预混门冬胰岛素30和预混人胰岛素30R治疗2型糖尿病的临床比较

目的 探讨每日2次注射预混门冬胰岛素30(诺和锐30特充)和预混人胰岛素30R(诺和灵30R)治疗口服降糖药效果不佳的2型糖尿病的疗效及低血糖风险.方法 68例经口服降糖药物控制不佳的2型糖尿病患者,根据入院先后按11比例随机分为诺和锐30组和诺和灵30R组.入选病例在继续服用除胰岛素促泌剂以外的口服降糖药的基础上,分别采用每日早晚餐前注射诺和锐30和诺和灵30R,进行为期12周的观察.比较12周后两组HbA1c、八点血糖及曲线下面积、日均血糖和低血糖发生频率等.结果 ①两组治疗后空腹血糖、HbA1c均显著下降,提示诺和锐30和诺和灵30R治疗2型糖尿病均有效.②诺和锐30组的早晚餐后2 h、中餐前、睡前血糖均显著低于诺和灵30R组(P＜0.01),日均血糖和八点血糖曲线下面积也有所改善.③诺和锐30组低血糖发生次数低于诺和灵30R组,但差异无统计学意义(P＞0.05),诺和锐30组无严重低血糖发生.结论 对于2型糖尿病患者,每日两次注射诺和锐30较诺和灵30R能更明显地降低餐后血糖、日均血糖及减少低血糖风险,同时更易于为患者接受.     

A direct comparison of insulin aspart and insulin lispro in patients with type 1 diabetes

OBJECTIVE: Both rapid-acting insulin analogs, insulin aspart and lispro, attenuate prandial glucose excursion compared with human soluble insulin. This trial was performed to study the pharmacokinetic and pharmacodynamic profiles of insulin aspart and insulin lispro in type 1 diabetic patients in a direct comparison and to investigate whether the administration of one analog results in favorable effects on prandial blood glucose control. RESEARCH DESIGN AND METHODS: A total of 24 type 1 diabetic patients (age 36 +/- 8 years, 16 men and 8 women, BMI 24.3 +/- 2.6 kg/m(2), diabetes duration 17 +/- 11 years, HbA(1c) 7.9 +/- 0.8%) on intensified insulin therapy were recruited into a single-center, randomized, double-blind, two-period, cross-over, glucose clamp trial. The subjects were given an individual need-derived dose of prandial insulin lispro or aspart immediately before a standard mixed meal. RESULTS: With respect to blood glucose excursions from time 0 to 6 h (Exc(glu(0-6 h))) and from time 0 to 4 h (Exc(glu(0-4 h))), the pharmacodynamic effect of insulin aspart and insulin lispro can be declared equivalent. This was supported by comparison with maximum postprandial blood glucose excursions (C(max(glu))) (estimated ratio aspart/lispro ANOVA [90% CI]: 0.95 [0.80-1.13], 0.97 [0.82-1.17], and 1.01 [0.95-1.07] for Exc(glu(0-6 h)), Exc(glu(0-4 h)), and C(max(glu)), respectively). For pharmacokinetic end points (maximum postprandial insulin excursions and area under the curve for insulin from time 0 to 6 h and from time 0 to 4 h), equivalence was indicated. No difference concerning absorption or elimination for time to maximal insulin concentration, time to half-maximum insulin concentration, and time to decrease to 50% of maximum insulin concentration was observed. CONCLUSIONS: These data suggest that in type 1 diabetic patients, both insulin analogs are equally effective for control of postprandial blood glucose excursions.     

双时相门冬胰岛素30与预混人胰岛素30R治疗2型糖尿病的疗效及安全性比较

目的比较双时相门冬胰岛素30和预混人胰岛素30R治疗2型糖尿病(T2DM)的疗效及安全性。方法将本院2007年1月至2010年5月住院的80例T2DM患者采用简单随机方法分为两组,其中预混人胰岛素30R治疗40例(A组),双时相门冬胰岛素30治疗40例(B组),均采用每日早、晚餐前两次皮下注射方案,为期12周,比较两组患者空腹、早餐后2 h、午餐前、午餐后2 h、晚餐前、晚餐后2 h及睡前7个时点血糖的变化,糖化血红蛋白(HbA1 c)及血糖控制达标所需要的胰岛素用量、低血糖事件、不良反应发生率。结果 B组三餐后血糖、HbA1 c、低血糖事件发生率均低于A组,差异有统计学意义(P<0.05);两组胰岛素用量及其他不良事件发生率差异无统计学意义(P>0.05)。结论双时相门冬胰岛素30能有效降低餐后血糖,且低血糖事件发生率低,是一种简便、有效、安全的治疗方法。     

Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix® 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6‐month IMPROVE™ observational study

Aims: IMPROVE? is an open‐label, multinational, non‐randomised, 26‐week observational study designed to evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in routine clinical practice. Here, we report data for patients switching to BIAsp 30 from human premixed insulin. Methods: Patients (n = 3856) with type 2 diabetes previously receiving human premixed insulin with or without oral antidiabetic drugs were eligible for inclusion. Demographic data, efficacy end‐points (HbA_1c, fasting blood glucose and postprandial blood glucose) and safety end‐points (serious adverse drug reactions, hypoglycaemia and adverse events) were collected at baseline and final visit. A subgroup analysis of mean dose change was also undertaken. Results: Switching patients to BIAsp 30 resulted in significant improvements in glycaemic control combined with a reduced risk of hypoglycaemia. Patients who reached the HbA_1c target (< 7%) had shorter diabetes duration, lower HbA_1c at baseline and needed less insulin. Over 30% of patients were able to reach this target without experiencing hypoglycaemia over the 26‐week period. Compared with asymmetric dose switching, unit‐for‐unit switching resulted in the highest proportion of patients reaching HbA_1c target and incurred the least amount of dose titration. Conclusions: A unit‐for‐unit switch is the most effective as well as the simplest approach when transferring patients from biphasic human insulin 30 to BIAsp 30.     

Initiating insulin therapy with,or switching existing insulin therapy to,biphasic insulin aspart 30/70 (NovoMix® 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE™ observational study

Aims: The IMPROVE? observational study evaluated the safety profile and effectiveness of biphasic insulin aspart 30/70 (BIAsp 30) in patients with type 2 diabetes in routine practice in 11 countries. Methods: Patients who initiated insulin therapy with, or switched existing insulin therapy to, BIAsp 30 in routine care were eligible for this 26‐week, non‐interventional observational study. Data on adverse events, hypoglycaemia and glycaemic parameters were obtained from patients’ diaries and medical notes. Questionnaire‐based patient treatment satisfaction was also measured. We report global results and, uniquely for a diabetes observational study, country‐specific data. Results: A total of 52,419 patients were enrolled from three prestudy treatment groups: no pharmaceutical therapy (n = 8966, diabetes duration 2.0 years, baseline HbA_1c 9.9%), oral antidiabetic drugs (OADs) only (n = 33,797, diabetes duration 7.4 years, baseline HbA_1c 9.2%) and insulin ± OADs (n = 9568, diabetes duration 10.4 years, baseline HbA_1c 9.3%). At final visit, HbA_1c, fasting and postprandial blood glucose were significantly reduced from baseline in all subgroups (no pharmaceutical therapy: ?3.1%, ?5.9 and ?9.0 mmol/l, respectively; OADs‐only: ?2.1%, ?4.1 and ?6.1 mmol/l; insulin ± OADs: ?2.0%, ?3.3 and ?5.1 mmol/l). Major hypoglycaemia rates decreased in all subgroups; minor hypoglycaemia increased in the insulin‐naïve groups. There was no mean weight gain across subgroups. Across all countries, glycaemic parameters and major hypoglycaemia were reduced; weight increases were seen in some countries. Treatment satisfaction increased in all subgroups and countries following BIAsp 30 therapy. Conclusions: Initiating insulin with, or switching insulin therapy to, BIAsp 30 in routine care resulted in improved glycaemic control, reduced major hypoglycaemia and greater treatment satisfaction.     

