Why carry out the study?

Several benefits of switching from basal-bolus insulin treatment (BBIT) to a fixed combination of insulin degludec and liraglutide (IDegLira) have been documented in trials in patients with type 2 diabetes mellitus (T2DM), but these studies were either small, monocentric, of short duration, included only patients with relatively good glycemic control, had a retrospective design using data from medical databases, and/or lacked data on the incidence of hypoglycemia; none utilized continuous glucose monitoring (CGM).

The primary aim of our study, called "Simplify," was to evaluate whether switching from BBIT to IDegLira in patients with T2DM with preserved insulin secretion but inadequate glucose control is at least as effective and safe as the preceding BBIT. A secondary aim was to determine whether such a therapeutic approach can be implemented in routine clinical practice.

What was learned from this study?

Switching from BBIT to IDegLira in patients with T2DM with preserved insulin secretion led to significant improvements in all glucose control parameters (HbA1c, glycemic profile, decrease in hypoglycemia events, decrease in insulin doses) and significant reductions in body weight, blood pressure, lipid profile, and liver enzymes. Patient satisfaction with the treatment also improved. The subgroup of patients who underwent CGM also showed a significant increase in time in range and a decrease in time above range), while time below range, hypoglycemia (number of episodes per patient and proportion of patients), and glucose variability did not change significantly.

Switching from BBIT to a fixed combination of IDegLira in patients with T2DM with preserved insulin secretion could be a beneficial and safe approach in clinical practice, offering complex metabolic and individual benefits.