FLOW

Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease

CURRENTLY RECRUITING

Chronic kidney disease (CKD) and diabetes often co-exist and generally the kidney damage is caused directly by poorly controlled diabetes. Whilst improved glucose and blood pressure control are key recommendations in treatment guidelines for CKD in type 2 diabetes (T2D), there remains a major unmet medical need to improve the treatment of CKD in patients with T2D. Recently conducted clinical trials with the glucagon-like peptide-1 (GLP-1) receptor agonists have suggested a possible renoprotective effect in patients with T2D, CKD and high cardiovascular (CV) risk.

In previous clinical trials the GLP-1 semaglutide has provided superior long-term glycaemic control in T2D patients and clinically relevant reductions in body weight as compared to other commonly used marketed glucose lowering products and to placebo.

The FLOW study will examine the effect of semaglutide, when added to standard-of-care, to see if it lowers the risk of renal and cardiovascular mortality compared to placebo, in study participants with type 2 diabetes and chronic kidney disease. Participants will use a 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. It is anticipated that this will be in about 3 to 5 years.

Suitable participants for this study need to have:

  1. Been diagnosed with type 2 diabetes
  2. HbA1c ≤ to 10%
  3. Renal impairment
  4. Treatment with maximum tolerated dose of either an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB)

For further information contact med.flow@monash.edu or call the study centre on 1800 199 108.

Funding

Novo Nordisk A/S.

Trial Registration

NCT03819153