The effects of insulin glargine treatment and an educational programme on glycaemic control in type 2 diabetes patients in clinical practice

ABSTRACT

Objective: This retrospective analysis was performed to establish the effect of initiating insulin glargine (LANTUS; sanofi-aventis, Paris, France), a once-daily basal insulin analogue, in combination with an educational programme on glycaemic control and body weight in sub-optimally controlled patients with Type 2 diabetes in clinical practice.

Research design and methods: We undertook a retrospective review of the medical records of 46 patients (mean age 61.5 ± 8.6 years) with Type 2 diabetes. These patients had previously been treated with oral antidiabetic agents (OADs; n = 18) or insulin only (n = 28) and had then received insulin glargine in combination with OADs or prandial insulin, for 30 months. Records of metabolic control and body weight data were analysed at 9 and 30 months. Patients had taken part in a diabetes educational programme before initiation of insulin glargine and received continued physician consultations throughout.

Results: Following initiation of insulin glargine, patients showed a significant decrease in HbA_1c from 8.14 ± 1.7% to 7.18 ± 0.9% at 30 months (?p < 0.001). When the results were analysed by pre-treatment, patients pre-treated with OADs showed a reduction in HbA_1c of 2.3% at 30 months (?p < 0.001), while patients pre-treated with insulin only showed a decrease in HbA_1c of 0.4% (?p < 0.005). There was no significant change in body weight. No unexpected adverse events or episodes of severe hypoglycaemia (blood glucose < 40?mg/dL [< 2.2?mmol/L]) occurred.

Conclusions: Insulin glargine in combination with educational support and close clinical supervision significantly improved metabolic control without significant weight change in patients with Type 2 diabetes in clinical practice over 30 months. Additional studies are required to establish if similar results can be obtained in a larger cohort of patients.     

Long-term efficacy of insulin glargine therapy with an educational programme in type 1 diabetes patients in clinical practice

ABSTRACT

Objective: To investigate the effect of initiating insulin glargine (glargine: LANTUS*), a once-daily basal insulin analogue, plus an educational programme, on glycaemic control and body weight in patients with type 1 diabetes in clinical practice.

Research design and methods: A retrospective analysis of the medical records of 65 patients (mean age: 40.7 ± 13.3 years) with type 1 diabetes was performed. Patients had previously been treated with NPH insulin (NPH; n = 54) or NPH insulin + lente insulin (NPH + lente; n = 11) and then received glargine once daily (bedtime), plus short-acting prandial insulin, for 30 months. Before initiation of glargine, patients participated in a diabetes educational programme and then received physician consultations throughout the study. Metabolic control, body weight and severe hypoglycaemia data were analysed at 9 and 30 months.

Results: Following initiation of glargine, patients showed a decrease in HbA_1c from 7.29 ± 1.1% to 7.06 ± 1.0%; p < 0.01 at 30 months. When the results were analysed by pre-treatment, both NPH-pre-treated and NPH+lente-pre-treated patients showed a significant reduction in HbA_1c of 0.14% and 0.82%, respectively, at 30 months (7.27 ± 1.2% to 7.13 ± 1.1% and 7.42 ± 1.2 to 6.60 ± 0.3%, respectively; p < 0.01). No change in body weight was observed in the overall group. No episodes of severe hypoglycaemia (blood glucose <?40?mg/dL [<?2.2?mmol/L] occurred.

Conclusions: In this retrospective study of medical records, patients with type 1 diabetes treated with insulin glargine over 30 months in combination with educational support and close clinical supervision decreased their HbA_1c levels without weight gain versus previous treatment with NPH insulin or insulin lente. Further studies in a larger cohort of patients would help to confirm these results.     

