Renal Insufficiency Clinical Trial
— DA1229Official title:
Evogliptin Versus Linagliptin for the Effect on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency: a Multicenter, Randomised, Double-blind, Active-controlled, Non-inferiority Trial
Verified date | September 2019 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 209 |
Est. completion date | May 14, 2019 |
Est. primary completion date | May 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 clinical trial participation based on clinical laboratory test results or other reasons (e.g. taking chemotherapy or radiation for treatment for cancers). |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | UACR percent change at Week 24 | Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%) | Week 24 | |
Secondary | UACR change at Week 24 (%) | Change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%) | Week 24 | |
Secondary | UACR change at Week 12 | Change in urine albumin-to-creatinine ratio (UACR) after 12 weeks compared to baseline (mg/g | Week 12 | |
Secondary | HbA1c change at Week 24 | Change in glycated hemoglobin after 24 weeks compared to baseline | Week 24 | |
Secondary | HbA1c change at Week 12 | Change in glycated hemoglobin after 12 weeks compared to baseline | Week 12 | |
Secondary | HbA1c less than 6.5% at Week 24 | proportion of parcipitants having glycated hemoglobin less than 6.5% after 24 weeks | Week 24 | |
Secondary | HbA1c less than 6.5% at Week 12 | proportion of participants having glycated hemoglobin less than 6.5% after 12 weeks | Week 12 | |
Secondary | HbA1c less than 7.0% at Week 24 | proportion of participants having glycated hemoglobin less than 7.0% after 24weeks | Week 24 | |
Secondary | HbA1c less than 7.0% at Week 12 | proportion of participants having glycated hemoglobin less than 7.0% after 12 weeks | Week 12 | |
Secondary | NAG (N-acetyl-ß-D-glucosaminidase) change at Week 24 | Change in NAG (N-acetyl-ß-D-glucosaminidase) after 24 weeks compared to baseline (U/L) | Week 24 | |
Secondary | NAG (N-acetyl-ß-D-glucosaminidase) change at Week 12 | Change in NAG (N-acetyl-ß-D-glucosaminidase) after 12 weeks compared to baseline (U/L) | Week 12 | |
Secondary | Cystatin-C change at Week 24 | Change in urinary Cystatin-C after 24 weeks compared to baseline (mg/L) | Week 24 | |
Secondary | Cystatin-C change at Week 12 | Change in urinary Cystatin-C after 12 weeks compared to baseline (mg/L) | Week 12 | |
Secondary | Nephrin change at Week 24 | Change in Nephrin after 24 weeks compared to baseline (ug/g cr) | Week 24 | |
Secondary | Nephrin change at Week 12 | Change in Nephrin after 12 weeks compared to baseline (ug/g cr) | Week 12 | |
Secondary | Glycated albumin change at Week 24 | Change in Glycated albumin after 24 weeks compared to baseline (%) | Week 24 | |
Secondary | Glycated albumin change at Week 12 | Change in Glycated albumin after 12 weeks compared to baseline (%) | Week 12 | |
Secondary | eGFR at Week 24 | Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 24 weeks compared to baseline (mL/min) | Week 24 | |
Secondary | eGFR change at Week 12 | Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 12 weeks compared to baseline (mL/min) | Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05990660 -
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
|
N/A | |
Recruiting |
NCT04096547 -
Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
|
||
Completed |
NCT04024332 -
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
|
Phase 1 | |
Completed |
NCT02849964 -
Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions
|
N/A | |
Active, not recruiting |
NCT03672110 -
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen
|
Phase 3 | |
Completed |
NCT01407874 -
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
|
Phase 2 | |
Completed |
NCT01462136 -
PK Study of ACHN-490 Injection in Renally Impaired Subjects
|
Phase 1 | |
Completed |
NCT01172431 -
Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
|
Phase 4 | |
Completed |
NCT00765830 -
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
|
Phase 3 | |
Completed |
NCT00770081 -
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
|
Phase 3 | |
Completed |
NCT01545531 -
Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance
|
N/A | |
Terminated |
NCT00338455 -
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
|
Phase 2 | |
Completed |
NCT00159614 -
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
|
Phase 2 | |
Completed |
NCT02894905 -
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335
|
Phase 1 | |
Completed |
NCT02894385 -
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
|
Phase 1 | |
Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
Not yet recruiting |
NCT03899298 -
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
|
Phase 1 | |
Completed |
NCT03235375 -
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
|
Phase 1 | |
Withdrawn |
NCT03329612 -
Remote Ischemic Preconditioning in ACS Patients
|
N/A | |
Recruiting |
NCT02578784 -
DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis
|
N/A |