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Efficacy of Liraglutide as add-on to glucose-lowering therapy in Patients with biopsy proven Type 2 diabetic nephropathy: a multi-center, randomised, open-label trial

Efficacy of Liraglutide as add-on to glucose-lowering therapy in Patients with biopsy proven Type 2 diabetic nephropathy: a multi-center, randomised, open-label trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036503
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Interventions

experimental group:Liraglutide+Standard treatment
control group:Standard treatment

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged >=18 years; 2) Type 2 diabetes diagnosed by an endocrinologist; 3) Patients from the Department of Nephrology, Shanghai Sixth People's Hospital, pathologically diagnosed as diabetic nephropathy from January 2010 to December 2020; 4) eGFR (calculated by CKD-EPI formula)> 30 ml/min/1.73m2; 5) HbA1c 6% to 9% within three months; 6) No treatment of SGLT2i in the past 10 weeks; 7) The stable dose of ACEI or ARB has lasted at least 4 weeks; 8) Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1) Systolic blood pressure >=180mmHg or diastolic blood pressure >=110mmHg; 2) GLP-1RA or DPP-4i use 3 months before enrollment, received insulin other than human neutral protamine (NPH) insulin or long-acting insulin analogues; 3) HbA1c >9% or HbA1c 13.9mmol/l (>250mg/dl); 4) Renal pathology confirmed DN combined with IgA nephropathy, membranous nephropathy, lupus nephritis and other pathological types; 5) Diabetic ketoacidosis occurred in the past year; 6) Maintenance dialysis or kidney transplantation; 7) Liver function insufficiency, and aspartate aminotransferase or alanine aminotransferase exceeds the upper limit of normal by more than 3 times or total bilirubin exceeds the upper limit of normal by more than 2 times; 8) Combined with other systemic diseases, and are receiving hormone or immunosuppressive therapy; 9) Patients with past or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine tumor syndrome type 2 (MEN2); 10) Patients with severe cardiovascular disease in 8 weeks: myocardial infarction, coronary artery bypass graft or ischemic heart disease caused by PCI surgery, congestive heart failure (heart function grade III-IV, NYHA rating) 11) Patients who have had severe cerebrovascular disease within 8 weeks: stroke, significant neurological dysfunction left after stroke; 12) Patients with active gastrointestinal bleeding within three months; 13) Pregnant or lactating women and women who plan to become pregnant or have no contraceptive plan; 14) Patients with malignant tumors, or the expected survival period is less than 6 months; 15) Intolerance or allergy to liraglutide; 16) According to the judgment of the researcher, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as mental illness, frequent changes in the living and working environment, etc. that may easily cause loss to follow-up.

Design outcomes

Primary

MeasureTime frame
urinary albumin creatinine ratio;

Secondary

MeasureTime frame
Change of EGFR slope from baseline;

Countries

China

Contacts

Public ContactFan Ying

Shanghai Sixth People's Hospital

fanyingsh@126.com+86 18930173178

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026