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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
Lead sponsor
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 18-35•HbA1c 7-11%•eGFR ≥30•UACR ≥0.3
Primary endpoint
•24h-UAER
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointChange in Weight
Time frame:from baseline at Week 24
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange in HbA1c
Time frame:from baseline at Week 24
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in FPG
Time frame:from baseline at Week 24
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Renal / kidney
3 endpointsthe 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
the percentage change of ACR
Time frame:from baseline at Week 24
uACR, % change
percent change from baseline, improvement
LOINC 9318-7
Change in 24h-UAER
Time frame:from baseline at Week 24
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange 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
- The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
- Diabetes/metabolism research and reviews2014 Nov (month)PMID24639403doi:10.1002/dmrr.2537via CT.gov background
- Cellular physiology and biochemistry : international journal of experimental cellular physiology, biochemistry, and pharmacology2014 (year)PMID24556697doi:10.1159/000358623via CT.gov background
- International journal of nephrology and renovascular disease2014 (year)PMID25342915doi:10.2147/IJNRD.S40172via CT.gov background
- The Tohoku journal of experimental medicine2013 Sep (month)PMID24064677doi:10.1620/tjem.231.57via CT.gov background
- Current pharmaceutical design2013 (year)PMID23176216doi:10.2174/1381612811319170009via CT.gov background
- The New England journal of medicine2008 May 1PMID18456920via CT.gov background
- Journal of diabetes and its complications2008 Mar-Apr (year)PMID18280439doi:10.1016/j.jdiacomp.2007.08.001via CT.gov background
- Journal of the American Society of Nephrology : JASN2007 Apr (month)PMID17360951doi:10.1681/ASN.2006070778via CT.gov background
- American journal of kidney diseases : the official journal of the National Kidney Foundation2007 Feb (month)PMID17276798doi:10.1053/j.ajkd.2006.12.005via CT.gov background
- Journal of the American Society of Nephrology : JASN2006 Aug (month)PMID16825327doi:10.1681/ASN.2006050517via CT.gov background
- The New England journal of medicine1993 Sep 30PMID8366922doi:10.1056/NEJM199309303291401via CT.gov background
Provenance
Sources
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.