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Trial · Interventional

CompletedPhase 4Registry data

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

Overview

Status
Completed
Phase
Phase 4
Enrollment
92 participants (actual)
Sponsor
Nanfang Hospital, Southern Medical University · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
8 Apr 2016
Primary completion
13 Dec 2019
Completion
30 Dec 2019
First posted
24 Feb 2016 (estimated)
Last update posted
9 Mar 2020
Conditions
Diabetic Nephropathies

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 4

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

    NCT02690883

    8 Apr 2016 to 30 Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • ExenatideDrug
  • LisproDrug

Arms2

  • Active comparator

    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.

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · from baseline at Week 24

    Registry description

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

Secondary outcomes(6)
  1. the percentage change of ACR

    Time frame · from baseline at Week 24

    Registry description

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

  2. Change in 24h-UAER

    Time frame · from baseline at Week 24

    Registry description

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

  3. Change in HbA1c

    Time frame · from baseline at Week 24

    Registry description

    Change in HbA1c=HbA1cweek24-HbA1cbaseline

  4. Change in FPG

    Time frame · from baseline at Week 24

    Registry description

    Change in FPG=FPGweek24-FPGbaseline

  5. Change in Weight

    Time frame · from baseline at Week 24

    Registry description

    Change in weight=Weightweek24-Weightbaseline

  6. Change in Blood pressure

    Time frame · from baseline at Week 24

    Registry description

    Change in blood pressure=SBPweek24-SBPbaseline

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results

Indexing hint: Animal study · 2014

1 result

Exendin-4 alleviates high glucose-induced rat mesangial cell dysfunction through the AMPK pathway.

Xu et al. 2014Cellular physiology and biochemistry : international journal of experimental cellular physiology, biochemistry, and pharmacologycited by 35

PMID 24556697DOI 10.1159/000358623PUB-24556697

Full text at the publisher1 result

Indexing hint: Clinical trial · 2013

5 results

The glucagon-like peptide-1 receptor agonist, liraglutide, attenuates the progression of overt diabetic nephropathy in type 2 diabetic patients.

Imamura et al. 2013The Tohoku journal of experimental medicinecited by 51

PMID 24064677DOI 10.1620/tjem.231.57PUB-24064677

Full text at the publisher5 results

Indexing hint: Randomized controlled trial · 2012

4 results

Exenatide reduces urinary transforming growth factor-β1 and type IV collagen excretion in patients with type 2 diabetes and microalbuminuria.

Zhang et al. 2012Kidney & blood pressure researchcited by 69

PMID 22687869DOI 10.1159/000337929PUB-22687869

Full text at the publisher4 results

Indexing hint: Animal study · 2007

17 results

Long-term treatment of glucagon-like peptide-1 analog exendin-4 ameliorates diabetic nephropathy through improving metabolic anomalies in db/db mice.

Park et al. 2007Journal of the American Society of Nephrology : JASNcited by 178

PMID 17360951DOI 10.1681/asn.2006070778PUB-17360951

Full text at the publisher17 results

More studies

1 study on this page

Indexing hint: Review · 2013

Effects of glucagon-like peptide-1 receptor agonists on renal function.

Filippatos et al. 2013World journal of diabetescited by 76

PMID 24147203PMC3797884DOI 10.4239/wjd.v4.i5.190PUB-24147203

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 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: 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: 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.

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