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CompletedPhase 4

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

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

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

Enrollment

92

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

BMI 18-35HbA1c 7-11%eGFR ≥30UACR ≥0.3

Primary endpoint

24h-UAER

Identifiers

Registered as

NCT IDNCT02690883
Org study IDESR-14-10425

Timeline

Milestones

Study first posted2016-02-24estimated
Study start2016-04-08actual
Primary completion2019-12-13actual
Study completion2019-12-30actual
Last update posted2020-03-09actual

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney
3
Glycemic / diabetes
2
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in Weight

Time frame:from baseline at Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in HbA1c

Time frame:from baseline at Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:from baseline at Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Renal / kidney

3 endpoints
Primary/protocol endpoint

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

Time frame:from baseline at Week 24

percent change from baseline, improvement

Secondary/protocol endpoint

the percentage change of ACR

Time frame:from baseline at Week 24

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change in 24h-UAER

Time frame:from baseline at Week 24

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change in Blood pressure

Time frame:from baseline at Week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Publications (16)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.