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Type2 Diabetes MellitusPhase 2DA1229NCT03667300

Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency

A Phase 2 study testing Evogliptin and Linagliptin in people with Type2 Diabetes Mellitus and Albuminuria, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
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
209 participants
Where
1 siteSouth Korea
Study dates
16 Mar 2017to 14 May 2019
Phase
Phase 2
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

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

Official 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

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.

Read the detailed description

This is a multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study. Evogliptin (Trade name, Suganon) is a new, novel dipeptidyl peptidase-4 (DPP4) inhibitor which reveals a favorable results on glucose-lowering effect in patients with diabetes. However, its effect on renal function in patients with diabetes has been uncertained. To compare the effect of evogliptin and linagliptin on the reduction of albuminuria, we will recruit a total of 210 patients with Type 2 diabetes and renal insufficiency and allocate the participants into evogliptin group and linagliptin group with a ratio of 1:1 after radomization from 10 hospitals. After the oral administration of evogliptin 5mg per day or linagliptin 5mg per day for 24 weeks, the percent change of urine albumin-to-creatinine ratio (UACR) at Week 24 and at baseline will be measured as a primary endpoint. In addition, the percent changes of UACR, hemoglobin A1c, Cystatin-C, Nephrin, N-acetyl-beta-D-glucosaminidase (NAG), glycated albumin, estimated glomerular filtration rate (eGFR) between baseline and Week 12 or Week 24 will be studied as secondary endpoints.

Being tested
Evogliptin, Linagliptin
Keywords
Type2 Diabetes Mellitus, Intervention, Albuminuria
Medical subject headings
Albuminuria, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvogliptinDrug

    Also called Suganon

    This group will take daily evogliptin 5mg per oral, not linagliptin.

  • LinagliptinDrug

    Also called Trajenta

    This group will take daily linagliptin 5mg per oral, not evogliptin

Study groups in NCT03667300
Study groupRoleWhat they receive
Evogliptin GroupActive comparatorIntervention group will take daily evogliptin 5mg per oral, not linagliptin 5mg per oral
Receives: Drug: Evogliptin
Linagliptin GroupActive comparatorControl group will take daily linagliptin 5mg per oral, not evogliptin 5mg per oral
Receives: Drug: Linagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UACR percent change at Week 24

    Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)

    Measured: Week 24

Secondary outcomes (18)

  1. UACR change at Week 24 (%)

    Change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)

    Measured: Week 24

  2. UACR change at Week 12

    Change in urine albumin-to-creatinine ratio (UACR) after 12 weeks compared to baseline (mg/g

    Measured: Week 12

  3. HbA1c change at Week 24

    Change in glycated hemoglobin after 24 weeks compared to baseline

    Measured: Week 24

  4. HbA1c change at Week 12

    Change in glycated hemoglobin after 12 weeks compared to baseline

    Measured: Week 12

  5. HbA1c less than 6.5% at Week 24

    proportion of parcipitants having glycated hemoglobin less than 6.5% after 24 weeks

    Measured: Week 24

  6. HbA1c less than 6.5% at Week 12

    proportion of participants having glycated hemoglobin less than 6.5% after 12 weeks

    Measured: Week 12

  7. HbA1c less than 7.0% at Week 24

    proportion of participants having glycated hemoglobin less than 7.0% after 24weeks

    Measured: Week 24

  8. HbA1c less than 7.0% at Week 12

    proportion of participants having glycated hemoglobin less than 7.0% after 12 weeks

    Measured: Week 12

  9. NAG (N-acetyl-β-D-glucosaminidase) change at Week 24

    Change in NAG (N-acetyl-β-D-glucosaminidase) after 24 weeks compared to baseline (U/L)

    Measured: Week 24

  10. NAG (N-acetyl-β-D-glucosaminidase) change at Week 12

    Change in NAG (N-acetyl-β-D-glucosaminidase) after 12 weeks compared to baseline (U/L)

    Measured: Week 12

  11. Cystatin-C change at Week 24

    Change in urinary Cystatin-C after 24 weeks compared to baseline (mg/L)

    Measured: Week 24

  12. Cystatin-C change at Week 12

    Change in urinary Cystatin-C after 12 weeks compared to baseline (mg/L)

    Measured: Week 12

  13. Nephrin change at Week 24

    Change in Nephrin after 24 weeks compared to baseline (ug/g cr)

    Measured: Week 24

  14. Nephrin change at Week 12

    Change in Nephrin after 12 weeks compared to baseline (ug/g cr)

    Measured: Week 12

  15. Glycated albumin change at Week 24

    Change in Glycated albumin after 24 weeks compared to baseline (%)

    Measured: Week 24

  16. Glycated albumin change at Week 12

    Change in Glycated albumin after 12 weeks compared to baseline (%)

    Measured: Week 12

  17. 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)

    Measured: Week 24

  18. 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)

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start16 Mar 2017
  3. Primary completion14 May 2019
  4. Study completion14 May 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667300
Sponsor's protocol ID
2016-08-144
Acronym
DA1229
Status last verified
Sep 2019
First submitted
20 Feb 2018
Last updated
23 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evogliptin and Linagliptin in people with Type2 Diabetes Mellitus and Albuminuria, run by Samsung Medical Center 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 7 inclusion and 8 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 Sep 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

UACR percent change at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667300.

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 Sep 2019.

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