg/dL
Measured: Change from baseline at 12 week
HbA1c response rate
unit: %
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974504
- Sponsor's protocol ID
- DA1229_DM_IV
- Status last verified
- Jul 2018
- First submitted
- 23 Nov 2016
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02974504
- Acronym / sponsor ID
- DA1229_DM_IV
- Conditions
- Type2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| evogliptin | Experimental | Drug: evogliptinevogliptin 5mg qd |
| linagliptin | Active comparator | Drug: Linagliptinlinagliptin 5mg qd |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with 7.0%≤HbA1c≤10.0% at screening
- Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evogliptinevogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg | Drug | evogliptin |
| LinagliptinAlso: Tragentalinagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg | Drug | linagliptin |
Primary outcome
HbA1c
Time frame: Change from baseline at 12 week
unit: %
2 secondary outcomes
fasting plasma glucose
Time frame: Change from baseline at 12 week
HbA1c response rate
Time frame: Change from baseline at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing evogliptin and Linagliptin in people with Type2 Diabetes, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Change from baseline at 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.