Insulinización en la diabetes mellitus tipo 2: Alternativas de intensificación / Insulinization in type 2 diabetes mellitus. Intensification options

La diabetes mellitus se asocia con complicaciones vasculares y elevadas tasas de morbimortalidad. La terapia oportuna con insulina y su intensificación cuando es necesaria, representan estrategias apropiadas para evitar o retardar la aparición de dichas complicaciones. Sin embargo, la incidencia de hipoglucemia y las dificultades en la adherencia al tratamiento representan barreras para alcanzar el éxito terapéutico. Las nuevas combinaciones de análogos de insulina constituyen tratamientos que presentarían ventajas farmacocinéticas y farmacodinámicas, logrando beneficios clínicos tales como un mejor control metabólico, la disminución de eventos hipoglucémicos y, por su simplicidad, potencialmente una mayor adherencia al tratamiento.

Diabetes mellitus is associated with vascular complications and high rates of morbidity and mortality. Timely insulin therapy, intensified when necessary, represent appropriate measures to prevent or delay the onset of complications. However, the incidence of hypoglycemia and difficulties in treatment adherence represent barriers to achieve therapeutic success. Premixes analogs and, specially, combinations of insulin analogues are associated with pharmacokinetic and pharmacodynamic advantages, that translate into clinical benefits such as improved metabolic control, decreased hypoglycemic events and, for their simplicity, potentially greater adherence.

Comparison of efficacy and safety between biphasic insulin aspart 50 and biphasic human insulin 50：A randomized crossover trial / 中华内分泌代谢杂志

Objective To investigate the efficacy of biphasic insulin aspart 50(BIAsp50)twice daily(bid) versusbiphasichumaninsulin50(BHI50)(bid)plusmetforminonbloodglucosecontrolfollowingastandardmealtest in Chinese patients with type 2 diabetes mellitus(T2DM). Methods A randomized, open-label, 2-sequence, crossover trial for two 4-week treatment periods was conducted in 14 Chines institutes. Eligible subjects inadequately controlled with BHI50(bid)plus metformin were randomized to two sequences in a 1 : 1 ratio(A:BIAsp50-BHI50, B:BHI50-BIAsp50 ) . Standard meal tests were performed at baseline and the ends of two periods within 4 weeks. Primary endpoint was 2h postprandial plasma glucose ( PPG) increment following standard meal test, with insulin dose standardized at 0. 3 IU/kg. Results A total of 161 subjects were randomized into two sequences(81 to sequence A, and 80 to sequence B) and finally analysed. After 4 weeks of treatment, mean 2h PPG increment with BIAsp50 was lower than that with BHI50 [ treatment difference of BIAsp50 vs BHI50: -1. 12 mmol/L ( 95% CI-1. 66,-0. 58), P<0. 01], suggesting superiority of BIAsp50 over BHI50. Incremental area under the curve for PPG(0-2 h)with BIAsp50 was lower than that with BHI50 [treatment difference:-38. 8 mmol·L-1·min-1(95%CI-77. 3,-0. 26), P=0. 049], as was the mean 2h PPG [treatment difference:-0. 58 mmol/L(95% CI -1. 13,-0. 03), P=0. 040]. The FPG value with BIAsp50 was higher than that with BHI50 [treatment difference:0. 52 mmol/L(95%CI 0. 18, 0. 86), P=0. 003]. The rate of nocturnal hypoglycemia with BIAsp50 was lower than that with BHI50(1. 13 vs 2. 86 events per subject year, P<0. 01). Conclusion In patients with T2DM inadequately controlled with BHI50 plus metformin, BIAsp50 was proven to be well-tolerated with improved postprandial glucose control compared with BHI50.

The role of mid-ratio premix insulin analogues in insulin treatment / 中国糖尿病杂志

[Summary] The characteristic feature of glucose profiles is high postprandial plasma glucose in Chinese T2DM patients. IDF Guideline recommends that T2DM patients whose postprandial plasma glucose cannot beadequately controlled by oral antidiabetic drugs ,should combine premixed insulin for treatment. Containing 50% insulin formulation for rapid action and 50% that for intermediate action ,mid‐ratio premix insulin analogues show exceptional characteristic of pharmacokinetics ,are able to efficiently improve high postprandial plasma glucose ,and ,with the route of administration flexible and convenience , can enhance patient compliance. Mid‐ratio premix insulin analogues can be one of the optimal option for T2DM treatment.

Comparison on the efficacy of biphasic insulin aspart 30 and premixed human insulin 30/70 through continuous glucose monitoring system / 中华流行病学杂志

Objective To compare the blood glucose levels and variability of premixed insulin aspart (BIAsp 30) with human insulin premix (BHI 30) used in a twice a day injection regimen in elderly type 2 diabetes patients. Methods 52 cases of inadequate glycemia controlled by oral anti-diabetic drugs were randomly divided into two groups, treated on a twice-daily regimen with BIAsp 30 (n=26) and BHI 30 (n=26) respectively. After achieving the target goal, a continuous glucose monitoring system (CGMS) was used to compare the blood glucose levels, blood glucose fluctuant coefficient (BGFC), postprandial glucose excursion (PPGE), and occurrence of hypoglycemia.Results BIAsp 30 was as effective as BHI 30 in controling glycaemia. Detected by CGMS, there was no statistical differences in blood glucose levels among pre-three main meals, post-lunch and the mean blood glucose (MBG) (all P＞0.05). The BGFC levels were significantly lower in the BIAsp 30 group than in the BHI 30 group [(1.69±0.42) mmol/L vs. (2.07 ±0.51)mmol/L,t=-3.013,P＜0.01]. The blood glucose increment over breakfast, dinner and the percentage of time at hyperglycaemia (BG ＞11.1 mmol/L) were lower in the BIAsp 30 group than in the BHI 30 group[(2.89± 1.32) mmol/Lvs.(3.83 ± 1.18) mmol/L, t=-2.705, P＜0.01; (2.69 ± 1.37) mmol/L vs. (3.55 ± 1.40) mmol/L, t=-2.232, P＜0.05; (6.21 ± 6.04)% vs. (10.01 ± 6.80)%, t=-2.132, P＜0.05]. The frequency of hypoglycemia was lower in the BIAsp 30 group than in the BHI 30 group, but there was no statistical difference (P＞0.05). Conclusion Pre-meal injection of BIAsp 30 in a twice-daily regimen could significantly improve the control of postprandial glucose level and reduce the overall glucose excursions so as to lower the risk of hypoglycaemia when compared to BHI 30.