This content originally appeared on diaTribe. Republished with permission.
By Divya Gopisetty
A trial is enrolling over 3,000 individuals living with type 2 diabetes and chronic kidney disease
Clinical Trial Identifier: NCT03819153
Trial Name: A Research Study to See How Semaglutide Works Compared to Placebo in People with Type 2 Diabetes and Chronic Kidney Disease (FLOW)
Diabetes type: Type 2
What the trial is testing:
Ozempic (semaglutide) is a once-weekly injectable GLP-1 agonist already approved for use in people with type 2 diabetes. This trial will test whether Ozempic can slow down the progression of chronic kidney disease (CKD) in people with type 2 diabetes. Trial participants will be randomized to take either Ozempic or a placebo (a “nothing” injection).
What the trial is measuring:
The study is primarily measuring kidney function, determined by change in eGFR (estimated glomerular filtration rate – a measure of kidney health and progression to chronic kidney disease). Researchers will also record occurrences of heart-related hospitalizations, changes to body weight, A1C, and blood pressure.
Why is this new/important?
About 40% of people with type 2 diabetes live with chronic kidney disease. Earlier this year, results from the CREDENCE trial showed that people taking Invokana, an SGLT-2 inhibitor, had 30% lower risk of end stage kidney disease, worsening kidney function, and kidney-related death. There remains a need for more options to prevent the progression of kidney-related complications in people with diabetes.
Trial length: 3-5 years (but could be longer)
Trial locations: This large trial is enrolling over 3,000 participants in 342 locations, including multiple U.S. states and international locations.
Are you interested? Eligibility criteria include:
- 18 years and older
- Type 2 diabetes diagnosis
- Renal impairment as measured by eGFR greater than 50 and less than or equal to 75 (eGFR is reported in mL/min/1.73m2)
- A1C less than or equal to 10%
- Cannot use a GLP-1 agonist (Byetta/Bydureon, Victoza, Lyxumia/Adlyxin, Trulicity, Ozempic) within 30 days of screening
See a full list of eligibility criteria here.
Where to get more information: Contact Novo Nordisk at 886-867-7178 or email them at firstname.lastname@example.org.
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Read more about A1c, clinical trial, GLP-1, Intensive management, Novo Nordisk, Ozempic (semaglutide), SGLT-2.