甘精胰岛素与西格列汀联用治疗老年2型糖尿病临床观察

目的探讨甘精胰岛素联用西格列汀治疗高龄2型糖尿病的疗效及安全性。方法将78例60岁以上的2型糖尿病患者随机分成甘精胰岛素联用西格列汀组(G组)40例和生物合成预混30/70人胰岛素组(N组)38例,根据血糖情况调整用药剂量,治疗12周后比较两组的空腹血糖、餐后2 h血糖、糖化血红蛋白(HbA1c)、低血糖发生率及体重指数(BMI)。结果 G组在空腹2 h血糖和低血糖发生率方面均低于N组,两组比较差异有统计学意义(P<0.05);在餐后血糖、HbA1c和BMI方面两组比较差异无统计学意义(P>0.05)。结论甘精胰岛素与西格列汀联用对老年2型糖尿病患者是一种安全、有效且方便的治疗方案,低血糖发生率低,尤其是对认知力较差、活动不方便、视力差或合并多种慢性病的高龄2型糖尿病患者尤为适用。     

Deleterious outcomes after abrupt transition from insulin glargine to insulin detemir in patients with type 1 diabetes mellitus

BACKGROUND AND OBJECTIVE: Iowa Care (Iowa Medicaid), USA, switched insulin glargine to insulin detemir in subjects with diabetes mellitus without the approval of healthcare providers. This study set out to examine the impact of transition on parameters of diabetes management in type 1 diabetes. METHODS: This was a retrospective review of the records of subjects with type 1 diabetes up to August 2007 in whom transition occurred. Subjects completing 6 months of insulin detemir therapy were included. Twenty-four subjects switching from insulin glargine to insuline detemir (group 1) fulfilled the duration with insulin detemir. Glycaemic control (glycosylated haemoglobin [HbA1c]), bodyweight, daily insulin dose (units), total and insulin glargine or insulin detemir and rapid-acting insulin aspart and hypoglycaemic events during the last 4 weeks, pre-switch and again at 6 months post-switch were assessed. Records of 21 age-matched subjects and continuing insulin glargine for 6 months (group 2) were examined. Subjects switched from insulin glargine to insulin detemir in the same daily dose. The daily doses of insulin detemir and aspart in group 1 were adjusted by telephone weekly based on blood glucose monitoring until stabilization occurred. Subjects were followed up in the outpatient clinic every 3 months. RESULTS: Subjects in group 1 changed to insulin detemir twice a day because of a significant rise in hypoglycaemia with the daily dose used once a day. Glycaemic control remained stable on continuing insulin glargine; HbA1c 7.6+/-0.3 to 7.8+/-0.3%, while it worsened on switching to insulin detemir; HbA1c 7.9+/-0.6 to 8.8+/-0.8 despite a higher daily dose; insulin detemir 46+/-9 U/day versus pre-switch insulin glargine 36+/-8 U/day and group 2 insulin glargine 35+/-6 U/day; and greater total insulin dose: 80+/-12 U/day versus 68+/-10 pre-switch and group 2 insulin glargine 62+/-10 U/day (p<0.05 for all comparisons). Bodyweight and hypoglycaemic events were not significantly different pre- and post-switch. CONCLUSION: Switching to insulin detemir from glargine is likely to result in lapse of glycaemic control despite a higher daily insulin dose, increased number of injections and need for frequent evaluations.     

Fixed-ratio combination therapy with GLP-1 receptor agonist liraglutide and insulin degludec in people with type 2 diabetes

Introduction: A fixed combination of basal insulin degludec and glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide (IDegLira; 50 units degludec/1.8 mg liraglutide) has been developed as a once daily injection for the treatment of type 2 diabetes (T2D). In the phase 3a trial programme ‘Dual action of liraglutide and insulin degludec in type 2 diabetes’ (DUAL?), five trials of 26 weeks duration and one trial of 32 weeks duration have evaluated the efficacy and safety of IDegLira compared with administration of insulin degludec, insulin glargine, liraglutide alone or placebo.

Areas covered: Combination therapy with IDegLira reduces HbA1c more than monotherapy with a GLP-1RA (liraglutide) or insulin (degludec or glargine). Combination therapy leads also to weight loss, or a stable body weight, with no increase in hypoglycaemia. Rates of adverse events did not differ between treatment groups; however, gastrointestinal side effects were fewer with IDegLira compared with liraglutide treatment alone. A limitation of the DUAL? development programme is that patients receiving basal insulin doses in excess of 50 units were excluded from the studies.

Expert commentary: In conclusion, IDegLira combines the clinical advantages of basal insulin and GLP-1RA treatment, and is a treatment strategy that could improve the management of patients with T2D.     

口服降糖药血糖控制不佳的2型糖尿病加用地特胰岛素或甘精胰岛素的疗效比较

目的评估口服降糖药血糖控制欠佳的2型糖尿病患者联合地特胰岛素或甘精胰岛素治疗的有效性和安全性。方法 90例血糖控制欠佳的2型糖尿病患者随机分为地特胰岛素组和甘精胰岛素组。在16周治疗期调整胰岛素剂量至空腹血糖≤6.0 mmol/L。记录治疗前后空腹血糖（FPG）、糖化血红蛋白（HbA1c）、低血糖事件及体重。结果治疗16周,两组FPG及HbA1c均较基线下降,两组间差异无统计学意义。两组低血糖发生率均为6.6%,但地特胰岛素组的体重增加明显低于甘精胰岛素组（P〈0.05）。结论口服降糖药血糖控制欠佳的2型糖尿病患者联合地特胰岛素或甘精胰岛素均能有效控制血糖,并且有较低的低血糖风险。相比甘精胰岛素,地特胰岛素在减少体重增加方面更有优势。     

A prospective study to optimize insulin treatment by switching to insulin glargine in type 2 diabetic patients previously uncontrolled on premixed insulin: the optimization study

Abstract

Objective:

To evaluate the efficacy, safety and treatment satisfaction of insulin glargine plus oral antidiabetic drugs (OADs) in Chinese individuals with Type 2 diabetes inadequately controlled with premixed insulin plus OADs.     

格列美脲联合甘精胰岛素治疗2型糖尿病的疗效

目的:观察磺脲类药物继发性失效者联合甘精胰岛素治疗2型糖尿病的疗效及胰岛β细胞功能变化。方法:对磺脲类药物继发性失效患者改用格列美脲,睡前分别注射甘精胰岛素(甘精组,24例)、优泌林30R(优泌林组,30例),12周后比较两组血糖、糖化血红蛋白(HbA1c)以及血清C肽的变化。结果:两组血糖和HbA1c均有下降(P<0.01或P<0.05),治疗后C肽升高(P<0.05)。结论:联合甘精胰岛素治疗2型糖尿病有较好疗效,并有可能改善β细胞的功能。     

艾塞那肽与甘精胰岛素治疗血糖控制不佳的2型糖尿病的临床对照研究

目的探讨艾塞那肽与甘精胰岛素治疗血糖控制不佳的2型糖尿病(T2DM)的临床疗效、用药依从性以及安全性。方法选择我院收治的血糖控制不佳的2型糖尿病患者为研究对象,随机分为艾塞那肽组和甘精胰岛素组,在原有口服降糖药物治疗基础上,分别给予艾塞那肽和甘精胰岛素皮下注射以控制血糖,观察并记录两组患者治疗前后的血糖控制情况、糖化血红蛋白(HbA1c)变化、体重变化情况,同时对两组患者用药的依从性及用药期间的不良反应发生情况进行对比分析。结果治疗26周后,两组患者临床症状及血糖均较治疗前有明显改善,甘精胰岛素组显效率略高于艾塞那肽组,但差异无统计学意义(P>0.05)。两组患者FBG、2hPG、HbA1c水平均较治疗前有明显改善(P<0.05或P<0.01);甘精胰岛素组FBG水平较艾塞那肽组改善更为明显(P<0.05);艾塞那肽组2hPG、HbA1c水平较甘精胰岛素组改善更为显著(P<0.05);艾塞那肽组HbA1c<7%的达标率明显高于甘精胰岛素组(P<0.05),而HbA1c<6.5%的达标率高于甘精胰岛素组,但差异无统计学意义(P>0.05)。艾塞那肽组患者体重呈进行性降低,甘精胰岛素组患者体重呈进行性增加,但与治疗前比较差异均无统计学意义(P>0.05)。艾塞那肽组患者低血糖发生率低于甘精胰岛素组,恶心、腹泻发生率均高于甘精胰岛素组,但差异均无统计学意义(P>0.05)。艾塞那肽组患者用药依从性明显优于甘精胰岛素组,差异有统计学意义(P<0.05)。结论艾塞那肽与甘精胰岛素均能有效控制2型糖尿病患者血糖,降低糖化血红蛋白水平。虽然治疗期间艾塞那肽恶心、腹泻发生率较高,但往往症状较轻,低血糖发生率较低,能在一定程度上减轻体重压力,且能更好地降低HbA1c水平,同时具有良好的用药依从性,值得临床推广应用,但艾塞那肽的远期疗效仍需进一步研究证实。     

甘精胰岛素联合口服降糖药治疗2型糖尿病疗效观察

目的观察甘精胰岛素(来得时)联合口服降糖药治疗2型糖尿病的临床疗效。方法对47例单用口服降糖药效果欠佳的2型糖尿病患者睡前(22时)加用甘精胰岛素分别测定治疗3个月前后的空腹血糖(FPG)、餐后2h血糖(2hPG)、糖化血红蛋白(HbA1c)、空腹C肽、餐后2hC肽,血脂、体重。结果加用甘精胰岛素治疗3个月后,患者的FPG、2hPG、HbA1c较治疗前明显下降(P<0.01),餐后2hC肽较治疗前明显升高,其差异有统计学意义(P<0.01),而对血脂、体重指数影响不大。结论对单用口服药效果不佳的2型糖尿病,加用甘精胰岛素治疗效果显著。     

Insulin glargine: the first clinically useful extended-action insulin analogue

Insulin glargine is a new extended-action insulin analogue, created by recombinant DNA modification of human insulin. Extension of the C-terminal of the B-chain with two arginine residues and the substitution of glycine for asparagine at position A-21 increases the isoelectric point, resulting in precipitation of the insulin at the injection site and a protracted absorption. Pharmacodynamic studies have demonstrated a prolonged metabolic profile without a pronounced peak and with a duration of action of 20 - 30 h. In clinical studies in people with Type 1 and Type 2 diabetes, insulin glargine has demonstrated improved pre-breakfast blood glucose control and a reduction in the frequency of hypoglycaemia, especially nocturnal hypoglycaemia, in comparison with neutral protamine hagedorn (NPH) insulin. In addition, 24h glycaemic control in Type 2 diabetes and treatment satisfaction may also be improved. However, whilst appearing achievable, insulin glargine has not yet demonstrated the ability to improve HbA(1c), though this may relate to inexperience in the use of the new compound. In order to fully exploit its metabolic advantages, it appears vital that the dose of insulin glargine should be titrated to achieve aggressive pre-breakfast blood glucose targets beyond those achievable with NPH in the absence of nocturnal hypoglycaemia. Insulin glargine appears to be a promising new addition to the insulin family and with increased experience in its use, especially in combination with rapid-acting insulin analogues, its full benefits may be realised. The use of insulin glargine with a rapid-acting insulin analogue brings us the closest we have ever been to providing the physiological insulin replacement that has long been awaited.     

Effect of switching medically vulnerable patients with uncontrolled diabetes from isophane insulin human to insulin glargine.

