What the trial was testing
The ONWARDS 6 enrolled 582 patients with type 1 diabetes. The study was sponsored by Novo Nordisk A/S and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The weekly insulin caused 1.9 times more low blood sugar events than the daily insulin.
Lancet (London, England) · 2023 · NCT04848480
These findings — that the weekly insulin caused nearly twice as many dangerous low blood sugar episodes compared to daily insulin — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 582 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with type 1 diabetes, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a large-scale study, but the weekly insulin is not yet FDA-approved. The higher rate of low blood sugar episodes is a concern that doctors will need to consider. If you have type 1 diabetes, talk with your doctor about whether once-weekly insulin options might become available and whether they'd be right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open type 1 diabetes trials
The Effect of Glycemic Control and of GLP-1 Receptor Agonism on Islet GLP-1 in People With Type 1 and Type 2 Diabetes
The investigators recently demonstrated that blockade of Glucagon-Like Peptide-1's (GLP-1) receptor (GLP1R) results in changes in islet function without changes in circulating GLP-1. These effects are more pronounced in people with early type 2 diabetes (T2DM) in keeping with increased expression of PC-1/3 and GLP-1 that is observed in diabetic islets. However, its regulation is at present unknown. There is evidence that α-cell proglucagon processing is subject to paracrine regulation by the β-cell3. It is unclear if the effects of GLP1R agonism on islet GLP-1 differ in Type 1 diabetes (T1DM) compared to T2DM. This experiment will examine the effect of glycemic control ± a GLP1R agonist on islet GLP-1 in people with (T2DM) and without (T1DM) β-cells.
Type 1 Diabetes and Obstructive Sleep Apnea
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.