预混胰岛素类似物强化治疗2型糖尿病临床观察

选取30例新诊断的严重（HbA1c〉9％）T2DM患者,和30例经两种或两种以上OADs治疗后血糖不达标（HbA1c〉7％）的T2DM患者为研究对象,应用双时相门冬胰岛素30每日二次或三次注射强化治疗,观察空腹血糖、餐后2h血糖、胰岛素用量及低血糖发生次数等指标的差异。结果：门冬胰岛素30强化控糖后两组性别、年龄、BMI、HbA1c、低血糖发生次数差异无统计学意义（P〉0．05）,（表1）;初发T2DM组强化治疗血糖达标时间及胰岛素用量明显低于已使用口服降糖药但血糖不达标的T2DM组,差异有统计学意义（P〈0．05）。（表2）。结论：预混胰岛素可作为胰岛素起始治疗方案,初发的T2DM尽早启动胰岛素治疗能够尽快纠正高血糖毒性,保护胰岛βp细胞功能。     

口服降糖药血糖控制不佳的老年2型糖尿病患者加用甘精胰岛素的疗效观察

目的通过比较甘精胰岛素和诺和灵N对口服降糖药血糖控制不佳的老年2型糖尿病患者的治疗效果,探讨甘精胰岛素在老年2型糖尿病患者血糖达标治疗中的临床运用价值。方法44例口服降糖药治疗空腹血糖控制不佳的老年2型糖尿病患者随机分为两组：甘精胰岛素治疗组22例,诺和灵N治疗组22例,治疗12周。观察两组治疗前后的糖化血红蛋白（HbA1c）值、空腹血糖（FBG）、餐后两小时血糖（2hPG）、体重指数（BMI）和每日所需的胰岛素剂量以及两组治疗过程中低血糖发生的频率。结果治疗12周后两组HbA1c、FBG、2hPG与治疗前比较差异有统计学意义（P〈0．05）;而两组间HbA1c、2hPG、低血糖事件的发生率比较差异有统计学意义（P〈0．05）,每日胰岛素的用量、BMI、FBG比较差异无统计学意义（P〉0．05）。结论加用甘精胰岛素对口服降糖药血糖控制不佳的老年2型糖尿病患者能更有效更安全地控制血糖。     

双时相门冬胰岛素30血糖控制疗效的预测因素分析A1 chieve研究亚组数据

目的 分析口服降糖药物控制不佳的2型糖尿病患者的基线情况对预混胰岛素疗效的影响.方法 A1chieve是一项为期24周的国际多中心、前瞻性、开放标签、非干预性的关于胰岛素类似物的研究.入选患者为经医师判断需要使用双时相门冬胰岛素30(门冬胰岛素30)的2型糖尿病患者,医师根据临床经验决定治疗方案并进行剂量调整,随访24周.主要安全性指标为:包括严重低血糖在内的严重药物不良反应(SADR).主要疗效指标包括糖化血红蛋白(HbA1 c),空腹血糖(FPG)和餐后2h血糖(2hPG)的变化.采用多因素回归分析基线因素中影响HbA1c达标的因素.结果 共有4 100例2型糖尿病患者起始双时相门冬胰岛素30治疗.4 100例中54.2％为男性,年龄(56.2±13.6)岁.研究期间未发生SADR.治疗后HbA1c由(9.3±2.1)％下降至(7.0±1.0)％;FPG由(10.2±3.3) mmol/L下降至(6.8±1.3) mmol/L;早、午、晚餐后2hPG的变化值分别为(-5.6±4.7)、(-4.9±4.3)、(-4.2±4.1)mmol/L(P值均＜0.001);HbA1c达标率(＜7.0％)由9.7％上升至54.2％.多因素logistic回归结果显示,基线HbA1c、FPG、2hPG与达标率呈负相关.结论 较低的基线HbA1c、FPG、2hPG是口服降糖药物血糖控制不佳的中国2型糖尿病患者接受门冬胰岛素30治疗24周后HbA1c达标(＜7.0％)的预测因素.提示口服降糖药治疗失败的患者,尽早起始双时相门冬胰岛素30治疗,更有助于血糖达标.     

双时相门冬胰岛素30联合二甲双胍治疗基础胰岛素控制不佳的2型糖尿病患者:疗效及安全性评价

目的 评价既往基础胰岛素联合口服降糖药物(OAD)治疗血糖控制不佳的2型糖尿病患者转用双时相门冬胰岛素30(BIAsp30)联合二甲双胍治疗的疗效及安全性.方法 本试验为多中心、非随机、开放、单组治疗达标研究,包括2周筛选期、4周导入期和16周治疗期.既往使用基础胰岛素联合OAD治疗血糖控制不佳的2型糖尿病患者转用每日两次BIAsp30注射联合口服二甲双胍治疗.收集疗效及安全性数据进行统计学分析.结果 共293例患者(男154,女139)入选,平均年龄(54.0±9.6)岁,平均糖尿病病程(8.54±5.49)年,平均体重指数(24.89±3.28)kg/m2,HbA1c 8.16%±0.89%,122例既往使用基础胰岛素类似物,169例使用人中效胰岛素.经16周的治疗,平均HbA1C降幅达1.30%±0.96%(P＜0.01);HbA1C达到＜7.0%和≤6.5%的患者比例分别为60.4%和38.9%.患者8点血糖谱各点血糖值均有显著降低(P＜0.01),8点血糖均值由基线时的(10.53±2.58)mmol/L降至(7.79±1.58)mmol/L(P＜0.01),降幅为2.76 mmol/L.早餐和晚餐后血糖增幅显著下降,分别下降了1.73 mmol/L(P＜0.01)和1.28 mmol/L(P＜0.01),而午餐后的血糖增幅未发现显著性降低(-0.09 mmol/L,P=0.734 5).研究治疗中无严重不良事件和重度低血糖事件报告,总体低血糖发生率为2.68例/患者年;患者体重平均增加(0.76±0.14)kg(P＜0.01).结论 BIAsp30联合二甲双胍可显著改善基础胰岛素联合OAD血糖控制不佳的2型糖尿病患者的血糖控制,并具有良好的安全性.     

诺和锐30治疗控制不良老年2型糖尿病临床体会

目的探讨预混胰岛素类似物双相门冬胰岛素（诺和锐30）对口服降糖药血糖控制不良的老年2型糖尿病的疗效和不良反应。方法：40例口服降糖药血糖控制不良的老年2型糖尿病使用诺和锐30治疗16周,观察治疗前后空腹血糖（FBG）、餐后血糖（PBG）、糖化血红蛋白（HbA1c）,并记录低血糖等不良反应。结果：FBG、PBG、HbA1c均明显下降,无严重低血糖及其它不良事件。结论：诺和锐30治疗口服降糖药血糖控制不良的老年2型糖尿病安全、有效。     

艾塞那肽对口服降糖药治疗欠佳的肥胖2型糖尿病患者的疗效及安全性

目的 评估艾塞那肽与双时相门冬胰岛素30在口服降糖药控制不佳的肥胖2型糖尿病患者中的疗效及安全性.方法 选取2010年2月至8月就诊的2型糖尿病患者,年龄＞35岁,体质指数(BMI)＞25 kg/m2,腰围男＞90cm,女＞85 cm,糖化血红蛋白(HbA1c)为7.5%～10.5%,二甲双胍与磺脲类降糖药治疗达12个...     

双时相门冬胰岛素30治疗老年2型糖尿病疗效观察

目的探讨双时相门冬胰岛素30对于老年2型糖尿病患者的疗效。方法将60例口服降糖药物血糖控制不理想的老年2型糖尿病患者随机分为两组各30例,治疗组给予双时相门冬胰岛素30 2次/d皮下注射,对照组给予预混人胰岛素30R 2次/d皮下注射,治疗3月后观察空腹血糖(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbA_(1c))的变化以及低血糖发生率。结果治疗3月后,两组患者FPG、2h PG及HbA_(1c)均较前明显降低。FPG降幅治疗组较对照组差异无统计学意义(P0.05);2h PG及HbA_(1c)降幅治疗组均较对照组更大,差异有统计学意义(P0.05)。低血糖发生率治疗组低于对照组,差异有统计学意义(P0.05)。结论对于老年2型糖尿病患者,双时相门冬胰岛素30具有依从性高、安全、有效等优势。     