PURPOSE: The purpose of this observational study was to determine if switching from isophane insulin human (NPH) to insulin glargine would improve glycemic control in a medically vulnerable population with uncontrolled diabetes. METHODS: A retrospective cohort review of patients' medical records was performed that recorded events occurring between January 1, 2001, and December 31, 2003. The cohort consisted of patients with diabetes in an adult medicine clinic at a county hospital. Patients were included if they were receiving NPH insulin for a minimum of six months and subsequently switched to insulin glargine for a minimum of six months. RESULTS: The study included 43 patients. There was no significant difference in mean glycosylated hemoglobin (HbA(1c)) between NPH insulin (9.6%) and insulin glargine (9.7%) regimens (p = 0.78, 95% confidence interval, -0.62%, 0.82%). Neither was there a significant difference in the frequency or severity of hypoglycemic episodes between the two treatments. Patients experienced significantly fewer diabetes-associated visits over six months while on insulin glargine. Refill frequency did not differ significantly when patients were receiving NPH insulin versus insulin glargine. When analyzing patient characteristics, those of Hispanic ethnicity experienced HbA(1c) values significantly higher than white patients. Several characteristics were associated with refill frequency. CONCLUSION: The results of our study indicate that both NPH- and glargine-based basal insulin regimens result in similar levels of glycemic control in a medically vulnerable population with diabetes, without significant differences in the number or severity of hypoglycemic episodes or in refill frequency.     

The effects of orlistat in patients with diabetes: improvement in glycaemic control and weight loss

OBJECTIVE: In addition to direct weight reduction, there may be other benefits of obesity treatment including improved insulin sensitivity. The purpose of this study was to characterise concomitant diabetes drug use and the related costs in patients with diabetes treated with orlistat (Xenical) in the first 6 months of treatment. METHODS: One hundred overweight patients with diabetes and a body mass index (BMI) > or = 28 kg/m2 were enrolled in a structured UK hospital-based weight management clinic and treated with orlistat plus behavioural interventions. Among other measures, weight, glucose control (HbA1c) and drug treatment were recorded. Subjects were followed-up for a maximum of 24 months at intervals of 1-3 months, with a maximum treatment period of 24 months. RESULTS: The majority of subjects (91%) had type 2 diabetes. They had a mean age of 55 years and 55% were women. For patients followed up at 6 months, their mean BMI at baseline was 39.5 kg/m2 with a mean HbA1c of 7.6%. The mean weight loss at 6 months was 7.1 kg (p < 0.001). Despite a significant average absolute HbA1c reduction of 0.62% (p < 0.001), the most notable gains were made by those with the highest baseline HbA1c values (a mean relative reduction of 20% for those above the 75th percentile). There were 50 patients treated with insulin at baseline and 47 at 6 months. Of those treated with insulin, the mean dose was 130 units at baseline and 90 units at 6 months (p < 0.001). Twenty patients (44.4%) initially treated with oral hypoglycaemic agents alone reduced their dose after 6 months (not significant). Despite marked improvement in insulin sensitivity (baseline mean, 1.24 units/kg; 6 month mean, 0.90 units/kg [p < 0.001]) there was no correlation with BMI change. The average cost of diabetes treatment at baseline was pound 1.16 per day and pound 0.83 at 6 months (p < 0.001). Age was the only independent predictor for insulin dose reduction. CONCLUSIONS: Orlistat appears to reduce the need for concomitant diabetes medication irrespective of weight loss, a reduction that is likely to represent a large cost offset for orlistat treatment.     

