Effects of Insulin Lispro Mix 25 and Insulin Lispro Mix 50 on Postprandial Glucose Excursion in Patients with Type 2 Diabetes: A Prospective, Open-Label, Randomized Clinical Trial

Abstract

IntroductionWe compared the effects of insulin lispro mix 25 (LM25) and insulin lispro mix 50 (LM50) on postprandial glucose excursion in patients with type 2 diabetes mellitus (T2DM).MethodsIn this randomized, open-label, investigator-initiated trial, 81 T2DM patients treated with premixed human insulin 70/30 (PHI70/30) for more than 90 days were randomly divided into two groups and received a crossover protocol of either LM25 or LM50 twice daily for 16 weeks. Continuous glucose monitoring (CGM) was performed for 72 h at baseline and at the end of each treatment phase to evaluate glycemic excursions in the subjects.ResultsThe LM50 regimen resulted in significantly smaller postprandial glycemic excursions than the LM25 regimen after breakfast (1.3 ± 2.5 vs. 2.4 ± 2.6 mmol/L, P = 0.046) and dinner (1.5 ± 2.8 vs. 2.8 ± 2.4 mmol/L, P = 0.036). Glycosylated hemoglobin levels were similar for the patients on the three regimens. The percentage of patients who achieved their glycosylated hemoglobin target was significantly higher for the LM25 and LM50 regimens than for the PHI70/30 regimen, regardless of whether the target was set at 7.0% or 6.5%. The proportion of the patients who were hypoglycemic for a high percentage (> 10%) of the time was lower for the LM50 regimen than for the LM25 and PHI70/30 regimens.ConclusionsLM50 may provide better glycemic excursion control after breakfast and dinner than LM25 in T2DM patients.Trial Registrationhttp://www.chictr.org.cn # ChiCTR-TTRCC-12002516.FundingLilly Suzhou Pharmaceutical Co., Ltd. (Shanghai Branch, China) and National Key Program of Clinical Science of China (WBYZ 2011-873).

The Effect of LM25 and LM50 on Hypoglycemia in Chinese T2DM Patients: Post Hoc Analysis of a Randomized Crossover Trial

“…For example, LM25 (Humalog Ò Mix25, which contains 25% insulin lispro and 75% insulin lispro protamine) and LM50 (Humalog Ò Mix50, which contains 50% insulin lispro and 50% insulin lispro protamine) are widely used as the starting insulin. The CLAS-SIFY study and our previous study have confirmed that although the effects of the two types of insulin on glycosylated hemoglobin (HbA 1c ) are similar, LM50 provides better postprandial glycemic control than LM25 [9,10].…”

“…A subgroup analysis of the Chinese population in the CLASSIFY study showed that fewer patients reported nocturnal hypoglycemic episodes in the LM50 than LM25 treatment group; however, more nocturnal hypoglycemic episodes were reported in the LM50 than LM25 treatment group, both without significant differences [16]. Our study used the data on the percentage of hypoglycemic time recorded by continuous glucose monitoring (CGM)and found that a smaller proportion of the patients on the LM50 regimen spent a high percentage ([ 10%) of their hypoglycemic time compared with those on the LM25 (p \ 0.05) [10]. This may be related to the fact that CGM is more likely to detect hypoglycemia that is not noticeable at night.…”

“…The data of the post hoc analysis were from our study on a phase IV, randomized, crossover, open-label, investigator-initiated clinical trial in Chinese patients with T2DM switching from premixed human insulin 70/30 (PHI70/30) to LM25 or LM50. This clinical trial was registered at http://www.chictr.org.cn (ChiCTR-TTRCC-12002516) [10].…”

“…The subjects got a 4-point BG profile by SMBG (preprandial BG of three meals plus bedtime BG at least 1 day every week, adding a BG test while having hypoglycemia symptoms and recording severe hypoglycemia episodes that required others' help). They were followed up every 2 weeks to adjust the insulin dose according to the BG profile (insulin sliding scale was presented in a previous article [10]). The targets of insulin titration were BG [ 3.9 mmol/l and B 6.1 mmol/l before breakfast and dinner.…”

“…A total of 86 subjects were recruited into the trial, with 81 completing the study. The patient disposition was presented in a previous article [10]. The demographics and baseline characteristics of the subjects are shown in Table 1.…”