甘精胰岛素与格列美脲联合应用治疗口服降糖药控制不佳2型糖尿病的有效性和安全性

目的:本文针对口服降糖药控制不佳的2型糖尿病患者的治疗方案课题研究中,探究甘精胰岛素联合格列美脲用药措施的临床效果.方法:病例样本来源于我院2020年1月-2020年12月收录的88例口服降糖药控制不佳的2型糖尿病患者,依据计算机表法将患者均等分为44例采用低精蛋白胰岛素联合格列美脲治疗方案的对照组、44例甘精胰岛素联...     

甘精胰岛素联合格列美脲治疗控制欠佳2型糖尿病患者的疗效观察

84例口服降糖药血糖控制欠佳的2型糖尿病患者换用甘精胰岛素联合格列美脲治疗,在治疗第0周及16周分别记录三餐前、三餐后2小时、睡前血糖及HbA1c(糖化血红蛋白)。结果治疗16周后三餐前、三餐后2小时、睡前血糖及HbA1c均较基线水平显著下降。低血糖事件共发生6人次。结论口服降糖药血糖控制欠佳的2型糖尿病患者换用甘精胰岛素联合格列美脲治疗能有效并安全的控制血糖。     

地特胰岛素转换为甘精胰岛素实现血糖管理达标的2型糖尿病1例

1例2型糖尿病患者,院外使用地特胰岛素、门冬胰岛素联合口服降糖药血糖控制不佳,转换为甘精胰岛素、门冬胰岛素联合口服降糖药后,血糖平稳下降且餐后及睡前血糖下降明显,进而甘精胰岛素由20IU逐渐减量至10IU,无低血糖等不良反应发生。结论:地特胰岛素换用甘精胰岛素后,患者基本实现血糖管理达标,且胰岛素用量更少。     

甘精胰岛素联合口服降糖药与预混胰岛素对2型糖尿病患者血糖控制稳定性的影响

目的 对比短期内甘精胰岛素联合口服降糖药与预混胰岛素对2型糖尿病患者血糖控制、血糖稳定性及安全性的影响.方法 连续入选60例因血糖控制不佳初次使用胰岛素的2型糖尿病住院患者,随机分为甘精胰岛素联合口服降糖药物组(甘精组)和预混胰岛素组(预混组),分别给予甘精胰岛素每日一次皮下注射联合餐前口服降糖药以及给予门冬胰岛素30注射液每日两次皮下注射治疗.开始治疗2 w后,采用动态血监测测系统(CGMS)观察血糖波动情况,同时记录患者全天指血血糖并与人院时比较,记录患者胰岛素使用量以及低血糖情况.结果 两组患者入组时一般临床特征及生化指标无显著差异;治疗2 w后CGMS监测两组平均血糖(MBG),高血糖曲线下面积(AUC)无明显差别,甘精组血糖标准差(SD)、日内平均血糖波动幅度(MAGE)、低血糖曲线下面积(AUC)均显著低于预混组;甘精组胰岛素使用量及低血糖发生率显著低于预混组(均P＜0.05).结论 与预混胰岛素比较,甘精胰岛素联合口服降糖药物治疗2型糖尿病,降糖效果相当,血糖波动更小,低血糖发生率低.     

甘精胰岛素与精蛋白锌重组赖脯胰岛素治疗老年糖尿病疗效比较

68例老年糖尿病患者随机分为两组,甘精胰岛素联合口服药治疗组32人(1组)、精蛋白锌重组赖脯胰岛素治疗组36人(2组),比较治疗效果及不良反应发生情况。结果治疗后,两组空腹及餐后血糖、糖化血红蛋白均较前下降,体重变化不大,甘精胰岛素组低血糖发生率低于精蛋白锌重组赖脯胰岛素治疗组。结论甘精胰岛素联合口服降糖药可良好控制血糖,患者的依从性好,低血糖发生率低,可用于老年糖尿病的治疗。     