应用磺脲类药物和二甲双胍治疗2型糖尿病失效后补充第3种降糖药的选择

目的:对应用磺脲类药物和二甲双胍后血糖仍控制不佳的2型糖尿病患者,观察补充第3种药物控制血糖的效果和安全性。方法:119例2型糖尿病患者(年龄(56.1±14.0)岁,糖化血红蛋白A(1HbA1c)(9.1±1.6)%)分为3组,分别随机补充甘精胰岛素、罗格列酮、阿卡波糖,根据血糖调整3种药物用量。补充药物治疗24周前、后,分别测定3组患者的HbA1c、空腹血糖(FPG)、体质量等指标变化。结果:甘精胰岛素组血糖(HbA1c(-1.66±0.24)%,FPG(-3.68±0.28)mmol·L-1)改善比罗格列酮组(HbA1c(-1.15±0.17)%,FPG(-2.85±0.26)mmol·L-1)、阿卡波糖组(HbA1c(-0.75±0.22)%,FPG(-1.85±0.26)mmol·L-1)更明显(P<0.05)。与口服降糖药(罗格列酮或者阿卡波糖)比较,甘精胰岛素组患者外周水肿、胃肠道反应等发生几率更少或更轻微(P<0.05),仅体质量增加比阿卡波糖组明显(P<0.05)。3组患者低血糖发生率和治疗费用差异无统计学意义(P>0.05)。结论:对应用磺脲类药物和二甲双胍后血糖仍控制不佳的2型糖尿病患者,补充甘精胰岛素比补充口服降糖药(罗格列酮或者阿卡波糖)降糖效力更强,且副作用无明显增加。     

Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naïve type 2 diabetes patients: cost-effectiveness analysis in the UK setting

OBJECTIVES: To evaluate the long-term clinical and cost outcomes associated with biphasic insulin aspart 30/70 (BIAsp 30/70, premixed 30% soluble and 70% protaminated insulin aspart in one injection) compared to insulin glargine treatment in insulin-na?ve type 2 diabetes patients failing oral antidiabetic agents in the UK, based on findings recently reported from the INITIATE clinical trial. METHODS: The CORE Diabetes Model, a published, peer-reviewed and validated model of diabetes, was used to evaluate life expectancy, quality-adjusted life expectancy, cumulative incidence of complications and direct medical costs over patient lifetimes. The model simulates the range of diabetic complications and disease progression within a series of sub-models (cardiovascular disease, neuropathy, renal and eye disease) based on published data. Baseline cohort characteristics (54.5% male, mean age 52.45 years, mean diabetes duration 9 years, mean HbA(1c) 9.77%) and treatment effects were based on INITIATE. Costs were derived from published UK sources. The analysis was run over a 35-year time horizon (patient lifetime) from a third party payer perspective. Costs and clinical benefits were discounted at 3.5% per annum. Sensitivity analyses were performed. RESULTS: BIAsp 30/70 was associated with projected improvements in discounted life expectancy (0.19 +/- 0.20 years) and quality-adjusted life expectancy (0.19 +/- 0.14 quality-adjusted life years [QALYs]), as well as a reduced incidence of retinopathy and nephropathy complications, versus glargine. Total lifetime direct costs were 1319 pounds higher with BIAsp 30/70 than with glargine leading to an incremental cost-effectiveness ratio of 6951 pounds per QALY gained. CONCLUSIONS: This study is the first to address the long-term health economic implications of treating type 2 diabetes patients failing oral anti-diabetics with a biphasic insulin mix versus long-acting insulin. Our projections indicate that improved HbA1c levels with BIAsp 30/70 treatment are associated with improvements in life expectancy and quality-adjusted life expectancy, and that BIAsp 30/70 represents excellent value for money compared to insulin glargine in the UK.     

甘精胰岛素联合阿卡波糖治疗继发失效糖尿病

目的：观察甘精胰岛素联合阿卡波糖治疗继发失效2型糖尿病的疗效。方法：将62例2型糖尿病患者分为2组，治疗组应用甘精胰岛素联合阿卡波糖；对照组应用诺和灵30R联合二甲双胍治疗，比较两组治疗后的血糖和HbA1c以及胰岛素用量。结果：治疗组治疗后血糖和HbA1c水平均低于对照组（P〈0．05），且胰岛素用量更少（P〈0．01）。结论：甘精胰岛素联合阿卡波糖治疗能很好地控制继发失效2型糖尿患者的血糖。     