江苏省2型糖尿病患者血糖控制及治疗用药情况调查

目的了解江苏省2型糖尿病（T2DM）患者的血糖控制情况,分析治疗方法与血糖控制的关系。方法采用横断面研究方法,以调查问卷形式收集患者年龄、病程、降糖药物的使用情况等,留取血标本检测HbA1c。根据HbA1c水平将患者分为达标组（HbA1c〈6．5％）和未达标组（HbA1c≥6．5％）;根据降糖治疗情况分为胰岛素（Ins）组、胰岛素联用口服降糖药（Ins＋OA）组、口服降糖药（OA）组、生活方式干预（LS）组。结果入选T2DM患者2966例,年龄（56．4±11．2）岁,糖尿病平均病程（6．3±5．7）年,HbA1c值（7．2±1．6）％,HbA1c≥6．5％的患者占59．8％。（1）平均病程Ins组[（7．6±6．5）年]与Ins＋OA组[（8．2±6．2）年]均高于OA组C（5．3±5．0）年]（P〈0．01）。HbA1c均值及未达标比例Ins组[（7．4±1．6）％,未达标比例65．9％]与Ins＋OA组[（7．5±1．5）％,未达标比例77．9％]均高于OA组[（7．0±1．6）％,未达标比例52．4％]（P〈0．01）。（2）HbA1c达标组与未达标组病程分别为（4．8±4．9）年和（7．3±6．1）年（P〈0．01）,两组中胰岛素联合口服降糖药治疗者分别占11．5％和27．2％（P〈0．01）,单用胰岛素治疗者分别占17．0％和22．1％（P〈0．01）。结论江苏省T2DM患者血糖控制现状比3年前全国调查情况有所改善,但仍有相当比例的患者HbA1c水平没有达到IDF及《中国2型糖尿病防治指南》推荐标准。接受胰岛素治疗的患者HbA1c均值及不达标比例明显高于其他治疗组,表明由于病程延长及口服降糖药用药失效导致病情恶化后,再选择胰岛素治疗,血糖控制情况并不理想。     

每日1次双时相门冬胰岛素30与甘精胰岛素治疗2型糖尿病患者的比较——Easymix研究中国亚组结果

目的 观察比较对于口服降糖药治疗效果不佳的中国T2DM患者,每日1次双时相门冬胰岛素30（BIAsp30）与甘精胰岛素的有效性及安全性. 方法 采用开放、随机、多中心的平行对照法,纳入口服降糖药治疗效果不佳且未长期使用胰岛素的T2DM患者,随机接受每日晚餐前1次BIAsp30或每日睡前1次甘精胰岛素,联合二甲双胍及格列美脲治疗24周后评价有效性及安全性. 结果 BIAsp30组210例,甘精胰岛素组212例.治疗结束时,BIAsp30组和甘精胰岛素组HbA1c分别较基线值下降-0.75％和-0.66％（BIAsp30组一甘精胰岛素组=0.08％,95％ CI：-0.23～0.07）.BIAsp30组晚餐后和睡前血糖水平低于甘精胰岛素组（P＜0.01）,而晚餐前血糖水平则高于甘精胰岛素组（P＜0.01）.BIAsp30组餐后血糖增量均值变化及晚餐后血糖增量的变化优于甘精胰岛素组.两组间低血糖事件和不良反应发生情况差异无统计学意义. 结论 以HbA1c作为有效性指标,每日注射1次BI-Asp30作为中国T2DM患者的胰岛素起始方案不劣于每日注射1次甘精胰岛素,且不增加低血糖事件及发生不良反应的风险.     

糖尿病患者接受双时相门冬胰岛素30治疗时的临床基线情况——IMPROVE^TM研究中国亚组结果

目的选取IMPROVE^TM的中国亚组数据,了解中国糖尿病患者治疗时的基线特征。方法经临床医生判断预启用BIAsp30治疗的糖尿病患者为人选对象。由医生记录基线时的人口统计学数据、病史、起始BIAsp30治疗的原因、血糖控制情况和具体治疗方案。结果共人选糖尿病患者21729例（女性37％,男性63％）,平均糖尿病病程（4．86±4．98）年,2型糖尿病（T2DM）患者占99．7％,平均年龄（54．0±12．7）岁,平均体重指数BMI（24．63±3．12）kg／m^2。24％的受试者患有大血管并发症;40．5％患有微血管并发症。基线时,32．3％的患者从未进行过降糖治疗,59．3％仅接受过口服降糖药（OHA）治疗,8．1％单独应用胰岛素或联合OHA治疗。受试者基线时平均糖化血红蛋白（HbA1c）为（9．46±2．04）％。转用BIAsp30治疗的最主要原因是期望改善血糖控制,89．1％的患者采用了每日2次的给药方式。结论中国糖尿病患者血糖控制差且并发症发生率高,糖尿病治疗尤其是胰岛素治疗的开展是滞后的。     

