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Introduction To investigate the safety of insulin lispro Mix 25 and 50 (LM25 and LM50) in hypoglycemia in patients with type 2 diabetes mellitus (T2DM). Methods This was a post hoc analysis of a phase IV, randomized, crossover clinical trial in Chinese patients with T2DM switching from premixed human insulin 70/30 (PHI70/30) to LM25 or LM50. Eighty-one subjects received a two-stage crossover protocol of either LM25 or LM50 twice daily for 16 weeks. Habitual diet was taken, and self-monitoring of blood glucose (SMBG) was performed throughout the study period. High-carbohydrate diet (HCD), high-fat diet (HFD) and habitual diet patterns were taken, and 72 h continuous glucose monitoring (CGM) was performed at the last 3 days of each treatment stage. Results The frequencies of nocturnal hypoglycemia in LM50 were lower than those in LM25 under a Chinese habitual diet pattern. The related factors of hypoglycemia in patients with T2DM treated with a LM25 or LM50 regimen were the weight-based daily mean insulin dose and the type of combined oral hypoglycemic agents. Under both HCD and habitual diet patterns, the optimal cut point values of bedtime glucose predicting nocturnal hypoglycemia in LM50 were lower than those in LM25. Conclusions The risk of nocturnal hypoglycemia in the LM50 regimen was lower than that in the LM25 regimen under the HCD pattern, and the safety range of bedtime glucose for the LM50 regimen was wider than that of the LM25 regimen in Chinese T2DM patients. Premixed insulin analogs combined with acarbose were more helpful to reduce the incidence of hypoglycemia. Trial Registration http://www.chictr.org.cn #ChiCTR-TTRCC-12002516.

Introduction To investigate the relative contribution rates of basal hyperglycemia (BHG) and postprandial hyperglycemia (PPHG) to overall hyperglycemia in patients with type 2 diabetes mellitus (T2DM) treated with insulin lispro mix 25 and 50 (LM25 and LM50) as evaluated by continuous glucose monitoring (CGM). Methods Eighty-one T2DM patients treated with premixed human insulin 70/30 (PHI70/30) were randomly divided into two groups and received a crossover protocol. In the first 16-week stage, one group received LM25 twice daily, the other group received LM50 twice daily. In the second 16-week stage, the two groups exchanged therapeutic regimen. Glycosylated hemoglobin (HbA1c) measurement and CGM were performed at enrollment and at the end of each treatment stage. Results BHG’s contribution rate increased with increasing HbA1c (from 34.5% to 60.8%). PPHG’s contribution rates in the LM50 regimen were significantly lower than those in LM25 and PHI70/30 regimens at HbA1c levels

Introduction We 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). Methods In 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. Results The 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. Conclusions LM50 may provide better glycemic excursion control after breakfast and dinner than LM25 in T2DM patients. Trial Registration http://www.chictr.org.cn # ChiCTR-TTRCC-12002516. Funding Lilly Suzhou Pharmaceutical Co., Ltd. (Shanghai Branch, China) and National Key Program of Clinical Science of China (WBYZ 2011-873).

Introduction The aim of the study was to investigate the clinical safety and effectiveness of starting insulin aspart (aspart) therapy in people with type 2 diabetes mellitus (T2DM) as a sub-analysis of the multinational, non-interventional A1chieve study. Methods Insulin-naïve and insulin-experienced people with T2DM in routine clinical care starting aspart alone at baseline and continuing aspart alone, changing to biphasic insulin aspart 30 (aspart premix) or adding a basal insulin by study end, were included. Safety, tolerability, and efficacy were evaluated over 24 weeks. Results Overall, 3,898 people started aspart at baseline. Of the 3,313 with 24-week data, 1,545 (46.6%) continued with aspart, 1,379 (41.6%) switched to aspart premix, and 214 (6.5%) added basal insulin, while the remainder switched to other regimens. No serious adverse drug reactions were reported. The proportion of participants reporting hypoglycemia decreased from baseline to week 24 in the aspart alone group (11.2% versus 4.1%, p