ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02690883
Recruitment Status : Unknown
Verified February 2016 by Yaoming Xue, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Yaoming Xue, Nanfang Hospital of Southern Medical University

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: Exenatide Drug: Lispro Phase 4

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy: a 24- Week Study
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Byetta




Primary Outcome Measures :
  1. the percentage change of 24h-UAER(urinary albumin excretion rates) from baseline at Week 24 [ Time Frame: from baseline at Week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures.
  2. Diagnosed with type 2 diabetes with HbA1c ≥ 7.0% and ≤ 10.0% 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 70 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.GFR >45ml/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 one year.

    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 <45ml/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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690883


Contacts
Contact: Zhang, PhD 020-61641637 chenyuezhang@163.com
Contact: Xu, PhD 020-61641637 xuww1988@126.com

Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Principal Investigator: Xue, PhD Department of Endocrinology & Metabolism, Nanfang Hospital

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

Responsible Party: Yaoming Xue, Department of Endocrinology and Metabolism, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02690883     History of Changes
Other Study ID Numbers: ESR-14-10425
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Exenatide
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists