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Diabetic NephropathiesPhase 4NCT02690883

Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy

A Phase 4 study testing Exenatide and Lispro in people with Diabetic Nephropathies, run by Nanfang Hospital, Southern Medical University.

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

This is a multi-center, randomized, parallel study to evaluate effect of exenatide on 24h-UAER in patients with diabetic nephropathy. Screening will be made to select eligible participants before intervention. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Diabetic Nephropathies
What is being tested?
Exenatide and Lispro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
No sites listed yet
Study dates
8 Apr 2016to 30 Dec 2019
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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures.
  • Diagnosed with type 2 diabetes with HbA1c ≥ 7.0% and ≤ 11.0% at screening (the result is valid for seven days).
  • Men and women (non-pregnant and using a medically approved birth-control method) aged from 18 to 80 at screening.
  • Body mass index (BMI) ≥18 and ≤35 kg/m2.
  • Blood Pressure (BP) ≥ 90/60mmHg and ≤160/100mmHg.
  • 6.24h urinary albumin excretion rate (UAE) >0.3g/24h after 3 months treatment with several hypoglycemic agents (sulphonylureas, metformin, AG-inhibitor, meglitinides or insulin), ACEI/ARB and salt restriction(the result is valid for seven days).
  • 7.eGFR >30ml/min(the result is valid for seven days).

Who cannot join

  • 1．Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
  • 2. Diagnosis or history of:
  • Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
  • Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
  • 3. Previous treatment with any Thiazolidinediones (TZDs), dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past 3 months.
  • 4. History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to exenatide.
Show all 16Show fewer
  • 5. Blood amylase and/or lipase > 2 times the upper limit of the normal (ULN) laboratory range.
  • 6. Hyperkalemia (K+>5.5mmol/L).
  • 7. eGFR <30ml/min/1.73m2.
  • 8. Patients without diabetic retinopathy.
  • 9. Triglycerides (fasting) > 4.5 mmol/L (400 mg/dL) at screening or within 4 weeks prior to screening (by local laboratory).
  • 10. Patients with clinically apparent liver disease characterized by ALT or AST > 3ULN confirmed on two consecutive measurements (by local laboratory) within 4 weeks prior to screening period.
  • 11. Significant cardiovascular history within the past 3 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.
  • 12. Congestive heart failure defined as New York Heart Association (NYHA) class III or IV.
  • 13. History of chronic pancreatitis or idiopathic acute pancreatitis.
  • 14. History of medullary thyroid carcinoma.

About this study

Official title: Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy: a 24- Week Study

This is a multi-center, randomized, parallel study to evaluate effect of exenatide on 24h-UAER in patients with diabetic nephropathy.

Screening will be made to select eligible participants before intervention. The trial will include 2-week run-in period of stable doses of glargine plus lispro insulin and 24-week treatment period. After the run-in period, patients were randomly assigned to one of two groups for antihyperglycaemic therapies for a total of 24-weeks: glargine plus exenatide and continued glargine plus lispro insulin. The treatment of exenatide will be initiated by 5ug bid, and uptitrated to 10 ug bid after 4 weeks and then maintained at 10ug bid until the completion of the study. Lispro insulin will be initially treated according to the insulin dosage of previous antihyperglycaemic therapies, and further titrated up at 4-week intervals until to reach the target fasting blood glucose (FPG).

Read the detailed description

Objective:

To evaluate effect of exenatide on 24-UAER in patients with diabetic nephropathy

Hypothesis:

Compared with glargine plus lispro group, at 24 weeks, glargine plus exenatide group can: 1) take more significant reduction of 24h-UAER; 2) take more reduction of ACR; 3) take more weight loss, blood pressure reduction; 4) take lower hypoglycemia incidence and less insulin dosage.

Primary endpoint： The proportion of reduction of 24h-UAER(urinary albumin excretion rates)

Secondary endpoints： 24h-UAER at 24 weeks; the rate of urinary albumin to creatinine ratio(ACR) change at 24 weeks; HbA1c, FPG,PPG, weight , BP

Treatment duration： 24weeks

Patient/Sites： 90 patients / 3 sites

Timeline (best case)： Planed duration of recruitment period: 6 month Planed date for first screening: 1 October 2015 Planed completion of the last subject: 1 March 2017 Planned completion of clinical trial report: 30 October 2017

Being tested
Exenatide, Lispro
Medical subject headings
Diabetic Nephropathies

What participants receive

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

  • ExenatideDrug

    Also called Byetta

    Exenatide (Astrazeneca ) 5 μg(initial dose)/10ug(maintenance dose) Subcutaneous injection Bid

  • LisproDrug

    Also called Humalog

    Lispro (Eli Lilly), the dosage is initiated according to the previous treatment plan and weight of the patients, distribute the dosage to 1:1:1 before 3 meals, titration following PPG <10.0mmol/L.

