A recent study in Lancet Diabetes & Endocrinology revealed the superiority of IcoSema, given once weekly, compared to daily basal-bolus therapy (BBT) in the treatment of type 2 diabetes in adults. 
The study compared the safety and efficacy of IcoSema and basal-bolus therapy (BBT) in type 2 diabetes patients who were already on daily basal insulin therapy.
Researchers conducted a 52-week, randomized, Phase 3A trial in 14 countries, across 109 outpatient clinics and hospital departments. The study included 844 T2D patients (HbA1c 7.0-10.0% [53.0-85.8 mmol/mol]) aged 18 years or older who were receiving daily basal insulin (20-80 U per day). The participants were randomized to receive BBT (339) (once-daily insulin glargine U100 with two to four daily insulin aspart injections) using an automated, interactive central web-response system or once-weekly IcoSema injection (n=340) using a pen device.
The change in HbA1c from baseline to week 52 was considered the primary endpoint. The secondary endpoints included severe hypoglycemic episodes from baseline to week 57, combined clinically significant hypoglycemic episodes (<3.0 mmol/L [<54 mg/dL], confirmed by blood glucose meter), weekly total insulin dose during weeks 50-52, and change in body weight from baseline to week 52. The endpoints were evaluated using the data of all randomly assigned participants in the treatment group. Further, the data from the participants exposed to the intervention were used to perform Descriptive statistics for safety endpoints.
Results confirmed the non-inferiority of IcoSema compared to BBT, as indicated by the change in HbA1c. With IcoSema, the mean change in HbA1c was -1.47 percentage points at week 52, and -1.40 percentage points with BBT. Overall rate of clinically significant or severe hypoglycemia from baseline to week 57 (0.21 vs 2.23 episodes per person-year of exposure; estimated rate ratio 0.12 [0.08 to 0.17]), weekly total insulin dose during weeks 50-52 (ETD -270 U [-303 to -236]), and change in body weight from baseline to week 52 (ETD -6.72 kg [95% CI -7.58 to -5.86]) demonstrated the superiority of IcoSema than BBT.
However, participants in the IcoSema group reported gastrointestinal events (443 events). One-hundred-sixteen participants from BBT reported infections and infestations (193 events).