Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
NCT ID: NCT03910361
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
51 participants
INTERVENTIONAL
2019-04-12
2020-07-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin
NCT02946541
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin
NCT06571591
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg
NCT02753803
A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
NCT04885712
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
NCT03985293
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Evogliptin
evogliptin 5mg
Evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
Pioglitazone
pioglitazone 15mg
Pioglitazone
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
Pioglitazone
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
19 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Byung Wan Lee
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Samsung Medical Center
Changwon, , South Korea
Soonchunhyang University Hospital
Cheonan, , South Korea
Keimyung Dongsan University Medical Center
Daegu, , South Korea
Hanyang University Guri Hospital
Guri-si, , South Korea
Catholic University of Seoul ST.Mary's Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DA1229_NAFLD_IV
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.