甘精胰岛素联合罗格列酮在2型糖尿病初始胰岛素治疗中的疗效观察

目的观察甘精胰岛素与罗格列酮联用治疗口服降糖药血糖控制差的2型糖尿病患者的疗效及安全性。方法选取口服降糖药血糖控制差的2型糖尿病患者56例,随机分为甘精胰岛素组和中效精蛋白胰岛素组,两组均联合口服罗格列酮。持续观察12周,比较两组空腹血糖（FBG）、餐后2小时血糖（2hPBG）、糖化血红蛋白（HbAlc）、空腹胰岛素（FINS）、胰岛素用量、空腹血糖达标时间、短效胰岛素注射次数、低血糖出现次数,计算胰岛素抵抗指数（IRI）,监测肝肾功能、血常规及体重增加情况。结果甘精胰岛素组FBG达标时间、HbAlc水平及出现低血糖次数、体重增加值均低于中效精蛋白胰岛素组（P〈0．05）;平均甘精胰岛素使用剂量大于中效精蛋白胰岛素;加用短效胰岛素诺和灵R的量和注射次数及胰岛素总量显著低于中效精蛋白胰岛素组（P〈0．01）。结论口服降糖药疗效差的2型糖尿病患者应用甘精胰岛素联合罗格列酮治疗,有更显著的降糖效果,临床应用安全。     

地特胰岛素与甘精胰岛素治疗老年2型糖尿病的疗效对比

目的比较口服降糖药控制欠佳的老年2型糖尿病患者加用地特胰岛素或甘精胰岛素治疗的有效性、安全性和体重变化。方法将56例口服降糖药控制欠佳的老年2型糖尿病患者,随机分为A、B组,每组28例。两组均保持原有的口服降糖药方案不变,A组给予睡前皮下注射地特胰岛素治疗,B组给予睡前皮下注射甘精胰岛素治疗,治疗3个月。对两组治疗前后的空腹血糖、餐后2 h血糖、糖化血红蛋白、体重变化及低血糖发生率情况进行比较。结果两组治疗后空腹血糖、餐后2 h血糖、糖化血红蛋白与治疗前比较差异均有统计学意义(均P<0.05),但两组之间的差异无统计学意义(均P>0.05);B组治疗后体重增加较A组多(P<0.05);两组之间的低血糖发生率比较差异无统计学意义(P>0.05)。结论口服降糖药控制欠佳的老年2型糖尿病加用地特胰岛素或甘精胰岛素均能有效控制血糖,且低血糖发生率均较低;相比甘精胰岛素,地特胰岛素减少体重增加更具优势。     

甘精胰岛素在2型糖尿病治疗中的应用

目的 观察甘精胰岛素治疗2型糖尿病(T2DM)的临床疗效.方法 将72例血糖控制不良的T2DM患者随机分为观察组和对照组各36例,两组均口服降糖药,观察组加用甘精胰岛素,对照组加用诺和灵N,观察两组血糖达标时间、空腹血糖、日间血糖漂移、低血糖发生率.结果 观察组血糖达标时间、空腹血糖、日间血糖漂移、低血糖发生率分别为(8.2±2.5)d、(5.0±1.3)mmol/L、(7.1±1.5)mmol/L、5.6%,对照组分别为(11.1±1.8)d、(5.9±1.4)mmol/L、(7.3±1.3)mmol/L、13.9%,两组比较P均＜0.01.结论 应用口服降糖药基础上加用甘精胰岛素可有效控制血糖,且低血糖发生率低.     

甘精胰岛素联合瑞格列奈治疗老年2型糖尿病患者的疗效与安全性

目的 观察甘精胰岛素注射液联合口服降糖药物瑞格列奈对老年2型糖尿病患者的血糖控制情况和低血糖的风险. 方法 选择口服降糖药物血糖控制不良的老年2型糖尿病患者64例,随机分为甘精胰岛素组(简称甘精组)和预混胰岛素组(诺和灵30R,简称预混组),每组各32例.甘精组在每天3餐前口服瑞格列奈的基础上,每晚22时注射甘精胰岛素1次;预混组每天早、晚餐前分别注射诺和灵30R预混胰岛素;根据空腹血糖及餐后血糖的水平,每3天调整瑞格列奈及胰岛素剂量,以空腹血糖<7.2 mmol/L,餐后血糖<10.0 mmol/L为治疗目标,共治疗16周,观察血糖控制和低血糖发生情况. 结果 治疗16周后两组的全天血糖谱和糖化血红蛋白(HbAlc)有明显下降(P<0.05),甘精组全天各时点血糖均值低于预混组,其中午餐后、晚餐后2 h血糖与预混组比较,差异有统计学意义(均为P<0.05),甘精组HbAlc值明显低于预混组(P<0.05);体质指数(BMI)甘精组无明显增加(P>0.05),预混组BMI较治疗前明显增加(P相似文献   

甘精胰岛素联合口服降糖药治疗2型糖尿病1例

1例2型糖尿病患者使用口服降糖药物治疗血糖控制不佳,加用甘精胰岛素治疗3个月,空腹静脉血糖由10.6mmol/L降至6.06mmol/L,糖化血糖蛋白由8.7%降至7.9%。患者监测餐后2小时指血血糖11~14mmol/L,加用磷酸西格列汀100mg qd治疗3个月。后监测空腹指血血糖5-7mmol/L,餐后2小时指血血糖8~11mmol/L,复查糖化血红蛋白7.2%。无不良反应和低血糖发生。结论:口服降糖药控制不佳的2型糖尿病患者,调整为甘精胰岛素联合口服降糖药后可有效控制血糖。     

Evaluation of the superiority of insulin glargine as basal insulin replacement by continuous glucose monitoring system

To evaluate the superiority of insulin glargine as basal insulin replacement by continuous glucose monitoring system (CGMS). Twenty-four patients with type 2 diabetes mellitus (T2DM) whose blood glucose was not well controlled with sulphanylureas were enrolled. At first, they were treated with extended-release glipizide (glucotrol XL) 5mg/d before breakfast for 2 weeks, then randomized to combination treatment with glargine (16 patients) or NPH (8 patients) and treated for 12 weeks. CGMS were carried in the second week after treatment with glucotrol XL, and in the 12th week after combination treatment. The data of CGMS showed: (1) When FPG were well controlled in both groups (glargine group versus NPH group: 6.0+/-1.0 mmol/L versus 5.8+/-1.3 mmol/L), the blood glucose level at 3:00 a.m. (5.1+/-0.9 mmol/L versus 4.2+/-0.8 mmol/L) were higher (P<0.05), TPG< or =3.0 mmol/L at night were lower (2.56+/-1.79 versus 5.88+/-1.96), and the rate of nocturnal hypoglycemia (1/16 versus 4/8) were less (P=0.028) in glargine group than those in NPH group. (2) CGMS showed that the daily blood glucose profile excursion were more smoother in glargine group than those in NPH group. In conclusion, it was confirmed with CGMS that compared with traditionally basal insulin replacement with NPH, the combination treatment with glargine injection at bedtime may be predominant for stabilizing the daily blood glucose profile excursion and decreasing the nocturnal hypoglycemia events incidence. So glargine may be a more ideal basal insulin replacement than NPH.     