双时相门冬胰岛素30针治疗老年2型糖尿病的疗效及安全性

目的探讨双时相门冬胰岛素30针治疗老年2型糖尿病患者的疗效及安全性。方法血糖控制欠佳,年龄≥70岁的老年2型糖尿病患者68例,随机分成两组,试验组采用双时相门冬胰岛素30针治疗,对照组采用精蛋白生物合成人胰岛素注射液治疗,共12周,测定治疗前后空腹、餐后2h血糖、糖化血红蛋白的变化以及观察不良反应的发生率。结果试验组治疗12周后空腹血糖、餐后2h血糖和糖化血红蛋白均下降,与治疗前比较,差异均有统计学意义（t分别=5.12、4.35、4.64,P均〈0.05）;治疗后两组空腹血糖、餐后2h血糖和糖化白红蛋白差值比较,差异均无统计学意义（t分别=1.50、1.04、0.89,P均〉0.05）。低血糖发生率试验组6例明显低于对照组18例,差异有统计学意义（χ^2=7.64,P均〈0.05）。结论在老年2型糖尿病患者中使用双时相门冬胰岛素30针治疗效果好,使用方便,安全性好。     

Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes

OBJECTIVE—The purpose of this study was to evaluate the 2-year pulmonary safety of inhaled human insulin (Exubera [EXU]) in 635 nonsmoking adults with type 2 diabetes.RESEARCH DESIGN AND METHODS—Patients were randomly assigned to receive prandial EXU or subcutaneous insulin (regular or short-acting) plus basal (intermediate- or long-acting) insulin. The primary end points were the annual rate of decline in forced expiratory volume in 1 s (FEV₁) and carbon monoxide diffusing capacity (DL_CO).RESULTS—Small differences in FEV₁ favoring subcutaneous insulin developed during the first 3 months but did not progress. Adjusted treatment group differences in FEV₁ annual rate of change were −0.007 l/year (90% CI −0.021 to 0.006) between months 0 and 24 and 0.000 l/year (−0.016 to 0.016) during months 3–24. Treatment group differences in DL_CO annual rate of change were not significant. Both groups sustained similar reductions in A1C by month 24 (last observation carried forward) (EXU 7.7–7.3% vs. subcutaneous insulin 7.8–7.3%). Reductions in fasting plasma glucose (FPG) were greater with EXU than with subcutaneous insulin (adjusted mean treatment difference −12.4 mg/dl [90% CI −19.7 to −5.0]). Incidence of hypoglycemia was comparable in both groups. Weight increased less with EXU than with subcutaneous insulin (−1.3 kg [−1.9 to −0.7]). Adverse events were comparable, except for a higher incidence of mild cough and dyspnea with EXU.CONCLUSIONS—Two-year prandial EXU therapy showed a small nonprogressive difference in FEV₁ and comparable sustained A1C improvement but lower FPG levels and less weight gain than seen in association with subcutaneous insulin in adults with type 2 diabetes.Inhaled human insulin (Exubera [EXU], insulin human [rDNA origin] inhalation powder) is effective in patients with type 2 diabetes in whom glycemic control is not achieved with diet and exercise (1) and provides better glycemic control in patients whose diabetes remains inadequately controlled with either monoagent or combination oral agent regimens (2–5). In addition, 6-month EXU therapy is at least comparable in efficacy to subcutaneous insulin therapy in type 2 diabetes (6).Previous controlled studies of EXU in type 2 diabetic patients have shown slight but consistent treatment group differences in pulmonary function in favor of comparators, using nonstandardized lung function testing (3–6). These small differences occurred early, did not progress for up to 2 years, and were not clinically meaningful. However, these studies were not designed specifically to examine respiratory safety primary end points.The aim of the present study was to provide a robust evaluation of the long-term pulmonary safety of EXU versus subcutaneous insulin. Adult patients with type 2 diabetes were evaluated by means of validated, highly standardized pulmonary function testing, trained coordinators, and centralized data collection (7–10). A secondary objective was to evaluate the long-term efficacy of EXU versus subcutaneous insulin.     

双时相门冬胰岛素30对2型糖尿病患者血糖的影响

目的分析2型糖尿病患者口服降糖药控制不满意时加用双时相门冬胰岛素30治疗前后血糖水平的变化,探讨其降糖作用。方法 40例2型糖尿病患者口服降糖药控制不满意时加用双时相门冬胰岛素30治疗24周,观察治疗前后血糖等指标的变化。结果双时相门冬胰岛素30治疗后空腹血糖(FPG)、餐后2 h血糖(PPG)、糖化血红蛋白(HbA1c)、甘油三酯(TG)水平较治疗前显著降低,患者加用双时相门冬胰岛素30治疗后,HbA1c水平<7%及≤6.5%者所占比例较治疗前显著增加。结论双时相门冬胰岛素30可改善口服降糖药控制不满意时2型糖尿病患者的血糖控制及血脂代谢,有助于降低2型糖尿病患者并发症,改善预后。     

Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetes mellitus: A meta-analysis

Background: Insulin is recommended as a second-line treatment after diet and metformin fail to reach and/or maintain glycemic targets considered to minimize the risk for long-term diabetic complications. Hypoglycemia and the fear of developing hypoglyce-mia, however, remain substantial barriers to the initiation and optimal use of insulin.Objective: The aim of this study was to compare biphasic insulin aspart 30 (BIAsp 30) with biphasic human insulin 30 (BHI 30) with respect to glycemic control and the risk for hypoglycemia using a meta-analysis of clinical trials comparing these insulins in patients with type 2 diabetes mellitus (T2DM).Methods: We included all published and unpublished, randomized, controlled trials in adult patients with T2DM (treatment duration ≥12 weeks) for which individual patient data were available. All clinical databases and local trial registries of Novo Nordisk A/S (Soeborg, Denmark) were searched to identify clinical trials comparing the 2 products. The predefined primary end point of the study was the overall rate of nocturnal hypoglyce-mia (major, minor, and symptoms-only hypoglycemia occurring from 12:00–6:00 AM). Hypoglycemia was analyzed using a negative binomial distribution model, accounting for exposure time. Glycemic end points were analyzed at 12 to 16 weeks of treatment using ANCOVA, adjusting for baseline. Secondary safety end points were the rates of major hypoglycemia (hypoglycemia requiring third-party assistance), minor hypoglycemia (symptoms confirmed by plasma glucose [PG] <3.1 mmol/L), daytime hypoglycemia (major, minor, and symptoms-only hypoglycemia occurring from 6:01 AM–11:59 PM), overall hypoglycemia (the sum of all major, minor, and symptoms-only episodes), and change in weight from baseline to 12 to 16 weeks of treatment. Secondary efficacy end points were changes in glycosylated hemoglobin (HbA_1c), fasting PG (FPG), postprandial PG increment (averaged over breakfast, lunch, and dinner), and insulin dose.Results: Nine randomized, parallel or crossover trials were included (N = 1674; male sex, 57%; mean [SD] age, 61.0 [10.6] years; body mass index, 26.7 [4.6] kg/m²; HbA_1c, 8.1% [1.4%]; duration of diabetes, 10.9 [7.9] years). Rates of overall hypoglycemia were not significantly different (rate ratio [RR] = 1.08; 95% CI, 0.94–1.24; P = NS) between treatments. BIAsp 30 had a 50% lower rate of nocturnal hypoglycemia than BHI 30 (RR = 0.50; 95% CI, 0.38–0.67; P < 0.01), whereas the rate of daytime hypoglycemia was 24% lower for BHI 30 (RR = 1.24; 95% CI, 1.08–1.43; P < 0.01). The likelihood of major hypo-glycemia was significantly lower with BIAsp 30 compared with BHI 30 (odds ratio = 0.45; 95% CI, 0.22–0.93; P < 0.05). BIAsp 30 was associated with reduced PPG increment (averaged over breakfast, lunch and dinner) compared with BHI 30 (treatment difference, ?0.31; 95% CI, ?0.49 to ?0.07; P < 0.01). There was a significantly larger reduction in FPG associated with BHI 30 (treatment difference, 0.63; 95% CI, 0.31–0.95; P < 0.01). However, no significant treatment difference was found for HbA_1c (treatment difference, 0.04; 95% CI, ?0.02 to 0.10; P = NS).Conclusion: This meta-analysis found BIAsp 30 to be associated with a significantly lower rate of nocturnal and major hypoglycemia, but a significantly increased risk for daytime hypoglycemia, compared with BHI 30 at a similar level of HbA_1c in patients with T2DM.     

