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

March 5, 2020 updated by: Yaoming Xue, Nanfang Hospital of Southern Medical University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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 Names:
  • Humalog
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.
Drug: Exenatide
Exenatide (Astrazeneca ) 5 μg(initial dose)/10ug(maintenance dose) Subcutaneous injection Bid
Other Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage change of 24h-UAER(urinary albumin excretion rates) from baseline at Week 24
Time Frame: from baseline at Week 24
the percentage change of 24h-UAER=(24h-UAERweek24 - 24h-UAERbaseline)/ 24h-UAERbaseline
from baseline at Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage change of ACR
Time Frame: from baseline at Week 24
the percentage change of ACR=(ACRweek24 - ACRbaseline)/ ACRbaseline
from baseline at Week 24
Change in 24h-UAER
Time Frame: from baseline at Week 24
Change in 24h-UAER =24h-UAERweek24 - 24h-UAERbaseline
from baseline at Week 24
Change in HbA1c
Time Frame: from baseline at Week 24
Change in HbA1c=HbA1cweek24-HbA1cbaseline
from baseline at Week 24
Change in FPG
Time Frame: from baseline at Week 24
Change in FPG=FPGweek24-FPGbaseline
from baseline at Week 24
Change in Weight
Time Frame: from baseline at Week 24
Change in weight=Weightweek24-Weightbaseline
from baseline at Week 24
Change in Blood pressure
Time Frame: from baseline at Week 24
Change in blood pressure=SBPweek24-SBPbaseline
from baseline at Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Xue, PhD, Department of Endocrinology & Metabolism, Nanfang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2016

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

February 20, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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