A comparison of bedtime insulin glargine with bedtime neutral protamine hagedorn insulin in patients with type 2 diabetes: subgroup analysis of patients taking once-daily insulin in a multicenter, randomized, parallel group study

BACKGROUND: Basal insulin is frequently administered once daily. This subgroup analysis of a multicenter, randomized, parallel study compared insulin glargine (Lantus Aventis Pharmaceuticals, Bridgewater, NJ) with neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes, evaluating only patients treated previously with once-daily NPH insulin. METHODS: Patients received bedtime insulin glargine or NPH insulin, with preprandial regular insulin. One hundred patients (mean age, 57.9 years; mean glycohemoglobin, 8.4%; mean fasting blood glucose, 167 mg/dL) were treated for up to 28 weeks. RESULTS: Patients treated with insulin glargine (n = 52) and NPH insulin (n = 48) achieved similar reductions from baseline in glycohemoglobin (-0.41% versus -0.46%) and fasting blood glucose (-22 mg/dL versus -22 mg/dL) at week 28. The proportion of patients reaching target fasting blood glucose (<120 mg/dL) at 28 weeks was 34.2% with insulin glargine and 24.4% with NPH insulin. Similar proportions of patients achieved glycohemoglobin less than 7% and less than 8% in both groups. Baseline and week-28 mean daily doses of insulin glargine (27.3 IU versus 36.4 IU) were similar to NPH insulin doses (25.5 IU versus 30.2 IU). However, significantly fewer patients reported one or more episodes of hypoglycemia with insulin glargine (46.2%) versus NPH insulin (60.4%; P < 0.05). Significantly fewer patients also reported one or more symptomatic episodes confirmed by blood glucose less than 50 mg/dL with insulin glargine (17.3%) versus NPH insulin (31.3%; P < 0.005). CONCLUSION: Bedtime insulin glargine is as effective as bedtime NPH insulin in improving glycemic control, with significantly less hypoglycemia.     

甘精胰岛素联合口服降糖药物对血糖控制不佳的2型糖尿病患者的疗效观察

目的 评价甘精胰岛素(来得时(R))与盐酸吡格列酮和二甲双胍联合应用治疗口服降糖药物控制不佳的2型糖尿病患者的有效性和安全性.方法 采用随机法将78例口服降糖药物控制不佳的2型糖尿病患者分为A、B两组.A组为甘精胰岛素(来得时(R))组,B组为精蛋白锌胰岛素(诺和灵N)组,两组均口服吡格列酮和二甲双胍,观察治疗后空腹血...     

Safety and efficacy of insulin glargine (HOE 901) versus NPH insulin in combination with oral treatment in Type 2 diabetic patients

Aims A European, randomized, 29‐centre, open‐label study compared the safety and efficacy of two formulations of insulin glargine and neutral protamine Hagedorn (NPH) human insulin, in combination with oral agents, in patients with Type 2 diabetes mellitus (DM). Methods Two‐hundred‐and‐four patients with Type 2 DM, in whom oral treatment alone was inadequate, were randomized to insulin glargine with 30 µg/ml zinc [insulin glargine (30)], or insulin glargine with 80 µg/ml zinc [insulin glargine (80)] or NPH insulin subcutaneously once daily. Insulin was titrated to aim for fasting blood glucose (FBG) values between 4 and 7 mmol/l. All participants received oral therapy during the 3‐week titration phase and 1‐week maintenance phase of the trial. Results No differences between treatment groups were observed in adjusted mean fasting plasma glucose; significant decreases of 3.4 mmol/l, 3.5 mmol/l and 3.1 mmol/l were observed within the insulin glargine (30), insulin glargine (80) and NPH insulin groups, respectively (P < 0.0001 in each case). No differences between groups, but significant changes within groups, were observed in self‐monitored FBG, mean FBG, blood glucose profile, stability of FBG, nocturnal blood glucose, fasting serum C‐peptide, non‐esterified fatty acids, haemoglobin A_1c, fructosamine and fasting serum insulin. A significantly greater proportion of NPH insulin patients experienced symptomatic nocturnal hypoglycaemia (19.1 NPH group vs. 7.3% glargine groups; P = 0.0123). Both insulins were well tolerated; one patient in each group experienced an injection site reaction. Conclusions Insulin glargine is as safe and effective as NPH insulin given once daily and in this study caused fewer episodes of nocturnal hypoglycaemia. Diabet. Med. 20, 545–551 (2003)     