两种胰岛素类似物治疗2型糖尿病的比较

目的探讨预混胰岛素类似物门冬胰岛素30注射液（诺和锐30）和长效胰岛素类似物甘精胰岛素注射液（来得时）治疗2型糖尿病的疗效和安全性。方法 83例初诊2型糖尿病随机分成2组,分别给予诺和锐30每天2次及来得时每天1次治疗12周,观察治疗前后空腹血糖（FPG）、餐后2小时血糖（PPG）、糖化血红蛋白（HbA1c）的变化,比较两组血糖达标率、低血糖的发生率。结果诺和锐30组HbA1c较来得时治疗组明显下降,HbA1c（7.42±1.38）%vs（8.31±1.82）%（P〈0.05）。诺和锐30组PPG显著低于来得时组,（7.82±4.18）mmol/L vs（8.21±3.90）mmol/L（P〈0.05）。诺和锐30组PPG达标率更高,83.0%vs 56.1%（P〈0.05）,达标时间更短,（7.85±1.48）天vs（8.25±2.46）天,但低血糖事件较来得时组略高,26.2%vs 12.2%（P〈0.05）。诺和锐30组胰岛素用量高于来得时组,（0.61±0.24）U/kg vs（0.50±0.27）U/kg（P〈0.05）,体质量增加也较明显,（5.6±4.6）kg vs（3.0±4.3）kg（P〈0.05）。结论诺和锐30每天2次治疗比来得时每天1次治疗能更有效地降低血糖,血糖达标时间更短,但低血糖发生率略高。     

Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus

OBJECTIVE: The purpose of this study was to compare the pharmacokinetics and pharmacodynamics of the premixed insulin analogue biphasic insulin aspart (BIAsp 30) with the equivalent premixed biphasic human insulin (BHI 30), administered twice daily, in patients with type 2 diabetes mellitus. METHODS: In this randomized, double-blind, crossover trial, 13 patients (mean age, 64 years; baseline mean glycosylated hemoglobin, 7.7%; mean body mass index, 28.1 kg/m2) received 2 weeks of treatment with BIAsp 30 and 2 weeks of BHI 30 administered immediately before dinner and breakfast. At the end of each 2-week treatment period, 24-hour serum insulin and glucose profiles were determined using specific 2-sided enzyme-linked immunosorbent assays. All pharmacodynamic and pharmacokinetic end points were analyzed using analysis of variance. RESULTS: Total daily insulin exposure was similar between treatment periods. Mean area under the total insulin concentration-time profile during the 2 hours following administration of BIAsp 30 was 17% greater than that of BHI 30 after dinner and 44% greater after breakfast; both differences were statistically significant. The maximum serum insulin aspart concentrations following BIAsp 30 were significantly higher after dinner (18%) and breakfast (35%). Peak serum insulin concentration was reached 1 hour earlier after breakfast and 45 minutes earlier after dinner in the BIAsp 30 group; differences were significant only after breakfast. The mean daily prandial glucose excursion was significantly lower for BIAsp 30 (16.2 mmol x h x L(-1)) than BHI 30 (17.9 mmol x h x L(-1)). Postprandial 4-hour glucose excursions were significantly lower with BIAsp 30 than with BHI 30 after dinner and breakfast, but were significantly greater after lunch. Mean 24-hour and nocturnal serum glucose concentrations were similar, and both insulins were associated with < or = 7 minor and no major hypoglycemic events. CONCLUSIONS: Premeal injection of BIAsp 30 in a twice-daily regimen significantly reduced overall postprandial glucose excursions. This effect may be of importance when improvement in postprandial glucose control is desired.     

Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes

OBJECTIVE: The antibody responses to a novel rapid-acting insulin analog, insulin aspart (IAsp), and their potential clinical correlates were studied with a specifically developed method in 2,420 people with diabetes treated for up to 1 year with preprandial subcutaneous injections of IAsp. RESEARCH DESIGN AND METHODS: Circulating insulin antibodies were analyzed by radioimmunoassay with (125)I insulin or IAsp tracers and polyethylene glycol precipitation. Four multinational, open, parallel group studies were conducted in Europe and North America, with a total of 1,534 people with diabetes exposed to IAsp and 886 people exposed to human insulin (HI) as meal-related insulin for 6-12 months. RESULTS: Insulin antibodies specific to HI or IAsp were absent in a majority of patients throughout the 6- to 12-month study periods. A majority of the patients (64-68%) had antibodies cross-reacting between HI and IAsp when entering the studies, with baseline levels (means +/- SD of percent bound/total) of 16.6 +/- 16.3% in study 1 and 10.3 +/- 14.0% in study 4. In all four studies, cross-reactive antibodies increased in patients exposed to IAsp, with a maximum at 3 months, and thereafter there was a decline toward baseline levels at 9-12 months (levels at 3 and 12 months: 22.3 +/- 19.7 and 16.8 +/- 16.5% in study 1 and 21.5 +/- 21.9 and 16.9 +/- 17.4% in study 4). Antibody levels showed similar changes in people with type 1 and type 2 diabetes, and there was no consistent relationship between antibody formation and glycemic control or between antibody formation and safety in terms of adverse events. CONCLUSIONS: Treatment with IAsp is associated with an increase in cross-reactive insulin antibodies, with a subsequent fall toward baseline values, without any indication of clinical relevance because no effect on efficacy or safety could be identified.     

Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus

OBJECTIVE: The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen in patients with type 2 diabetes mellitus (DM). Also assessed was patients' preference for pen device--the NovoMix 30 FlexPen /NovoLog Mix 70/30 FlexPen (FlexPen) versus the Humalog Mix25 Pen/Humalog Mix75/25 Pen (Humalog Pen). METHODS: Patients with type 2 DM receiving current insulin treatment were randomized to a multinational, multicenter, open-label, 2-period, crossover comparison of BIAsp 30 and Mix25. Efficacy (by analyses of variance) and safety profiles were assessed after 12 weeks of treatment. Patients' preference for pen device was assessed by questionnaires. RESULTS: A total of 137 patients were randomized to treatment; 4 were withdrawn during the 2-week run-in treatment with biphasic human insulin 30. The mean (SD) characteristics of the remaining 133 patients (79 men, 54 women) were as follows: age, 62.3 (9.2) years; body mass index, 28.1 (3.9) kg/m(2); and glycosylated hemoglobin (HbA(1c)), 8.5% (1.1). Glycemic control was assessed by the measurement of HbA(1c) after 12 weeks of treatment. Treatment with BIAsp 30 was noninferior to treatment with Mix25 (upper limit of 90% CI for estimated difference [BIAsp 30 - Mix25] was <0.4%). Self-monitored blood glucose levels were comparable (P = NS). Adverse-event profiles were similar between treatments, as was the incidence of hypoglycemic episodes (0.69 episode/mo with BIAsp 30 and 0.62 episode/mo with Mix25, P = 0.292). For all device features assessed, the FlexPen consistently received higher scores (all P < 0.005). A total of 9.0% of patients experienced problems with the FlexPen, compared with 32.4% with the Humalog Pen (P < 0.001). Furthermore, 74.6% preferred to continue using the FlexPen, whereas 14.3% preferred the Humalog Pen (P < 0.001). CONCLUSIONS: In this study, glycemic control with BIAsp 30 and Mix25 was found to be comparable in these patients with type 2 DM. Safety profiles were similar for both regimens. Patients preferred and experienced fewer problems with the FlexPen than the Humalog Pen.     

门冬胰岛素30治疗2型糖尿病的疗效观察

目的比较门冬胰岛素30(诺和锐30特充)和预混人胰岛素(诺和灵30R)每日2次在开始胰岛素治疗的2型糖尿病(T2DM)患者的疗效和安全性。方法48例口服药物治疗血糖控制不佳的T2DM患者被随机分为诺和锐30特充治疗组和诺和灵30R治疗组,采用每日早、晚餐前两次皮下注射方案,观察两组患者5个时点血糖、低血糖事件及血糖达标时间、最后每日胰岛素用量、患者依从性差异。结果诺和锐30特充治疗组空腹及三餐后2 h、夜间血糖水平和诺和灵30R组相比差异无统计学意义(P>0.05);诺和锐30特充组低血糖、严重低血糖发生次数、每日胰岛素用量低于诺和灵30R组(P<0.05);诺和锐30特充组患者依从性高于诺和灵30R组(P<0.05)。结论诺和锐30特充治疗2型糖尿病和诺和灵30R控制血糖同样有效,但安全性和患者依从性较高。     

胰岛素泵与门冬胰岛素30治疗初诊2型糖尿病的疗效比较

目的探讨胰岛素泵强化疗法与胰岛素皮下注射强化疗法治疗初诊2型糖尿病的临床疗效。方法将确诊为2型糖尿病的68例初诊患者随机分为两组,分别为对照组(胰岛素皮下注射强化治疗组)34例和观察组(胰岛素泵强化治疗组)34例。观察两组患者治疗前、后2周血糖及达标时间、用药量、胰岛素分泌指数(HOMA-BE)、胰岛素抵抗指数(HOMA-IR)。结果两组患者治疗后的空腹血糖、餐后2 h血糖水平均较治疗前明显下降;治疗前后观察组与对照组空腹血糖、餐后2 h血糖水平差异均无统计学意义(P>0.05)。观察组胰岛素用量、血糖达标时间、低血糖次数明显低于对照组(P<0.05或P<0.01);两组患者治疗后HOMA-IR均较治疗前明显降低。结论胰岛素泵强化治疗初诊2型糖尿病临床疗效与门冬胰岛素30三针皮下注射治疗疗效相当,但胰岛素泵强化治疗可缩短血糖达标时间,减少胰岛素用量,降低低血糖发生率。     

