A research study to find out how semaglutide works in the kidneys compared to placebo, in people with type 2 diabetes and chronic kidney disease

Phase 1

• Conditions: Diabetes Mellitus, Type 2Chronic kidney disease; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-000828-19-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2D =180 days prior to the day of screening.
- HbA1c =9.0% (=75 mmol/mol).
- Serum creatinine-based eGFR =40 and =75 mL/min/1.73 m2 (CKD-EPI).
- UACR =30 and <5000 mg/g.
- Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system
(RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB). Treatment dose must be stable for at least 28 days prior to screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

- Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA) within 30 days prior to screening.
- A prior solid organ transplant or awaiting solid organ transplant.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Presence or history of malignant neoplasms (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening.
- Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and V2. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Treatment with systemic anti-inflammatory or immunosuppressant drugs within 90 days prior to screening. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed.
• Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared magnetic resonance (MR) compatible.
• Combination use of an ACE inhibitor and an ARB.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified