Lispro insulin treatment in comparison with regular human insulin in type 2 diabetic patients living in nursing homes

Lispro insulin has been demonstrated to be effective in reducing post-prandial blood glucose levels. Thirty Type 2 diabetic subjects (18 women and 12 men) living in nursing homes, aged 77 +/- 3 yr, mean systolic pressure 147 +/- 6 and diastolic 82 +/- 4 mmHg, body mass index 27.5 +/- 2 kg/m2, known diabetes duration 10.1+/- 0.7 yr, mean HbA1c 8.5 +/- 0.8%, fasting C-peptide 1.3 +/- 0.5 ng/ml, treated with intensive (4 insulin injections per day) therapy, mean insulin need 45 +/- 7 IU per day, with 2.0 +/- 0.6 hypoglycaemic (blood glucose level below 60 mg/dl) and 13 +/- 4 hyperglycaemic episodes (blood glucose level over 250 mg/dl) per wk, were studied. Their own informed consent or that provided by a family member was obtained before these patients took part in a therapy protocol divided into 3 four-mo periods; in the 1st and 3rd period regular insulin (75% of the total dose) was administered 30 min before each meal, in the second lispro insulin was administered immediately at the end of each meal, according to the carbohydrate quantity ingested with the meal. During the lispro treatment period there was a significant decrease of the mean daily blood glucose 166 +/- 12 regular vs 143 +/- 9 lispro; p<0.01, HbA1c 8.5 +/- 0.6 regular vs 7.6 +/- 0.5 % lispro; p<0.01, triglycerides 261 +/- 40 regular vs 218 +/- 20 mg/dl lispro; p<0.01, hypoglycaemic 2.1 +/- 0.2 regular vs 1.6 +/- 0.3 lispro; p<0.01 and hyperglicaemic 12 +/- 1 regular vs 8 +/- 0.3 lispro; p<0.01 episodes per wk. No statistical difference was recorded between the 1st and the 3rd treatment period. The lispro treatment produced a better metabolic control (mean blood glucose, HbA1c, triglycerides), better lifestyle (less hypo- and hyperglycaemic episodes), better nurse management (no waiting time before, but a more accurate calculation of the right dose administered immediately at the end of each meal). Lispro insulin seems to be a good therapeutic choice not only in Type 1, but also in the large population of elderly Type 2 diabetic patients.     

Treatment with the insulin analogue lispro in children and adolescents with type 1 diabetes mellitus: evaluation over a 3-year period

The aim of the present study was to evaluate the degree of metabolic control obtained with the use of the insulin analogue lispro compared to the previous regimen with classical regular insulin in children and adolescents with Type 1 diabetes mellitus. HbA1c, lipid metabolism, body mass index (BMI), frequency of severe hypoglycaemia, carbohydrate intake, total daily insulin requirements and its distribution during the day were analysed in 44 diabetics patients (57% males and 43% females) throughout a 3-yr period. The mean age of the patients at the beginning of the study was 15.6 +/- 2.7 yr with a mean duration of the disease of 8.01 +/- 3.4 yr. All data were evaluated for the year before the change of treatment, and 1 yr (44 patients), 2 yr (19 patients) and 3 yr (13 patients) after the change. HbA1c levels did not significantly change (6.6 +/- 1.1% with regular insulin, 6.32 +/- 1.05% in the 1st year with lispro, 6.6 +/- 1.1% in the 2nd yr with lispro, 6.33 +/- 0.9% in the 3rd yr with lispro). However, significant differences (p = 0.03) were found after 3 yr of treatment in those patients who changed to insulin lispro therapy due to a bad glycaemic control. The total daily insulin dose (U/kg/d) remained unchanged. The total short-acting/intermediate-acting insulin ratio significantly decreased (45.9 +/- 0.1% regular insulin; 37.2 +/- 0.1% 1st yr lispro (p < 0.001); 33.6 +/- 0.1% 2nd yr lispro (p < 0.05); 35.5 +/- 0.1% 3rd yr lispro (p < 0.05). BMI and lipid profile remained unchanged. The self-reported daily carbohydrate in take significantly decreased due to a reduction of snacks. Total number of episodes of severe hypoglycaemia did not change significantly. In conclusion insulin lispro treatment did not modify the daily insulin dose, but reduced the short-acting/intermediate acting insulin ratio. The metabolic control remained unchanged. The number of patients reporting severe hypoglycaemia was similar despite the treatment schedule. After this 3-yr duration trial all patients decided to continue the treatment with lispro insulin.     