A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes

BACKGROUND: To compare insulin glargine with NPH human insulin for basal insulin supply in adults with type 1 diabetes. METHODS: People with type 1 diabetes (n = 585), aged 17-77 years, were randomized to insulin glargine once daily at bedtime or NPH insulin either once- (at bedtime) or twice-daily (in the morning and at bedtime) according to their prior treatment regimen and followed for 28 weeks in an open-label, multicentre study. Both groups continued with pre-meal unmodified human insulin. RESULTS: There was no significant difference between the two insulins in change in glycated haemoglobin from baseline to endpoint (insulin glargine 0.21 +/- 0.05% (mean +/- standard error), NPH insulin 0.10 +/- 0.05%). At endpoint, self-monitored fasting blood glucose (FBG) had decreased similarly in each group (insulin glargine -1.17 +/- 0.12 mmol/L, NPH insulin -0.89 +/- 0.12 mmol/L; p = 0.07). However, people on >1 basal insulin injection per day prior to the study had a clinically relevant decrease in FBG on insulin glargine versus NPH insulin (insulin glargine -1.38 +/- 0.15 mmol/L, NPH insulin -0.72 +/- 0.15 mmol/L; p < 0.01). No significant differences in the number of people reporting >or=1 hypoglycaemic episode were found between the two groups, including severe and nocturnal hypoglycaemia. Insulin glargine was well tolerated, with a similar rate of local injection and systemic adverse events versus NPH insulin. CONCLUSIONS: A single, bedtime, subcutaneous dose of insulin glargine provided a level of glycaemic control at least as effective as NPH insulin, without an increased risk of hypoglycaemia.     

Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes.

AIMS: To compare blood glucose control using insulin glargine + insulin lispro with that on NPH insulin + unmodified human insulin in adults with Type 1 diabetes managed with a multiple injection regimen. METHODS: In this 32-week, five-centre, two-way cross-over study, people with Type 1 diabetes (n = 56, baseline HbA1c 8.0 +/- 0.8%) were randomized to evening insulin glargine + mealtime insulin lispro or to NPH insulin (once- or twice-daily) + mealtime unmodified human insulin. Each 16-week period concluded with a 24-h inpatient plasma glucose profile. RESULTS: HbA1c was lower with glargine + lispro than with NPH + human insulin [7.5 vs. 8.0%, difference -0.5 (95% CI -0.7, -0.3) %, P < 0.001]. This was confirmed by an 8% lower 24-h plasma glucose area under the curve (AUC) (187 vs. 203 mmol l(-1) h(-1), P = 0.037), a 24% reduction in plasma glucose AUC > 7.0 mmol/l1 (47 vs. 62 mmol l(-1) h(-1), P = 0.017) and a 15% lower post-prandial plasma glucose AUC (75 vs. 88 mmol l(-1) h(-1), P = 0.002). There was no reduction in night-time plasma glucose AUC or increase in plasma glucose area < 3.5 mmol/l. Monthly rate of nocturnal hypoglycaemia was reduced by 44% with glargine + lispro (0.66 vs. 1.18 episodes/month, P < 0.001). CONCLUSIONS: Compared with NPH insulin + unmodified human insulin, the combination of insulin glargine with a rapid-acting insulin analogue as multiple-injection therapy for Type 1 diabetes improves overall glycaemic control as assessed by HbA1c and 24-h plasma glucose monitoring to a clinically significant degree, together with a reduction in nocturnal hypoglycaemia.     