甘精胰岛素联合门冬胰岛素治疗2型糖尿病的临床评价

目的 评价甘精胰岛素联合门冬胰岛素治疗对2型糖尿病患者的血糖控制效果。方法 选取上海市长宁区天山中医医院内分泌科2013年1月-2016年1月治疗的2型糖尿病患者150例,随机分为两组（n=75）。其中对照组75例采用精蛋白生物合成人胰岛素注射液联合三餐门冬胰岛素治疗;试验组75例采用甘精胰岛素联合三餐门冬胰岛素治疗,均用药6个月。比较两组治疗前后空腹血糖、餐后2 h血糖和糖化血红蛋白（HbA1c）水平、两组生存质量和不良反应情况。结果 治疗6个月时,对照组和试验组患者的空腹血糖、餐后2 h血糖和HbA1c水平均较同组治疗前降低（P<0.05）,且试验组的空腹血糖和HbA1c水平均低于对照组的（P<0.05）,试验组生存质量明显优于对照组（P<0.05）;治疗3个月时,试验组的HbA1c水平低于对照组的,差异均有统计学意义（P<0.05）。试验组轻微低血糖、夜间低血糖和心脑血管发生率明显低于对照组（P<0.05）。结论 甘精胰岛素联合门冬胰岛素治疗对2型糖尿病患者的血糖控制效果显著,可长时间将血糖稳定在正常水平,患者不良反应发生率低、生存质量高。     

Glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes:real-world evidence from a Mediterranean area

Aims: To assess clinical characteristics and factors associated with glycated hemoglobin (HbA1c) reduction in type 2 diabetes (T2DM) patients initiating glucagon-like peptide-1 receptor agonists (GLP-1RAs).

Methods: Retrospective cohort study in patients with T2DM who initiated GLP-1RAs between 2007 and 2014 in primary health care centers in Catalonia (Spain). We evaluated changes in HbA1c and body weight at 6–12?months, and factors independently associated with achieving ≥1% HbA1c target reduction.

Results: Overall, 4242 patients (47.9% male; mean BMI 37.5?kg/m²) initiated a GLP-1RA. At 6–12?months, the mean HbA1c level decreased from the baseline 8.8% to 7.7% (?1.0%; SD?=?1.6). A 1% reduction in HbA1c was observed in 47.2% of patients. Patients lost a mean of 3.6?kg (SD?=?6.2). Sixty percent of patients reduced both HbA1c and body weight, and 17% achieved only one of these targets. Independent determinants of a 1% HbA1c reduction were baseline HbA1c, age, diabetes duration and being on insulin treatment. Reduction in weight or HbA1c and the proportion of patients achieving a HbA1c reduction of ≥1% was significantly larger among subjects prescribed liraglutide than exenatide and lixisenatide.

Conclusions: In this real-world, retrospective study, the magnitude of HbA1c and body weight reductions after addition of a GLP-1RA were similar to those observed in randomized controlled trials. Approximately 60% of patients attained reductions in both HbA1c and body weight, and there were significant differences among different drugs from this therapeutic group.     

Effects of insulin-oral hypoglycemic agents combined therapy in outpatients with type 2 diabetes