Short acting insulin analogues for treating diabetic patients with CSII (continuous subcutaneous insulin infusion)

The use of insulin pump treatment (CSII: continuous subcutaneous insulin infusion) became widely accepted in the last couple of years. A growing body of experiences accumulated in paediatric practice because CSII is preferable for treating young patients with type 1 diabetes. Nevertheless, CSII can be used, if indicated, for treating type 2 diabetic patients as well. Recently, fast acting insulin analogues are exclusively used for CSII. At moment, clinical observations with insulin lispro and insulin aspart are available but experiences with glulisine are still limited. Although some inconsistencies could be observed in the literature, it is widely accepted, that higher reduction in HbA(1c) values could be achieved by CSII as compared to intensive conservative insulin treatment; this could be more pronounced in cases with high initial HbA(1c) values. CSII with short acting insulin analogues could lead to a higher reduction of HbA(1c) values than CSII with human regular insulin. Moreover, the decrease of hypoglycaemic events could be expected in some cases.     

Italian multicentre study of intensive therapy with insulin lispro in 1184 patients with Type 1 diabetes

Insulin lispro is absorbed more rapidly and has a shorter duration of action than regular human insulin. It improves glycaemic control but large-scale studies are required to identify regimens that optimise efficacy and safety with local dietary habits. This study involved 1184 Italian patients with Type 1 diabetes, randomised to insulin lispro (n=586) or regular human insulin (n=598) as pre-meal bolus for 3 months. Optimisation of basal NPH insulin was carried out in both groups. The number of administrations of NPH insulin was increased when using insulin lispro but, because basal and bolus insulins were mixed before meals, the total number of injections per day was unchanged. Compliance to administration time was significantly (p<0.001) greater with insulin lispro than with regular human insulin. Post-prandial blood glucose levels were lower with insulin lispro after breakfast (p<0.001), lunch (p<0.005) and dinner (p<0.001). The HbA1c level was decreased from baseline by both insulins, but the percent increase in patients with acceptable (<8%) HbA1c was greater with insulin lispro. While frequency of hypoglycaemia was decreased from baseline by both insulins, the proportion of episodes classified as severe was significantly increased from baseline with regular human insulin, but not with insulin lispro. Thus, compared with regular human insulin, improved glycaemic control was achieved with insulin lispro without an increase in severe hypoglyeaemia.     

The effect of combination treatment with acarbose and glibenclamide on postprandial glucose and insulin profiles: additive blood glucose lowering effect and decreased hypoglycaemia

This study compared the effects of acarbose plus glibenclamide combination therapy with acarbose or glibenclamide treatment alone on postprandial blood glucose, serum insulin and C-peptide levels, and the tendency to develop hypoglycaemia. A total of 84 patients with Type 2 diabetes (fasting blood glucose: 120-180 mg/dl; postprandial blood glucose: 140-240 mg/dl) was included in this two-centre, double-blind, double-dummy, placebo-controlled study. Patients were randomised to one of 4 treatment groups: acarbose (100 mg); glibenclamide (3.5 mg); acarbose plus glibenclamide; or placebo. Treatment was administered before a standard breakfast, and fasting (07.30 h, 08.00 h) and postprandial (09.00, 10.00, 11.00, 12.00 h) blood glucose, serum insulin and C-peptide levels were determined. Acarbose plus glibenclamide treatment significantly reduced the mean increase in postprandial blood glucose levels (23.7+/-17.3 mg/dl) compared with either acarbose (58.4+/-31.6 mg/dl), glibenclamide (56.9+/-42.8 mg/dl) or placebo (101.6+/-49.2 mg/dl) (p<0.05 for all). Serum insulin levels (mean AUC(7.30-12 h)) observed with acarbose plus glibenclamide combination therapy were significantly lower than those observed with glibenclamide monotherapy (243.5+/-161.1 vs 383.4+/-215.8 hr x microU/ml; p=0.02), and comparable with the values seen with placebo (226.0+/-166.6 hr x microU/ml), suggesting that acarbose modifies the insulin secretion induced by glibenclamide. Glibenclamide monotherapy resulted in a significantly higher rate of decrease in blood glucose level than with acarbose plus glibenclamide (71.8+/-29.9 vs 46.2+/-18.0 mg/dl x h(-1); p=0.0003), and blood glucose levels at 11.00 h were also markedly lower with glibenclamide (84.4+/-29 mg/dl) than acarbose plus glibenclamide (102.0+/-41 mg/dl), suggesting a reduced tendency for hypoglycaemic episodes with acarbose plus glibenclamide than with glibenclamide alone. In all, 6 (29%) hypoglycaemic episodes occurred with glibenclamide, 2 (10%) with acarbose plus glibenclamide and none with acarbose. Acarbose plus glibenclamide combination therapy results in an additive glucose lowering effect and reduced risk for hypoglycaemia. Acarbose modifies the insulin secretion induced by glibenclamide, which explains the lower risk of hypoglycaemia compared with glibenclamide monotherapy.     

Long acting insulin analogs: possibly more stable glucose regulation

A better diabetes regulation seems possible, with the aid of the recently available insulin analogs than with isophane insulin, for patients with diabetes mellitus type 1 or 2. The glycaemic regulation can be improved and/or the chances of hypoglycaemia can be reduced by reduced variability in the resorption of (insulin glargine) or by binding to the serum albumin (insulin detemir). With poor regulation it seems possible to bring about a substantial HbA1c reduction without an increase in hypoglycaemic incidents, and with reasonable to good regulation to achieve a reduction of the number of hypoglycaemias whilst HbA1c remains the same.     

胰岛素泵治疗重症高龄2型糖尿病患者临床分析

目的 比较胰岛素泵持续皮下输注胰岛素与多次皮下注射胰岛素对重症高龄2型糖尿病患者的疗效与安全性.方法 将37例在重症监护室（ICU）住院的重症高龄2型糖尿病患者按随机数字表法分为观察组（19例）和对照组（18例）,观察组用胰岛素泵持续皮下输注赖脯胰岛素,对照组用赖脯胰岛素三餐前及甘精胰岛素晚上睡前常规皮下注射,两组患者及家属均给予糖尿病教育、根据病情合适的糖尿病饮食,比较治疗前后两组患者的血糖变化、胰岛素用量、血糖控制达标时间、低血糖发生率及住院时间.结果 治疗后观察组空腹血糖为（7.2±1.2）mmo1/L,餐后2h血糖为（9.4±1.2） mmol/L,睡前血糖为（9.4±1.3） mmol/L,对照组分别为（8.5±3.0）、（10.0±2.4）、（10.2±2.4）mmol/L,治疗后两组患者空腹血糖、餐后2h血糖及睡前血糖均较治疗前显著下降,且两组治疗后比较差异有统计学意义（P＜0.05）.观察组患者血糖控制达标时间为（5.4±2.5）d,胰岛素用量为（43±9）U/d,而对照组分别为（12.8±3.8）d、（55±10）U/d,两组比较差异有统计学意义（P＜0.05）.观察组未见低血糖发生.结论 胰岛素泵持续皮下输注胰岛素与多次皮下注射胰岛素对重症高龄2型糖尿病均具有较好的疗效与安全性,且胰岛素泵持续皮下输注胰岛素更利于此类患者血糖控制及改善病情.     

甘精胰岛素联合口服药物治疗2型糖尿病的疗效及安全性分析

目的评价甘精胰岛素联合口服降糖药物（oral hypoglycemic drugs,OADs）治疗方案对使用预混胰岛素血糖控制欠佳的2型糖尿病患者的疗效及安全性。方法预混胰岛素30/70单独或联合使用OADs血糖控制不良的2型糖尿病患者50例,随机分为治疗组（停用预混胰岛素,改为皮下注射甘精胰岛素联合OADs）（n=30）和对照组（继续使用预混胰岛素早晚餐前皮下注射联合OADs）（n=20）,各组均依据血糖监测水平调整胰岛素及OADs用量。12周后对比两组患者空腹血糖（fasting blood glucose,FBG）、三餐后2 h血糖（2-hour postprandial blood glucose,2hPG）、糖化血红蛋白A1c（glycated hemoglobin A1c,HbA1c）、体重指数（body mass index,BMI）及试验期间低血糖发生次数。结果与治疗前相比,治疗组及对照组治疗后HbA1c、FBG、三餐2hPG均有所下降（P均〈0.01）;治疗组BMI无明显变化（P〉0.05）,对照组BMI较治疗前增加（P〈0.01）。与对照组相比,治疗组治疗后FBG、午餐2hPG及HbA1c均低于对照组（P均〈0.01）;治疗组治疗后BMI低于对照组（P〈0.01）;试验期间治疗组低血糖发生次数低于对照组（P〈0.01）。结论预混胰岛素血糖控制欠佳的2型糖尿病患者,改为甘精胰岛素联合OADs治疗,可使FBG和HbA1c显著改善,不增加体重,简便易行,且降低了低血糖风险。     

Comparison of 70/30 biphasic insulin with glargine/lispro regimen in non-critically ill diabetic patients on continuous enteral nutrition therapy

Despite significant advances in inpatient diabetes management, it is still a challenge to choose the safest and most efficacious subcutaneous insulin regimen for diabetic patients on continuous enteral nutrition (EN) therapy. The authors conducted a retrospective analysis of glycemic control in 22 non-critically ill diabetic patients, receiving at least 3 days of continuous EN. Patients received different insulin regimens while on continuous EN, including a basal/bolus glargine/lispro regimen (group 1, n = 8), 70/30 biphasic insulin twice daily (group 2, n = 8), and 70/30 biphasic insulin 3 times a day (group 3, n = 6). The glucose data from 72 hours from the initiation of EN were analyzed (12 point-of-contact glucose measurements per patient). Overall, the degree of control was comparable in all groups, with target range maintained more consistently in group 3 (70/30 insulin administered 3 times daily). In this group, 69% of values were in the target range (140-180 mg/dL) as compared with 24% in glargine/lispro group and 22% in the 70/30 insulin bid group. Eight hypoglycemic episodes occurred among the 3 groups: 5 episodes in group 1 (5.4%), 2 episodes in group 2 (2.1%), and 1 episode in group 3 (1.4%) (P = .05, groups 2 and 3 vs group 1). Administration of 70/30 biphasic insulin 3 times daily is a safe therapeutic regimen in diabetic patients on continuous EN as it maintains glycemia in the target range and might produce fewer episodes of hypoglycemia.     

A method to predict the metabolic effects of changes in insulin treatment in subgroups of a large population based patient cohort

This case-control study was designed to analyse predictors of the effects on HbA1c levels in 4001 type 1 and type 2 diabetic patients after changing their insulin treatment. Patients from 15 outpatient diabetic clinics were treated with basal insulin and multiple injections of short-acting insulin. The effects on HbA1c of changing from NPH insulin to insulin glargine as basal insulin were studied, compared to patients continuing with NPH insulin. The following possible predictors were examined with multiple regression analysis: age, sex, type and duration of diabetes, smoking, metformin use, insulin requirement, number of basal doses per day, BMI and HbA1c at baseline. The difference between the two regression functions yielded the effect of switching treatment to insulin glargine compared to continuing with NPH insulin. Male gender, low BMI and high baseline HbA1c levels were significant predictors for a greater decrease in HbA1c when changing to insulin glargine. For example, for men with a BMI of 25 and an HbA1c of 8.0%, there was a calculated mean benefit in HbA1c of 0.26 percentage points by changing to insulin glargine, whereas women with a BMI 30 had no benefit of such a change. Thus, changing to insulin glargine had best effect in male patients with low BMI. This is one of the first studies designed to find responders to insulin treatment. Analyses of predictors may prove useful in order to tailor insulin treatment in diabetic patients in clinical practice. The clinical effects need to be confirmed in other studies and randomised controlled trials.     

维格列汀联合甘精胰岛素治疗2型糖尿病的疗效及安全性分析

目的观察维格列汀联合甘精胰岛素治疗2型糖尿病的临床疗效及安全性。方法选取2016年1月~5月确诊2型糖尿病并需甘精胰岛素治疗的患者50例,随机分为甘精胰岛素+维格列汀组(甘精胰岛素10~25 U/d,维格列汀50 mg,2次/d)和甘精胰岛素+阿卡波糖组(甘精胰岛素10~25 U/d,阿卡波糖100 mg,3次/d),每组25例。治疗6个月,根据血糖情况调整剂量。比较两组治疗前及治疗6个月后胰岛素用量、血糖、糖化血红蛋白(Hb A1c)等指标的变化。结果治疗6个月后,两组餐后2 h血糖(2 h PG)、Hb A1c较治疗前有所下降(P0.05),甘精胰岛素+维格列汀组空腹血糖(FPG)下降更明显、胰岛素用量减少(P0.05);体质量指数(BMI)及低血糖发生次数两组间差异无统计学意义(P0.05)。结论维格列汀联合基础胰岛素治疗2型糖尿病更有利于患者空腹血糖、糖化血红蛋白的控制,同时可减少胰岛素用量,降低低血糖发生率。     

