[Starting an insulin regimen with insulin lispro mix 25 versus glargine insulin for type 2 diabetes]. / Régimen con insulina lispro mix 25 versus insulina glargina para la diabetes tipo 2.

ABSTRACT

Information on starting insulin regimens in specific populations with type 2 diabetes (T2D) is limited. This analysis compared efficacy and safety of two starter insulin regimens insulin lispro mix 25 (LM25) and basal insulin glargine (GL) in patients from Argentina. This post-hoc analysis evaluated 193 insulin-naïve patients who participated in the DURABLE trial 24-week initiation phase. Patients 30-79 years with T2D inadequately controlled (HbA1c > 7.0%) with = 2 oral antihyperglycemic medications (OAMs), were randomized to add LM25 (25% insulin lispro, 75% insulin lispro protamine suspension) twice daily or GL (basal insulin glargine) once daily to pre-study OAMs. Primary efficacy was measured by HbA1c at 24-week endpoint. Secondary measures included proportion of patients achieving HbA1c = 6.5% and = 7.0%, body weight change, self-monitored blood glucose (BG) values, and hypoglycemia rates. LM25 demonstrated greater HbA1c reduction (- 2.4% ± 0.16 vs. -2.0% ± 0.16, P = 0.002), a higher proportion of patients achieving HbA1c = 7.0% (P = 0.012), and lower BG levels after the morning (P = 0.028) and evening (P = 0.011) meals, and at 300AM (P = 0.005) compared with GL. Fasting BG and proportion of patients achieving HbA1c = 6.5% were similar between groups. Both groups increased body weight, although the gain was higher at endpoint with LM25 (6.35 kg vs. 4.23 kg, P < 0.001). No differences in hypoglycemia rates were observed between groups, and no serious adverse events were reported for either group. In this subgroup from Argentina, LM25 demonstrated greater improvement in glucose control with similar risk of hypoglycemia and more weight gain than GL.