Pragmatic trial challenges ‘dogma’ of basal–bolus insulin for advanced type 2 diabetes
medwireNews: Combining a glucagon-like peptide (GLP)-1 receptor agonist or sodium-glucose cotransporter (SGLT)2 inhibitor with basal insulin allows people with type 2 diabetes on a basal–bolus regimen to drop the prandial insulin, shows the pragmatic BEYOND trial.
Glycemic control was similar with all three treatment approaches, but people who switched to the combination treatments experienced less hypoglycemia, and reduced or maintained rather than increased their bodyweight, report the investigators.
Furthermore, because the two alternative regimens used were a fixed-ratio insulin and GLP-1 receptor agonist combination and basal insulin plus an SGLT2 inhibitor, people randomly assigned to these treatments were able to reduce their daily injections from four to just one.
The BEYOND findings challenge “the dogma about the untouchability” of the basal–bolus regimen for advanced type 2 diabetes, say Dario Giugliano and co-researchers from University of Campania “Luigi Vanvitelli” in Naples, Italy.
They add: “To our knowledge, our study is the first trial to assess the role of simplification of complex insulin regimen in patients with type 2 diabetes in their current clinical practice, beyond any structured support system associated with classical randomized controlled trials.”
They note that the pragmatic study design did not allow for an intensive treat-to-target approach, with medications instead titrated according to current guidelines. Study participants were seen only at the 3- and 6-month follow-up points, although they received weekly telephone calls in between.
All trial participants had type 2 diabetes with a glycated hemoglobin (HbA1c) level greater than 7.5% (58 mmol/mol) despite being on a full basal–bolus insulin regimen.
During 6 months of follow-up, symptomatic hypoglycemia occurred at least once in 7.8% and 5.9% of participants randomly assigned to take the GLP-1 receptor agonist and SGLT2 inhibitor combinations, respectively, compared with 17.8% in those who intensified their pre-existing basal–bolus regimen.
Participants using the GLP-1 receptor agonist combination had a significant average 1.9 kg reduction in bodyweight and the SGLT2 inhibitor combination group had a nonsignificant 0.6 kg reduction, whereas the basal–bolus insulin group gained a nonsignificant average of 0.3 kg.
All three treatment regimens used in the trial produced similar outcomes for the primary endpoint of change in HbA1c.
Specifically, the 102 people using the GLP-1 receptor agonist combination achieved an average 0.6% reduction in HbA1c levels, while the 102 taking the SGLT2 inhibitor combination achieved a 0.7% reduction. These changes were not significantly different to the average 0.6% HbA1c reduction seen for the 101 people on basal–bolus insulin.
Also, a corresponding 28%, 27%, and 34% achieved HbA1c levels of 7.5% or lower, report the researchers in Diabetes Care.
They stress: “Although this may be considered not optimal in term of target achievement, nonetheless, it represents the result of a simple therapeutic algorithm to be used in clinical practice both in outpatient or inpatient departments, beyond the complexity of somewhat discouraging titration protocols.”
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