Glargine is superior to neutral protamine Hagedorn for improving glycated haemoglobin and fasting blood glucose levels during intensive insulin therapy

AIM: To compare glycaemic control and symptomatic hypoglycaemia rates with glargine versus neutral protamine Hagedorn (NPH) in poorly controlled type 1 diabetes patients. METHODS: Patients (n = 125) received preprandial insulin lispro and either glargine (n = 62) or NPH (n = 63) at bedtime for 30 weeks in a multicentre, randomized, single-blind (a blinded investigator made titration decisions) study. Basal insulin dosage was titrated to achieve fasting blood glucose (FBG) values < 5.5 mmol/L. RESULTS: Baseline characteristics were similar for the two groups (mean diabetes duration 17.5 +/- 10.1 years) except mean glycated haemoglobin (HbA(1c)), which was lower in the glargine versus NPH group (9.2 +/- 1.1% vs 9.7 +/- 1.3%; P < 0.02). At end-point, mean HbA(1c) was 8.3 versus 9.1% for the glargine versus NPH groups. Adjusted least-squares mean (LSM) change from baseline was -1.04 versus -0.51%, a significant treatment benefit of 0.53% for HbA(1c) in favour of glargine (P < 0.01). Mean baseline FBG were similar for the glargine and NPH groups (11.2 vs 11.4 mmol/L). The means for end-point FBG were 7.9 versus 9.0 mmol/L. Adjusted LSM change from baseline was -3.46 versus -2.34 mmol/L, with a significant difference of 1.12 mmol/L in favour of glargine (P < 0.05). There were similar total numbers of daytime mild, moderate or severe hypoglycaemia episodes in the two treatment arms. However, significantly fewer moderate or severe nocturnal hypoglycaemic episodes were observed in the glargine group (P = 0.04 and P = 0.02). CONCLUSION: Glargine is superior to NPH for improving HbA(1c) and FBG levels during intensive insulin therapy in patients with type 1 diabetes, and is associated with less severe nocturnal hypoglycaemia.     

Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with Type 1 diabetes mellitus given meal-time lispro insulin.

BACKGROUND: Glargine is a long-acting insulin analogue potentially more suitable than NPH insulin in intensive treatment of Type 1 diabetes mellitus (T1 DM), but no study has proven superiority. The aim of this study was to test superiority of glargine on long-term blood glucose (BG) as well as on responses to hypoglycaemia vs. NPH. METHODS: One hundred and twenty-one patients with T1 DM on intensive therapy on four times/day NPH and lispro insulin at each meal, were randomized to either continuation of NPH four times/day (n = 60), or once daily glargine at dinner-time (n = 61) for 1 year. Lispro insulin at meal-time was continued in both groups. In 11 patients from each group, responses to stepped hyperinsulinaemic-hypoglycaemia were measured before and after 1 year's treatment. RESULTS: Mean daily BG was lower with glargine [7.6 +/- 0.11 mmol/l (137 +/- 2 mg/dl)] vs. NPH [8.1 +/- 0.22 mmol/l (146 +/- 4 mg/dl)] (P < 0.05). HbA(1c) at 4 months did not change with NPH, but decreased with glargine (from 7.1 +/- 0.1 to 6.7 +/- 0.1%), and remained lower than NPH at 12 months (6.6 +/- 0.1%, P < 0.05 vs. NPH). Frequency of mild hypoglycaemia [self-assisted episodes, blood glucose < or = 4.0 mmol/l (72 mg/dl)] was lower with glargine vs. NPH (7.2 +/- 0.5 and 13.2 +/- 0.6 episodes/patient-month, P < 0.05). After 1 year, NPH treatment resulted in no change of responses to hypoglycaemia, whereas with glargine plasma glucose, thresholds and maximal responses of plasma adrenaline and symptoms to hypoglycaemia improved (P < 0.05). CONCLUSIONS: The simpler glargine regimen decreases the percentage of HbA(1c) and frequency of hypoglycaemia and improves responses to hypoglycaemia more than NPH. Thus, glargine appears more suitable than NPH as basal insulin for intensive treatment of T1 DM.     

Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus

OBJECTIVES: To compare initiation of insulin therapy by adding once-daily insulin glargine to oral antidiabetic agents (OADs) with switching patients to premixed 30% regular, 70% human neutral protamine hagedorn insulin (70/30) without OADs. DESIGN: A 24-week, multicenter, open, randomized (1:1), parallel study. SETTING: Three hundred sixty-four poorly controlled patients with type 2 diabetes mellitus were treated with once-daily morning insulin glargine with continued OADs (glimepiride+metformin) (glargine+OAD) or twice-daily 70/30 alone. Insulin dosage in each group was titrated to target fasting blood glucose (FBG) of 100 mg/dL or less (or=6.7 mmol/L) and hemoglobin (Hb)A(1c) levels between 7.5% and 10.5% on OADs (glargine+OAD, n=67; 70/30, n=63). MEASUREMENTS: HbA(1c), FBG, hypoglycemia, insulin dose, and adverse events were recorded. RESULTS: HbA(1c) decreased from baseline to endpoint for both glargine+OAD (from 8.8% to 7.0%) and 70/30 (from 8.9% to 7.4%); adjusted mean HbA(1c) decrease for glargine+OAD and 70/30 was -1.9% and -1.4%, respectively (P=.003). More patients reached HbA(1c) of 7.0% or less without confirmed nocturnal hypoglycemia with glargine+OAD (n=37, 55.2%) than with 70/30 (n=19, 30.2%) (P=.006). FBG decreased significantly more with glargine+OAD (-57 mg/dL (-3.2 mmol/L)) than with 70/30 (-40 mg/dL (-2.2 mmol/L)) (P=.002). Patients treated with glargine+OAD experienced fewer episodes of any hypoglycemia (3.68/patient-year) than did those treated with 70/30 (9.09/patient-year) (P=.008). CONCLUSION: In elderly patients, addition of once-daily morning glargine+OAD is a simple regimen to initiate insulin therapy, restoring glycemic control more effectively and with less hypoglycemia than twice-daily 70/30 alone.     

Spotlight on Insulin Glargine in Type 1 and 2 Diabetes Mellitus

Insulin glargine is a recombinant human insulin analog produced by DNA technology using a nonpathogenic strain of Escherichia coli. Two modifications of human insulin result in a stable molecule which is soluble in slightly acidic conditions (pH 4.0) and precipitates in the neutral pH of subcutaneous tissue. Because of these properties, absorption of insulin glargine is delayed and the analog provides a fairly constant, basal insulin supply without peaks in plasma insulin levels for approximately 24 hours, similar to that achieved by a continuous subcutaneous insulin infusion. Insulin glargine is indicated as a once daily subcutaneous injection to provide basal glycemic control in adults and children aged >6 years with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Fasting plasma glucose and fasting blood glucose levels generally improved to a greater extent in patients with type 1 diabetes mellitus receiving insulin glargine than patients who administered Neutral Protamine Hagedorn (NPH) insulin. In patients with type 1 or 2 disease, glycosylated hemoglobin levels were slightly reduced and to a similar extent with insulin glargine and NPH insulin. Most clinical trials in patients with type 1 or 2 diabetes mellitus demonstrated a lower incidence of hypoglycemia, especially nocturnal hypoglycemia, with insulin glargine compared with NPH insulin. One of the most common adverse events with insulin glargine treatment was injection site pain which, in some studies, occurred more frequently than in patients receiving NPH insulin. In all cases the symptoms were mild and treatment discontinuation was not required. Otherwise, the drug is well tolerated and does not appear to be immunogenic. In conclusion, insulin glargine once a day provides basal control of glycemia for approximately 24 hours without inducing peaks in plasma insulin levels in patients with type 1 or 2 diabetes mellitus. In long-term, well designed trials insulin glargine once daily improved glycemic control at least as effectively as NPH insulin given once or twice daily. The drug was well tolerated and in most studies the incidence of nocturnal hypoglycemia was significantly less in patients treated with insulin glargine compared with patients receiving NPH insulin. Therefore, insulin glargine is likely to be a useful addition to the armamentarium of insulin therapy by establishing basal glycemic control with once daily administration and a reduced risk of nocturnal hypoglycemia.