Multiple mealtime administration of biphasic insulin aspart 30 versus traditional basal-bolus human insulin treatment in patients with type 1 diabetes

AIM: The aim of this study was to compare the effect of multiple mealtime injections of biphasic insulin aspart 30 (30% fast-acting insulin aspart in the formulation, BIAsp30) to traditional basal-bolus human insulin regimen (HI) on glycaemic control in patients with type 1 diabetes. METHODS: Twenty-three patients (eight women and 15 men) aged 44.8 (20.6-62.5) years (median and range) with a diabetes duration of 19.5 (1.6-44.6) years completed the study. All eligible patients were randomly assigned to BIAsp30 thrice daily supplied with bedtime NPH insulin when necessary, or basal-bolus HI for 12 weeks and then switched to the alternative regimen for another 12 weeks. The insulin dose adjustments were made by patients on the basis of advice from a diabetes nurse. At end of each treatment period, the patients attended two profile days, 1 week apart for pharmacodynamic and pharmacokinetic assessments. HbA1C was measured at baseline and at the end of each treatment period. A seven-point self-monitored blood glucose (SMBG) was obtained twice weekly. RESULTS: In comparison with HI, multiple mealtime injections of BIAsp30 resulted in a significant reduction in HbA1C[HI vs. BIAsp30 (%, geometric mean and range): 8.6 (7.4-11.4) vs. 8.3 (6.7-9.8), p = 0.013]. During treatment with BIAsp30, nighttime glycaemic control was significantly improved. Day-to-day variation in pharmacodynamics and pharmacokinetics and the rate of hypoglycaemia were not increased with BIAsp30 compared with HI. Conclusions: In type 1 diabetics, multiple mealtime administration of BIAsp30 compared with traditional basal-bolus human insulin treatment significantly improves long-term glycaemic control without increasing the risk of hypoglycaemia. Despite a higher proportion of intermediate-acting insulin, thrice-daily injections with BIAsp30 do not increase the day-to-day variations in insulin pharmacokinetics and pharmacodynamics.     

Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study)

AIM: This observational study in patients with type 2 diabetes failing oral agent therapy with or without basal insulin was conducted to assess whether addition and self-titration of biphasic insulin aspart 70/30 (BIAsp 30) could achieve American Association of Clinical Endocrinologists (AACE)/International Diabetes Federation (IDF) and American Diabetes Association (ADA) glycemic targets (HbA(1c)< or =6.5 and <7%). METHODS: Enrolled patients (n = 100, HbA(1c)> or =7.5 and < or =10%) were > or =18 years of age, had diabetes > or =12 months and had received a stable antidiabetic regimen for at least 3 months [minimum of two oral antidiabetic drugs (OADs) or at least one OAD plus once-daily basal insulin < or =60 U]. Patients discontinued prior basal insulin and added one injection of BIAsp 30 (12 U or 70-100% of prior basal insulin dose within 15 min of dinner initiation). Patients self-titrated their BIAsp 30 dose with investigator guidance every 3 or 4 days to achieve pre-breakfast fasting blood glucose (FBG) of 80-110 mg/dl. At 16 weeks, a pre-breakfast injection of 6 U of BIAsp 30 was added if week 15 HbA(1c) exceeded 6.5%; the added dose was titrated to achieve pre-dinner BG of 80-110 mg/dl. After an additional 16 weeks, 3 U of pre-lunch BIAsp 30 was added if HbA(1c) exceeded 6.5%. This added dose was adjusted based on 2-h post-lunch BG to achieve postprandial glucose of 100-140 mg/dl. Subjects achieving an HbA(1c)< or =6.5% at 15 and 31 weeks completed the study at weeks 16 and 32 respectively. RESULTS: Addition of once-daily BIAsp 30 before dinner enabled 21% of the patients to achieve AACE and IDF targets (HbA(1c)< or =6.5%) and 41% to achieve ADA targets (HbA(1c) <7%). With two daily injections of BIAsp 30, these glycaemic goals were achieved by 52 and 70% of subjects. With three daily BIAsp 30 injections, 60% of patients achieved HbA(1c)< or =6.5%, and 77% achieved HbA(1c) <7.0%. CONCLUSIONS: This clinical trial demonstrates that initiation of once-daily BIAsp 30 to type 2 diabetes patients poorly controlled on various OAD regimens was an effective treatment approach for achieving glycaemic goals. Additional patients safely achieved these goals by increasing the number of BIAsp 30 injections from one to two, and then, if uncontrolled, from two to three doses per day. Eventually, most patients previously uncontrolled on OADs with or without basal insulin were controlled by the addition and vigorous titration of BIAsp 30 to oral agent therapy.     

Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries

Aims

This subanalysis of the SoliMix trial assessed the efficacy and safety of advancing basal insulin (BI) therapy with iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D) living in Latin American (LATAM) countries, i.e. Argentina and Mexico (N = 160).

Materials and Methods

SoliMix (EudraCT: 2017-003370-13) was a 26-week, open-label, multicentre study, where adults with T2D suboptimally controlled with BI plus one or two oral glucose-lowering drugs and glycated haemoglobin (HbA1c) ≥7.5% to ≤10% were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy endpoints were non-inferiority in HbA1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30.

Results

Both primary efficacy endpoints were met in the LATAM region. After 26 weeks, HbA1c was reduced by 1.8% with iGlarLixi and 1.4% with BIAsp 30, meeting non-inferiority [least squares mean difference −0.47% (95% confidence interval: −0.82, −0.11); p < .001]. iGlarLixi was superior to BIAsp 30 for body weight change [least squares mean difference −1.27% (95% confidence interval: −2.41, −0.14); p = .028]. iGlarLixi was also superior to BIAsp 30 for HbA1c reduction (p = .010). A greater proportion of participants achieved HbA1c <7% without weight gain and HbA1c <7% without weight gain and without hypoglycaemia with iGlarLixi versus BIAsp 30. Incidence and rates of American Diabetes Association Level 1 and 2 hypoglycaemia were lower with iGlarLixi versus BIAsp 30.

Conclusions

Once-daily iGlarLixi provided better glycaemic control with weight benefit and less hypoglycaemia than twice-daily premix BIAsp 30. iGlarLixi may be a favourable alternative to premix BIAsp 30 in people with suboptimally controlled T2D to advance BI therapy in the LATAM region.     

Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes

AIM: This study compared glycaemic control achieved with biphasic insulin aspart 30 (BIAsp 30) monotherapy, BIAsp 30 plus metformin and glibenclamide plus metformin in patients with type 2 diabetes not adequately controlled with metformin. METHODS: In this multinational, open-labelled, parallel group, 16-week trial, 341 patients (patients not adequately controlled with metformin for at least 1 month) with type 2 diabetes were studied. Patients were randomized to receive BIAsp 30, twice daily (n = 107 exposed to treatment), or BIAsp 30, twice daily, plus metformin (n = 108) or glibenclamide plus metformin (n = 114). The primary endpoint was HbA(1c) at end of trial; adverse events, hypoglycaemia episodes, blood lipids and weight were also monitored. RESULTS: In the total population (HbA(1c) 7.5-13.0% at screening), end-of-trial HbA(1c) levels were lower in patients receiving BIAsp 30 plus metformin compared with those receiving BIAsp 30 only [mean treatment difference (+/-s.e.m), 0.39 +/- 0.15%, p = 0.007]. In a subpopulation (HbA(1c) > or = 9.0% at baseline, n = 193), patients receiving BIAsp 30 plus metformin had significantly lower HbA(1c) levels at the end of the trial compared with those receiving glibenclamide plus metformin (treatment difference, 0.46 +/- 0.21%, p = 0.027). Mean body weight (+/-s.d) at the end of the trial was significantly lower in patients receiving glibenclamide plus metformin compared with those receiving BIAsp 30 only (84.3 +/- 13.3 kg vs. 88.9 +/- 16.9 kg, p < 0.001). No major hypoglycaemic episodes were recorded during the trial, and incidence rates for minor and symptoms-only hypoglycaemia were low and similar between treatment groups (0.03-0.04 events/patient/week). CONCLUSION: BIAsp 30 added to metformin could be an appropriate therapeutic option for achieving good glycaemic control, compared with the addition of a second oral agent, particularly where HbA(1c) > or = 9%.     

