Comparative efficacy and safety of two fixed ratio combinations in type 2 diabetes mellitus patients previously poorly controlled on different insulin regimens: a multi-centric observational study.

Abstract

To evaluate the efficacy and safety profile of fixed ratio combinations (FRC) in patients with type 2 diabetes mellitus (DMT2) poorly controlled on different insulin regimens. This multicentric observational study included 376 patients (157 males, 219 female), with longstanding DMT2 inadequately controlled (HbA1c >7%) on different insulin regimens; premix insulin analogs (MIX) (23.2%), basal-bolus regimen (BB) (30.9%) or basal oral therapy (BOT) (37.1%) to whom FRC was introduced at least 6 months prior to data collection. Median age of patients was 67 years, with the duration of diabetes for 14 years, median HbA1c of 8.4% and BMI of 34.35 kg/m2. The proportion of patients treated with IDegLira and IGlarLixi was similar (48.4% vs. 51.6%). There was a borderline difference regarding regimen groups (p = 0.059) implying the greatest improvement of HbA1c in the MIX group. The significant interaction between BOT and BB/MIX regimens (p = 0.011) was noted indicating the largest reduction of BMI in BB and MIX groups. After the FRC administration, there was no significant difference in gastrointestinal (GIT) side-effects. The number of patients with hypoglycemic episodes decreased from 24% to 7% after FRC initiation (p < .001). The group using IGlarLixi required a significantly higher average dose steps compared to IDegLira (p < .001 for all) to achieve glycemic goals, while a larger proportion of patients using IDegLira lost more than 5 kg, compared to IGlarLixi (p < .001). Significant improvement was observed in all glycemic parameters in all insulin treated patients after replacement of insulin therapy with FRC (p < .001 for all). Composite outcome defined as any weight loss and HbA1c below 7% was accomplished in 20.3% of patients. In real life setting switching to both FRC options in people with longstanding inadequately controlled DMT2 treated with different insulin regimens could offer an effective therapeutic choice for achieving glycemic goals, with an improved safety profile.