那格列奈联合甘精胰岛素治疗2型糖尿病患者的疗效观察

目的了解那格列奈联合甘精胰岛素治疗2型糖尿病患者的疗效。方法采取随机、对照的办法选取初发2型糖尿病患者50例,给予甘精胰岛素每天1次皮下注射,调整剂量使空腹血糖控制于5.0~8.0mmol/L,同时联合应用那格列奈,调整剂量使餐后2h血糖控制于8.0~10.0mmol/L,治疗2个月,观察疗效。结果 FPG,2hPG,HbA1c均明显下降(P﹤0.01),胰岛素1相分泌明显改善。结论那格列奈联合甘精胰岛素对初发2型糖尿病患者血糖有较好疗效,能明显改善胰岛素的I相分泌。     

Hyperhomocysteinemia in poorly controlled type 2 diabetes patients

Elevated blood level of homocysteine is strongly related to an increased risk for atherosclerosis and cardiovascular disease. The role of homocysteine in Type 2 diabetes vascular complications remains unclear. Our objective was to investigate homocysteine levels in poorly controlled Type 2 diabetic patients, who are at increased risk of vascular complications development. Forty-four Type 2 diabetic patients with no symptoms of any cardiovascular disease were divided into 2 groups: 26 patients with poor metabolic control treated with oral agents (aged 66.8 +/- 5.4 yr, diabetes duration 11.9 +/- 4.1 yr, fasting plasma glucose 13.9 +/- 4.6 mmol/l, HbA1C 9.8 +/- 1.6%), 18 well-matched diabetic patients well-controlled with oral agents (aged 65.8 +/- 4.7 yr, diabetes duration 10.9 +/- 4.2 yr, fasting plasma glucose 7.3 +/- 2.4 mmol/l, HbA1c 6.6 +/- 0.7%). The controls were 12 healthy subjects. Fasting total plasma homocysteine and plasma insulin concentrations were measured. Plasma total homocysteine concentrations were significantly higher in poorly controlled than in well-controlled diabetic patients and controls (17.1 +/- 4.5 vs 8.2 +/- 3.9 and 6.5 +/- 4.9 micromol/l respectively, p < 0.001). Insulinemia showed an inverse correlation with homocysteine levels (8.3 +/- 5.2 vs 14.6 +/- 5.2 and 9.3 +/- 6.1 microlU/ml, p < 0.001; r = -0.32, p < 0.05). HbA1c values correlated positively with homocysteine concentrations in poorly controlled subjects (r = 0.41; p < 0.05). In conclusion, chronic poor metabolic control of Type 2 diabetes is characterized by elevation of plasma homocysteine concentration, which also inversely correlates with endogenous insulin levels. These results may add to the understanding of the increased frequency and mechanisms of vascular damage in diabetes mellitus.     

New methods in insulin treatment

The primary aim of insulin therapy is to replace endogenous insulin secretion in patients with type 1 or type 2 diabetes between meals and overnight as well as postprandially. The most frequently used insulin for basal therapy is the intermediate-acting neutral protamin Hagedorn (NPH) insulin, although it does not correspond to a physiological profile. Insulin glargine is a new extended-action recombinant insulin analog, which is absorbed slowly into the bloodstream, reaching peak action in about 4 h and maintaining this concentration profil for 24-30 h. Some studies demonstrated that insulin glargine reduces the incidence of hypoglycemia and is at least as effective as NPH insulin given once or twice daily. It is equally effective administered before breakfast, dinner or at bedtime. Similar absorption rates were recorded after subcutaneous injection in differents part of body. The continuous subcutaneous insulin infusion utilizing an external insulin infusion pump (CSII) is one approach to intensive insulin therapy. Some studies indicate that pump therapy is associated with improved glycemic control compared with traditional insulin therapies and with significant decreases in frequency of both mild and severe hypoglycemic episodes. The author summarizes the indication, the effect and side effects of pump therapy.     