To evaluate the efficacy of combined insulin-OHAs therapy in subjects with NIDDM who received treatment with OHAs and insulin alone, we selected 60 outpatients divided in two groups: Group A: 36 subjects treated with OHAs therapy that received insulin treatment for secondary failure; Group B: 24 subjects in which OHAs therapy was added to insulin regimen to avoid the effects of hyperinsulinization. In the group A body weight increased significantly (+1.94 +/- 2.80 kg, p < 0.001 vs baseline), while in group B no gain of body weight was observed. Both groups showed a similar improvement of glycemic control. For the group A, the FPG and HbA1c decreased, respectively, from 14.64 +/- 3.76 to 8.72 +/- 2.92 mmol/l and from 9.10 +/- 0.30 to 7.20 +/- 0.53% at 6 months (p < 0.001). For the group B FPG and HbA1c decreased, respectively, from 12.05 +/- 3.49 to 8.24 +/- 3.01 mmol/l and from 8.3 +/- 0.1 to 6.8 +/- 0.13% (p < 0.001). Plasma cholesterol, triglycerides and uric acid concentrations did not show significant changes in either group. Insulin requirement in group A was 0.21 +/- 0.13 U/Kg/day. Despite of improvement of glycemia, total insulin requirement decreased in Group B from 0.53 +/- 0.25 to 0.34 +/- 0.2 U/Kg/day after OHAs therapy (p < 0.001). In the group A the bedtime insulin administration was prevalent (52.68%), while the most patients of group B needed a second or a third daily insulin injection (83.33%). In conclusion, in type 2 diabetic patients, therapy with combination of OHAs and insulin was associated with lower insulin doses and less weight gain.     

Cost-effectiveness and cost-utility of insulin glargine compared with NPH insulin based on a 10-year simulation of long-term complications with the Diabetes Mellitus Model in patients with type 2 diabetes in Switzerland

OBJECTIVE: The objective of this study was to evaluate the cost-effectiveness of insulin glargine compared with NPH insulin in patients with type 2 diabetes and in whom OAD (oral anti-diabetics) had failed in Switzerland. METHODS: Long-term diabetes outcomes were simulated with the Diabetes Mellitus Model (DMM) over a period of 10 years. The incidences of long-term complications (micro- and macrovascular events) were simulated for 10,000 patients over 10 years for six different scenarios. The scenarios were based on HbA1c reductions observed in clinical trials. For insulin glargine, HbA1c reductions of 0.96% (pessimistic case) and 1.24% (optimistic case) were simulated for three different HbA1c baseline values (10, 9 and 8%). For NPH insulin the HbA1c reduction was assumed to be 0.84%. A cost model and a utility model were developed in order to use the cumulated incidences of the simulations for the calculation of cost and QALYs (quality-adjusted life years). The unit costs of micro- and macrovascular events were assessed on the basis of published literature and guideline-projected resource-use estimations for Switzerland. Disutility values of diabetes-related long-term complications were derived from the literature. Total direct medical costs or QALYs were assessed by a combination of cumulated incidences of each event up to 10 years with the corresponding unit cost per event (in addition to the acquisition cost) or with disutility values per event, respectively. Events, total cost, and QALYs were discounted at 3%. In scenarios where no savings could be shown for insulin glargine, incremental cost-effectiveness ratios were calculated as the incremental cost per event prevented and the cost per QALY gained. RESULTS: Cost comparison demonstrated that insulin glargine is the dominant strategy for the optimistic case scenario starting at a baseline HbA1c value of 10% as savings in the management of complications exceeded the difference in acquisition costs after 8 years of treatment. Optimistic case scenarios for baseline HbA1c values of 9 and 8% achieved costs per QALY gained amounting to CHF 2,853 and CHF 5,711 and costs per event prevented amounting to CHF 2,054 and CHF 4,899, respectively. Pessimistic case scenarios for baseline HbA1c values of 10, 9 and 8% resulted in costs per QALY gained amounting to CHF 40,441, CHF 45,701 and CHF 49,468 and costs per event prevented amounting to CHF 27,742, CHF 32,451 and CHF 41,620, respectively. CONCLUSIONS: This study investigated the long-term health-economic implications of treating type 2 diabetes patients, in whom OAD had failed, with insulin glargine versus NPH insulin in Switzerland. The 10-year simulations demonstrated that the deltaHbA1c reductions of 0.4 and 0.12% achieved with insulin glargine led to a reduction of long-term complications, mortality and associated costs as well as to an improved quality of life. Insulin glargine proved to be cost-effective and represents good to excellent value for money compared to NPH insulin.