Phase 3
N=3,533
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03819153 ↗Enrolled (actual)
3,533
Serious AEs
51.7%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death — 331; 410 Participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide (Drug); Placebo (semaglutide) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death |
331; 410 | 0.0001 sig |
| SECONDARY Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope) |
-2.19; -3.36 | — |
| SECONDARY Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI) |
165; 213 | — |
| SECONDARY Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2 |
92; 110 | — |
| SECONDARY Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy |
87; 100 | — |
| SECONDARY Number of Participants From Time of Randomization to Occurrence of Renal Death |
5; 5 | — |
| SECONDARY Number of Participants From Time of Randomization to Occurrence of CV Death |
123; 169 | — |
| SECONDARY Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope) |
-2.36; -3.30 | — |
| SECONDARY Change From Baseline in eGFR (CKD-EPI) at Week 12 |
-1.07; -1.07 | — |
| SECONDARY Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104 |
-2.1; -5.4 | — |
| SECONDARY Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline |
0.60; 0.89 | — |
| SECONDARY Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death |
212; 254 | — |
| SECONDARY Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death |
227; 279 | — |
| SECONDARY Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction |
52; 64 | — |
| SECONDARY Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke |
63; 51 | — |
| SECONDARY Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization |
16; 28 | — |
| SECONDARY Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization |
1; 3; 16; 25 | — |
| SECONDARY Change From Baseline in Body Weight at Week 104 |
-5.54; -1.43 | — |
| SECONDARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104 |
-0.86; -0.04 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 104 |
-3.9; -1.4 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 104 |
-0.4; -0.8 | — |
| SECONDARY Number of Severe Hypoglycaemic Episodes |
37; 37 | — |
Summary
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.
Eligibility Criteria
Inclusion Criteria
- Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus
- HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
- Renal impairment defined either by:
- serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
- serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 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 an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening
Exclusion Criteria
- Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
- Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
- Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- Planned coronary, carotid or peripheral artery revascularisation
- Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
- 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 randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Data sourced from ClinicalTrials.gov (NCT03819153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.