Study design and baseline characteristics of patients in the PRESENT study

PRESENT (Physicians' Routine Evaluation of Safety & Efficacy of NovoMix 30 Therapy) is a 6-month observational study of safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in 31,044 type 2 diabetes patients from 15 countries. The aim of this article is to describe the study protocol and assess baseline characteristics of patients in various countries according to diabetes duration (<5 years, 5 to or=20 years), to improve treatment decisions in clinical practice. Glycaemic control was similar across all groups: HbA1c 9.3-9.4%; fasting plasma glucose 11.3-11.6 mmol/L; postprandial glucose 15.9-16.3 mmol/L. Major hypoglycaemia was reported by 5% of all patients, minor hypoglycaemia increased with diabetes duration (25.4-30.3%); overall hypoglycaemia rate was 6.7 events/patient/year. Complications increased with diabetes duration; the most reported were hypertension (40.6-71.0%) and hyperlipidaemia (39.4-56.6%). Of patients 38% previously received OADs only, 28% insulin only, 19% insulin with OADs, and 13% received no therapy. Glycaemic control appeared independent of diabetes duration. HbA1c was well above targets and the clinical inertia was quite apparent; even patients with diabetes for <5 years had high HbA1c levels. Patients suffered high rates of complications and hypoglycaemia before starting BIAsp 30 therapy.     

诺和锐(R)30治疗2型糖尿病有效性和安全性研究——PRESENT大型临床观察研究中国区结果报道

目的 PRESENT(Physicians' Routine Evaluation of Safety and Efficacv of NovoMixR 30Therapy)为多中心、前瞻性、开放性国际多中心临床观察研究,目的 是评价口服药降糖控制不良的2型糖尿病患者使用预混人胰岛素类似物(诺和锐R 30)的有效性、安全性和治疗满意度.本研究来源于PRESENT中国区研究结果.方法 共4754例以往使用口服降糖药治疗的2型糖尿病患者参与了本研究.参与研究的医生按照产品说明书处方诺和锐R 30特充R,并在基线和治疗后3个月分别收集患者的临床数据.结果 患者基线平均HbA1c(9.09±1.70)%,体重指数(BMI)为(24.30±2.68)kg/m2,年龄(54.63±10.94)岁,糖尿病病程(5.46±4.17)年.治疗开始和3个月后,诺和锐R 30平均日剂量分别为(0.43±0.14)U/kg和(0.48±0.15)U/kg.3个月后,平均HbA1c、空腹血糖(FPG)和餐后血糖(PPG)显著降低[分别下降(2.04±1.57)%、(3.51±2.55)mmoL/L、(6.51±4.02)mmol/L,均P<0.01],49.4%的患者达到HbA1c<7%的治疗标准.总体低血糖事件(件/患者年)从基线时10.098下降至3.810,重度低血糖事件从0.787下降至0.126,夜间低血糖事件从2.356下降至0.547.与以往治疗相比,超过99%的医生和患者对使用诺和锐R 30特充R治疗表示"满意"或"非常满意".结论 口服降糖药血糖控制不良的2型糖尿病患者,使用诺和锐R 30特充R可有效改善血糖控制水平,提高治疗达标率,同时降低低血糖发生风险.     

Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients.

AIM: To compare the efficacy and safety of premixed insulin aspart (30% free and 70% protamine-bound, BIAsp 30) with human insulin premix (BHI 30) used in a twice-daily injection regimen in people with Type 1 and Type 2 diabetes. METHODS: People with Type 1 and Type 2 diabetes (n = 294) using twice-daily insulin were randomized to a 12-week open-label comparison of BIAsp 30 and BHI 30. Efficacy was assessed by analysis of variance of 12-week data, adjusted for baseline level. RESULTS: BIAsp 30 was as effective as BHI 30 based on the primary efficacy measure, HbA1c, mean difference -0.01 (90% confidence interval (CI) -0.14; 0.12) %Hb. Meal-time self-measured blood glucose increment averaged over the three main meals was significantly lower in the BIAsp 30 group than in the BHI 30 group (-0.68 (-1.20; -0.16) mmol/l; P < 0.02). Significant improvements were observed after breakfast, before lunch, after dinner and at bedtime (P < 0.02-0.05), with blood glucose around 1.0 mmol/l lower in the BIAsp 30 group. The number of major hypoglycaemic episodes with BIAsp 30 was half that with BHI 30. However, the overall risk of both minor and major hypoglycaemia did not differ significantly between treatments. CONCLUSION: Post-prandial glycaemic control was significantly improved, without increasing the risk of hypoglycaemia, and overall control was similar when people with Type 1 and Type 2 diabetes were treated on a twice-daily regimen with immediate premeal injections of BIAsp 30 compared with BHI 30.