Type2 DiabetesPhase 4NCT03910361
Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
A Phase 4 study testing Evogliptin and Pioglitazone in people with Type2 Diabetes and Non-Alcoholic Fatty Liver Disease, run by Dong-A ST Co., Ltd. at 7 sites in South Korea.
Trial summary
A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Type2 Diabetes, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Evogliptin and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 12 Apr 2019to 2 Jul 2020
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II diabetes mellitus
- Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening
- Subjects with 6.5%≤HbA1c≤9.0% at screening
- Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Who cannot join
- Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- AST > upper normal range*3
- Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones
- Pregnant women
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Samsung Medical Center
Changwon
Soonchunhyang University Hospital
Cheonan
Keimyung Dongsan University Medical Center
Daegu
Hanyang University Guri Hospital
Guri-si
Catholic University of Seoul ST.Mary's Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
About this study
Official title: A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases
Read the detailed description
- Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks
- Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks
- Conditions
- Type2 Diabetes, Non-Alcoholic Fatty Liver Disease
- Being tested
- Evogliptin, Pioglitazone
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvogliptinDrug
Also called Suganon
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
PioglitazoneDrug
Also called Gluconon
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
| Study group | Role | What they receive |
|---|---|---|
| Evogliptin | Experimental | evogliptin 5mg Receives: Drug: Evogliptin |
| Pioglitazone | Active comparator | pioglitazone 15mg Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline intrahepatic fat (%)
Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start12 Apr 2019
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byung Wan Lee, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910361
- Sponsor's protocol ID
- DA1229_NAFLD_IV
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
- ClinicalTrials.gov ID
- NCT03910361
- Acronym / sponsor ID
- DA1229_NAFLD_IV
- Conditions
- Type2 Diabetes, Non-Alcoholic Fatty Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 10 Apr 2019 (actual)
- 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 multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases
Detailed description
- Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks
- Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks
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 |
| Pioglitazone | Active comparator | Drug: Pioglitazonepioglitazone 15mg |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type II diabetes mellitus
- Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening
- Subjects with 6.5%≤HbA1c≤9.0% at screening
- Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Key exclusion criteria (5 listed)
- Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- AST > upper normal range*3
- Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones
- Pregnant women
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 |
|---|---|---|
| EvogliptinAlso: Suganonevogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd | Drug | Evogliptin |
| PioglitazoneAlso: Glucononpioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd | Drug | Pioglitazone |
Primary outcome
Changes from baseline intrahepatic fat (%)
Time frame: 24 weeks
Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone
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 29 Apr 2021.
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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.
Byung Wan Lee principal investigator
Severance Hospital
7 sites 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 Pioglitazone in people with Type2 Diabetes and Non-Alcoholic Fatty Liver Disease, run by Dong-A ST Co., Ltd. at 7 sites 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 4 inclusion and 5 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 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Changes from baseline intrahepatic fat (%) (time frame: 24 weeks). 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 29 Apr 2021.