Study groups in NCT02690883
Study groupRoleWhat they receive
LisproActive comparatorPatients are treated with Glargine (Lantus, Sanofi-Aventis), the dosage is initiated according to the previous treatment plan and weight of the patients, injection before bed time, titration following FPG <7.2mmol/L and >4.4mmol/L.
Receives: Drug: Lispro
ExenatideExperimentalPatients are treated with Glargine (Lantus, Sanofi-Aventis), the dosage is initiated according to the previous treatment plan and weight of the patients, injection before bed time, titration following FPG <7.2mmol/L and >4.4mmol/L.
Receives: Drug: Exenatide

What is being measured

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

  1. the percentage change of 24h-UAER(urinary albumin excretion rates) from baseline at Week 24

    the percentage change of 24h-UAER=(24h-UAERweek24 - 24h-UAERbaseline)/ 24h-UAERbaseline

    Measured: from baseline at Week 24

Secondary outcomes (6)

  1. the percentage change of ACR

    the percentage change of ACR=(ACRweek24 - ACRbaseline)/ ACRbaseline

    Measured: from baseline at Week 24

  2. Change in 24h-UAER

    Change in 24h-UAER =24h-UAERweek24 - 24h-UAERbaseline

    Measured: from baseline at Week 24

  3. Change in HbA1c

    Change in HbA1c=HbA1cweek24-HbA1cbaseline

    Measured: from baseline at Week 24

  4. Change in FPG

    Change in FPG=FPGweek24-FPGbaseline

    Measured: from baseline at Week 24

  5. Change in Weight

    Change in weight=Weightweek24-Weightbaseline

    Measured: from baseline at Week 24

  6. Change in Blood pressure

    Change in blood pressure=SBPweek24-SBPbaseline

    Measured: from baseline at Week 24

Timeline

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

  1. First posted24 Feb 2016 (estimated)
  2. Study start8 Apr 2016
  3. Primary completion13 Dec 2019
  4. Study completion30 Dec 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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02690883
Sponsor's protocol ID
ESR-14-10425
Status last verified
Mar 2020
First submitted
20 Feb 2016
Last updated
9 Mar 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.

    PubMed 17276798

  • Lim AKh. Diabetic nephropathy - complications and treatment. Int J Nephrol Renovasc Dis. 2014 Oct 15;7:361-81. doi: 10.2147/IJNRD.S40172. eCollection 2014.

    PubMed 25342915

  • de Zeeuw D, Parving HH, Henning RH. Microalbuminuria as an early marker for cardiovascular disease. J Am Soc Nephrol. 2006 Aug;17(8):2100-5. doi: 10.1681/ASN.2006050517. Epub 2006 Jul 6.

    PubMed 16825327

  • Filippatos TD, Elisaf MS. Effects of glucagon-like peptide-1 receptor agonists on renal function. World J Diabetes. 2013 Oct 15;4(5):190-201. doi: 10.4239/wjd.v4.i5.190.

    PubMed 24147203

  • Lu B, Song X, Dong X, Yang Y, Zhang Z, Wen J, Li Y, Zhou L, Zhao N, Zhu X, Hu R. High prevalence of chronic kidney disease in population-based patients diagnosed with type 2 diabetes in downtown Shanghai. J Diabetes Complications. 2008 Mar-Apr;22(2):96-103. doi: 10.1016/j.jdiacomp.2007.08.001.

    PubMed 18280439

  • Lai X, Zhang AH, Chen SY, He L, Su CY, Fan MH, Wang T. Outcomes of stage 1-5 chronic kidney disease in Mainland China. Ren Fail. 2014 May;36(4):520-5. doi: 10.3109/0886022X.2013.875859. Epub 2014 Jan 23.

    PubMed 24456114

  • Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

    PubMed 8366922

  • Tomino Y. Pathogenesis and treatment of chronic kidney disease: a review of our recent basic and clinical data. Kidney Blood Press Res. 2014;39(5):450-89. doi: 10.1159/000368458. Epub 2014 Nov 30.

    PubMed 25501571

  • Kobori H, Mori H, Masaki T, Nishiyama A. Angiotensin II blockade and renal protection. Curr Pharm Des. 2013;19(17):3033-42. doi: 10.2174/1381612811319170009.

    PubMed 23176216

  • Park CW, Kim HW, Ko SH, Lim JH, Ryu GR, Chung HW, Han SW, Shin SJ, Bang BK, Breyer MD, Chang YS. Long-term treatment of glucagon-like peptide-1 analog exendin-4 ameliorates diabetic nephropathy through improving metabolic anomalies in db/db mice. J Am Soc Nephrol. 2007 Apr;18(4):1227-38. doi: 10.1681/ASN.2006070778. Epub 2007 Mar 14.

    PubMed 17360951

  • Xu WW, Guan MP, Zheng ZJ, Gao F, Zeng YM, Qin Y, Xue YM. Exendin-4 alleviates high glucose-induced rat mesangial cell dysfunction through the AMPK pathway. Cell Physiol Biochem. 2014;33(2):423-32. doi: 10.1159/000358623. Epub 2014 Feb 11.

    PubMed 24556697

  • Zhang H, Zhang X, Hu C, Lu W. Exenatide reduces urinary transforming growth factor-beta1 and type IV collagen excretion in patients with type 2 diabetes and microalbuminuria. Kidney Blood Press Res. 2012;35(6):483-8. doi: 10.1159/000337929. Epub 2012 Jun 8.

    PubMed 22687869

  • Imamura S, Hirai K, Hirai A. The glucagon-like peptide-1 receptor agonist, liraglutide, attenuates the progression of overt diabetic nephropathy in type 2 diabetic patients. Tohoku J Exp Med. 2013 Sep;231(1):57-61. doi: 10.1620/tjem.231.57.

    PubMed 24064677

  • Ahmad SR, Swann J. Exenatide and rare adverse events. N Engl J Med. 2008 May 1;358(18):1970-1; discussion 1971-2. No abstract available.

    PubMed 18456920

  • Bloomgren G, Braum D, Kolterman O. Exenatide and rare adverse events. N Engl J med 2008; 358: 1971-2.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exenatide and Lispro in people with Diabetic Nephropathies, run by Nanfang Hospital, Southern Medical University.

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 16 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

the percentage change of 24h-UAER(urinary albumin excretion rates) from baseline at Week 24 (time frame: from baseline at 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 NCT02690883, which also lists 17 linked publications.

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 9 Mar 2020.

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