Biphasic insulin is a frequent intensification step when basal insulin alone provides inadequate glycemic control. Basal plus main-meal fast acting insulin may be equally effective and more acceptable: the LANSCAPE study tested whether “Basal Plus” insulin glargine (Lantus) once daily and insulin glulisine (Apidra) at main meal was non-inferior to twice daily “Biphasic” insulin aspart/aspart protamine 30/70 (NovoMix30) with respect to glycemic control (primary objective) and provided superior treatment satisfaction.
LANSCAPE was an international, controlled trial of adults with type 2 diabetes receiving basal insulin. Participants’ mean (SD) age was 61.6 (8.5) yrs, diabetes duration 12.9 (6.4) yrs and A1C 8.62 (0.94) %. During an 8-12 week run-in, oral agents except metformin were stopped and insulin glargine optimized. After run in, 335 participants with fasting glucose at <126mg/dl but suboptimal A1C (>7%) were randomized to a “Basal Plus” (n=170), or “Biphasic” (n=165) regimen. Active insulin titration followed standardized algorithms; 89% of patients (91.8% and 86.1% respectively) completed treatment.
At 24 weeks A1C fell by 1.00% in the Basal Plus and 1.22% in the Biphasic arms, mean difference 0.21% (SE 0.09, upper 97.5% CL 0.38), implying non-inferiority of Basal Plus relative to the Biphasic regimen (pre-defined margin 0.4%). There was no difference in overall hypoglycemia rates (15 vs. 18 events/patient-year respectively, p=0.2), but slightly more nocturnal events with Basal Plus (5.7 vs. 3.6 events/patient-year, p=0.02). Significant advantages favoring Basal Plus were shown in DTSQc and ITSQ treatment satisfaction measures.
In type 2 diabetes Basal Plus provides comparable glycemic control to a Biphasic regimen, better patient reported outcomes, and may present a more acceptable option for insulin initiation/intensification.