Cost-effectiveness of biphasic insulin aspart versus insulin glargine in patients with type 2 diabetes in China

Background  

The OnceMix and INITIATE studies have indicated that biphasic insulin aspart 30 (BIAsp 30) is more effective than insulin glargine (IGlarg), in terms of glycohemoglobin reductions, in patients with type 2 diabetes initiating insulin therapy. The cost-effectiveness of BIAsp 30 versus IGlarg in the Chinese setting is estimated here.     

Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia

OBJECTIVE

Hypoglycemia causes recurrent morbidity in patients with type 2 diabetes. This study evaluated if exenatide twice daily (BID) was noninferior to premixed insulin aspart 70/30 BID (PIA) for glycemic control and associated with less hypoglycemia.

RESEARCH DESIGN AND METHODS

In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.

RESULTS

Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change −1.0 vs. −1.14%; difference [95% CI] 0.14 [−0.003 to 0.291]) and associated with a lower risk for hypoglycemia (8.0 vs. 20.5%, P < 0.05). LS mean weight decreased by 4.1 kg and increased by 1.0 kg with PIA (P < 0.001). A total of 39.2 vs. 20.8% of patients reached the composite end point of A1C <7.0%, no weight gain, and no hypoglycemia (P < 0.001; post hoc analysis).

CONCLUSIONS

In metformin-treated patients, exenatide BID was noninferior to PIA for glycemic control but superior for hypoglycemia and weight control.The well-known limitations of insulin therapy are weight gain and increased risk of hypoglycemia (1,2). Results of cardiovascular outcome trials (3,4) have triggered a discussion about the association between hypoglycemia and increased mortality (5). The American Diabetes Association defines the prevention of hypoglycemia as a critical component of diabetes management (6). This study was specifically designed to compare hypoglycemia with exenatide twice daily (BID) versus premixed insulin aspart 70/30 BID (PIA) (70% protamin crystallized, 30% soluble) at a noninferior level of glycemic control in type 2 diabetic patients on metformin treatment. An additional smaller patient cohort previously treated with metformin plus sulfonylurea or meglitinides was enrolled into an exploratory arm; data have been published separately (7).     

Efficacy, safety, and pump compatibility of insulin aspart used in continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes

OBJECTIVE: The purpose of this study was to compare the efficacy, safety and pump compatibility of insulin aspart (a rapid-acting insulin analog) and buffered regular human insulin in patients with type 1 diabetes undergoing continuous subcutaneous insulin infusion (CSII) therapy. RESEARCH DESIGN AND METHODS: This was a single-center randomized open-label study Patients received CSII therapy with insulin aspart (n = 19) or buffered regular human insulin (n = 10) for 7 weeks. Bolus doses of insulin aspart were administered immediately before meals and buffered regular human insulin 30 min before meals. RESULTS: Insulin aspart and buffered regular human insulin were both effective in controlling average daily blood glucose levels (8.2 +/- 1.9 and 8.5 +/- 2.1 mmol/l, respectively) (mean +/- SD) and maintaining serum fructosamine (343 +/- 25.7 and 336 +/- 27.4 micromol/l) and HbA1c (6.9 +/- 0.6 and 7.1 +/- 0.6%) levels. Possible obstructions and set leakages were infrequently reported in both groups. Similar numbers of patients experienced hypoglycemia (blood glucose <2.5 mmol/l): 14 (74%) insulin aspart patients versus 6 (60%) buffered regular human insulin patients. Patients receiving insulin aspart had fewer hypoglycemic events per patient (2.9) than those patients receiving buffered regular human insulin (6.2). There were no differences between the two insulins in the occurrence of hyperglycemic events (blood glucose >19 mmol/l) or in the number and type of adverse events. CONCLUSIONS: Insulin aspart and buffered regular human insulin were effective and well tolerated and provided similar pump compatibility when used in CSII therapy.