The Association between Treatment Modality,Lipid Profile,Metabolic Control in Children with Type 1 Diabetes and Celiac Disease—Data from the International Sweet Registry

Background and Aims: A higher frequency of dyslipidemia is reported in children with type 1 diabetes (T1D) and celiac disease (CD). Recently, continuous subcutaneous insulin infusion (CSII) has been associated with better lipid profiles in patients with T1D. The aim of this study was to investigate the association between treatment modality and lipid profile, metabolic control, and body mass index (BMI)-SDS in children with both T1D and CD. Methods: Cross-sectional study in children registered in the international SWEET database in November 2020. Inclusion criteria were children (2–18 years) with T1D and CD with available data on treatment modality (CSII and injections therapy, IT), triglyceride, total cholesterol, HDL, LDL, dyslipidemia, HbA1c, and BMI-SDS. Overweight/obesity was defined as > +1 BMI-SDS for age. Data were analyzed by linear and logistical regression models with adjustment for age, gender, and diabetes duration. Results: In total 1009 children with T1D and CD (female 54%, CSII 54%, age 13.9 years ±3.6, diabetes duration 7.2 years ±4.1, HbA1c 7.9% ±1.4) were included. Significant differences between children treated with CSII vs. IT were respectively found; HDL 60.0 mg/dL vs. 57.8 mg/dL, LDL 89.4 mg/dL vs. 94.2 mg/dL, HbA1c 7.7 vs. 8.1%, BMI-SDS 0.4 vs. 0.6, overweight and obesity 17% vs. 26% (all p < 0.05). Conclusions: CSII is associated with higher HDL and lower LDL, HbA1c, BMI-SDS, and percentage of overweight and obesity compared with IT in this study. Further prospective studies are required to determine whether CSII improves lipid profile, metabolic control and normalize body weight in children with both T1D and CD.     

Glycosylated haemoglobin and serum insulin antibodies in type I diabetes

Type 1 diabetics receiving once (Group 1, n = 72) and twice (Group 2, n = 48) daily subcutaneous injections of conventional beef insulin were compared, on a cross-sectional basis, in respect of insulin antibody binding by serum and total glycosylated haemoglobin (HbA1). Patients in Group 1 had higher insulin antibody binding (25.2 +/- 15.8% vs 17.0 +/- 13.9%; p less than 0.01) and higher HbA1 levels (12.5 +/- 2.0% vs 11.0 +/- 1.8%; p less than 0.001) than patients in Group 2. An inverse correlation (tau = -0.28, p less than 0.01) was observed between HbA1 and insulin antibody binding in C-peptide non-secretors of Group 1 but not in Group 1 C-peptide secretors, nor in C-peptide secretors and/or non-secretors of Group 2. It is suggested that in Type 1 diabetics who receive a single daily insulin injection and who have no endogenous insulin secretion, insulin antibodies may aid glycaemic control by prolonging insulin action.     

The combination metformin/glyburide exerts its hypoglycemic effect mainly by increasing insulin secretion: a controlled, randomized, double-blind, crossover study

The aim of the present study was to describe the mechanism by which the combination glyburide/metformin exerts its additive hypoglycemic effects. This is a double-blind, randomized and crossover clinical trial. Patients (n = 20) were included in a run-in period of 8 weeks in which an isocaloric diet was prescribed. If they did not achieve the treatment goals (n = 15), they received glyburide, metformin or combined treatment for 10 weeks each using three possible sequences. The dosage was adjusted to reach fasting plasma glucose (FPG) < 7.7 mmol/l. Treatment periods were separated by a 6-12 week washout period. At the beginning and the end of every treatment, insulin sensitivity and insulin secretion were measured by means of a minimal model and an oral glucose tolerance test. All treatment periods were completed by 12 cases. The glycemic goal was reached in 1 case during metformin, in 5 during glyburide and in 10 during the combination. The greatest reduction in HbA1c was achieved during the combination (HbA1c 11 +/- 1.6 vs 9.8 +/- 1.9 vs 9.0 +/- 2.1% for metformin, glyburide and the combination, p < 0.001). Increased insulin secretion was the explanation for the additive effects of the combination (percentual change in acute insulin response during the minimal model = 5.8 vs 51.5 vs 88.2% for metformin, glyburide and the combination, p < 0.05). No change in insulin sensitivity resulted from the treatments. In conclusion, the additive hypoglycemic effects of the combination glyburide/metformin was caused by increased insulin secretion.     

