Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency (NCT03667300) | Clinical Trial Compass
CompletedPhase 2
Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency
South Korea209 participantsStarted 2017-03-16
Plain-language summary
In this multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study, we aimed to test the non-inferiority of evogliptin vs linagliptin in terms of reduction of albuminuria at week 24 from baseline in patients with type 2 diabetes having renal insufficiency.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women aged 20 years or older diagnosed with type 2 diabetes.
* subjects having a level of glycated hemoglobin (HbA1c) 7.0% or more, and 10% or less.
* subjects having urine albumin to creatinine ratio (UACR) 30 ug/mg or more, and 3000 ug/mg or less.
* subjects having estimated glomerular filtration rate (eGFR) 30 or more.
* subjects who had taken angiotensin II receptor blocker(ARB) or angiotensin-converting enzyme(ACE) inhibitors for more than 4 weeks.
* subjects having body mass index (BMI) 20kg/m2 or more, 40 kg/m2 or less.
* subjects who entirely understood all the process of clinical study protocol and voluntarily take part in the study and agree to follow rule of the study.
Exclusion Criteria:
* subjects having type 1 diabetes, secondary diabetes, or gestational diabetes
* subjects who had a history of surgery of resection of more than a half length of stomach or intestine.
* subjects having more than three-fold higher levels of Aspartate Transaminase(AST) or Alanine Transaminase(ALT) than upper normal limit.
* subjects who had taken Dipeptidyl Peptidase4(DPP4)-inhibitor or glucagon-like peptide-1(GLP-1) analogue within 8 weeks prior to screening.
* subjects who had taken oral triple hypoglycemic agents within 8 weeks prior to screening
* subjects taking strong cytochrome P450 3A4(CYP3A4) inhibitors or strong cytochrome P450 3A4(CYP3A4) inducers
* subjects who are pregnants or breast feeding givers.
* subjects who are unsuitable for clin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.