Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy
NCT ID: NCT02690883
Last Updated: 2020-03-09
Study Results
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Basic Information
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COMPLETED
PHASE4
92 participants
INTERVENTIONAL
2016-04-08
2019-12-30
Brief Summary
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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).
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lispro
Patients 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.
Lispro
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.
Exenatide
Patients 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.
Exenatide
Exenatide (Astrazeneca ) 5 μg(initial dose)/10ug(maintenance dose) Subcutaneous injection Bid
Interventions
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Exenatide
Exenatide (Astrazeneca ) 5 μg(initial dose)/10ug(maintenance dose) Subcutaneous injection Bid
Lispro
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with type 2 diabetes with HbA1c ≥ 7.0% and ≤ 11.0% at screening (the result is valid for seven days).
3. Men and women (non-pregnant and using a medically approved birth-control method) aged from 18 to 80 at screening.
4. Body mass index (BMI) ≥18 and ≤35 kg/m2.
5. 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).
Exclusion Criteria
2\. Diagnosis or history of:
1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
2. 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.
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.
18 Years
80 Years
ALL
Yes
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Yaoming Xue
Department of Endocrinology and Metabolism
Principal Investigators
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Xue, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Endocrinology & Metabolism, Nanfang Hospital
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Bloomgren G, Braum D, Kolterman O. Exenatide and rare adverse events. N Engl J med 2008; 358: 1971-2.
Yanagisawa K, Ashihara J, Obara S, Wada N, Takeuchi M, Nishino Y, Maeda S, Ishibashi Y, Yamagishi S. Switching to multiple daily injection therapy with glulisine improves glycaemic control, vascular damage and treatment satisfaction in basal insulin glargine-injected diabetic patients. Diabetes Metab Res Rev. 2014 Nov;30(8):693-700. doi: 10.1002/dmrr.2537.
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Other Identifiers
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ESR-14-10425
Identifier Type: -
Identifier Source: org_study_id
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