胰岛素泵在2型糖尿病并肺部感染的应用效果观察

目的观察应用胰岛素泵进行连续皮下胰岛素输注(CSII)治疗2型糖尿病并肺部感染患者强化血糖控制的疗效。方法将住院的2型糖尿病并肺部感染患者83例随机分为皮下胰岛素泵治疗组(CSII组,42例)和多次皮下注射治疗组(MSII组,41例),观察血糖、血糖下降至正常的时间、肺部感染控制时间、费用及低血糖发生率。结果两组患者的血糖治疗后均明显下降,达目标血糖值的时间、肺部感染控制时间、胰岛素用量、低血糖发生率CSII组较MSII组明显减少(P<0.05);CSII组治疗后糖化血红蛋白、总胆固醇、C-反应蛋白明显降低,而空腹C肽、高密度脂蛋白-胆固醇明显升高(P<0.05)。而MSII组治疗前后上述指标的差异无统计学意义(P>0.05)。结论CSII能更好地控制血糖,纠正代谢紊乱,减少费用和住院天数,并能减少低血糖发生,是较为理想的方法。     

甘精胰岛素联合瑞格列奈对2型糖尿病患者血糖控制及低血糖发生率的影响

目的 探讨甘精胰岛素联合瑞格列奈对0型糖尿病患者血糖控制以及低血糖发生率的影响.方法 选取0型糖尿病患者70例,随机分为两组各35例.对照组予以甘精胰岛素治疗,实验组予以甘精胰岛素联合瑞格列奈治疗,两组均治疗3个月.比较两组的血糖控制及低血糖发生率.结果 治疗后,两组的FPG、0hPG与HbA1c水平均显著低于治疗前,...     

Cost effectiveness of insulin glargine plus oral antidiabetes drugs compared with premixed insulin alone in patients with type 2 diabetes mellitus in Canada

Background

Several treatment options are available for patients with type 2 diabetes mellitus who are making the transition from oral antidiabetes drugs (OADs) to insulin. Two options currently recommended by the Canadian Diabetes Association for initiating insulin therapy in patients with type 2 diabetes who are no longer responsive to OADs alone are insulin glargine plus OADs, and premixed insulin therapy only. Because of differences in efficacy, adverse events (such as hypoglycaemia) and acquisition costs, these two treatment options may lead to different long-term clinical and economic outcomes.

Objective

To determine the cost effectiveness of insulin glargine plus OADs compared with premixed insulin without OADs in insulin-naive patients with type 2 diabetes in Canada.

Methods

Using treatment effects taken from a published clinical trial, the validated IMS-CORE Diabetes Model was used to simulate the long-term cost effectiveness of insulin glargine with OADs, versus premixed insulin. Input treatment effects for the two therapeutic approaches were based on changes in glycosylated haemoglobin A_1c (HbA_1c) at clinical trial endpoint, and hypoglycaemia rates. The analysis was conducted from the perspective of the Canadian Provincial payer. Direct treatment and complication costs were obtained from published sources (primarily from Ontario) and reported in $Can, year 2008 values. All base-case costs and outcomes were discounted at 5% per year. Sensitivity analyses were conducted around key parameters and assumptions used in the study. Outcomes included direct medical costs associated with both treatment and diabetes-related complications. Cost-effectiveness outcomes included total average lifetime (35 years) costs, life expectancy (LE), QALYs and incremental cost-effectiveness ratios (ICERs).

Results

Base-case analyses showed that, compared with premixed insulin only, insulin glargine in combination with OADs was associated with a 0.051-year increase in LE and a 0.043 increase in QALYs. Insulin glargine plus OADs showed a very slight increase in total direct costs ($Can343 ± 2572), resulting in ICERs of $Can6750 per life-year gained (LYG) and $Can7923 per QALY gained. However, considerable uncertainty around the ICERs was demonstrated by insulin glargine having a 50% probability of being cost effective at a willingness-to-pay threshold of $Can10 000 per QALY, and a 54% probability at a $Can20 000 threshold. Base-case results were most sensitive to assumed disutilities for hypoglycaemic events, to the assumed effect of insulin glargine plus OADs on HbA_1c, and to its assumed acquisition costs.

Conclusions

These findings should be interpreted within the context of a large degree of uncertainty and of several study limitations that include a single clinical trial as the source for primary treatment assumptions and a single province as the source for most cost inputs. Under current study assumptions and limitations, insulin glargine plus OADs was projected to be a cost-effective option, compared with premixed insulin only, for the treatment of insulin-naive patients with type 2 diabetes unresponsive to OADs. Additional work is needed to examine the generalizability of the findings to individual jurisdictions of the Canadian healthcare system.