Safety Of Insulin Glargine Research Articles

Efficacy and Safety of Insulin Glargine 300U/mL in People with Type2 Diabetes Uncontrolled on Basal Insulin: The 26-Week Interventional, Single-Arm ARTEMIS-DM Study.

IntroductionThe efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.MethodsThe ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA1c] 7.5–10%) on BI were switched to Gla-300. The primary endpoint was change in HbA1c from baseline to 26 weeks. Key secondary endpoints were changes in HbA1c (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.ResultsA total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA1c 8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA1c (− 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.ConclusionIn people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.ClinicalTrials.gov identifierNCT03760991.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01271-7.

Real-world evidence on the use of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) in people with suboptimally controlled type 2 diabetes in Romania: a prospective cohort study (STAR.Ro)

ObjectivesTo assess the effectiveness and safety of insulin glargine and lixisenatide (iGlarLixi) fixed-ratio combination on a cohort of Romanian adults with type 2 diabetes (T2D).DesignOpen-label, 24-week, prospective cohort study.Setting65 secondary...

A randomized trial to investigate the efficacy and safety of insulin glargine in hyperglycemic acute stroke patients receiving intensive care

This pilot, randomized, open-label controlled study compared the basal–bolus regimens of insulin glargine (IG) and neutral protamine Hagedorn (NPH) insulin in stroke patients with hyperglycemia receiving intensive care. The study recruited acute stroke patients requiring intensive care within 72 h (h) of onset and had blood glucose > 200 mg/dL. 50 patients received IG (n = 26) or NPH (n = 24) with added short-acting prandial regular insulin over a 72-h period. The primary end point was the percentage of glucose within 80–180 mg/dL assessed through continuous glucose monitoring. The baseline characteristics were comparable, except the IG had higher glucose pre-randomization than the NPH (290.69 ± 82.31 vs. 246.04 ± 41.76 mg/dL, P = 0.021). The percentage of time with glucose between 80 and 180 mg/dL was 45.88 ± 27.04% in the IG and 53.56 ± 22.89% in the NPH (P = 0.341) and the percentage of glucose reduction was 31.47 ± 17.52% in the IG and 27.28 ± 14.56% in the NPH (P = 0.374). The percentage of time with glucose < 60 mg/dL was 0.14 ± 0.49% in the IG and 0.47 ± 1.74% in the NPH. Poststroke outcomes were not significantly different. In conclusion, IG is safe and equally effective as an NPH-based basal-bolus regimen for acute stroke patients with hyperglycemia receiving intensive care.Trial registration ClinicalTrials.gov, NCT02607943. Registered 18/11/2015, https://clinicaltrials.gov/ct2/show/NCT02607943.

1045-P: Basal Insulins in Advanced Renal Failure: Time for a Paradigm Shift

Aim: To compare efficacy and safety of IDeg and IGlarU100 in T2DM patients with Stage 3 or 4 CKD. Methods: This single-centered, retrospective, observational study evaluates efficacy and safety of insulin glargine and insulin degludec in CKD with eGFR 60 and below. T2DM patients with DKD receiving IGlarU100 or IDeg for 24 weeks and beyond were included. Data relating to anthropometry, blood pressure, renal parameters, and glycaemic control were analysed. Results: In advanced renal failure, IDeg caused statistically significant less hypoglycemia than IGlarU100. Ironically, reverse occurred in CKD stage 3A which may be contributed by concomitant usage of SUs. Both drugs were found to be similarly efficacious in this population. Conclusion: IDeg has lower rate of hypoglycemia in advanced renal failure T2DM patients and may be a safer option to use in this scenario. Disclosure S. Roy Chaudhuri: None. A. Majumder: None. D. Sanyal: None.

Fixed-Ratio Combination of Insulin and GLP-1 RA in Patients with Longstanding Type 2 Diabetes: A Subanalysis of LixiLan-L.

IntroductionWith longer duration and progression of type 2 diabetes (T2D), β-cell function deteriorates and insulin therapy often becomes necessary. Glucagon-like peptide-1 receptor agonists such as lixisenatide that do not rely only on β-cell function and glucagon suppression primarily, but also lower glucose by other (insulin-independent) mechanisms such as delayed gastric emptying, may be appropriate adjuvant therapy to basal insulin in patients with longstanding T2D.MethodsWe assessed the efficacy and safety of insulin glargine (iGlar) versus iGlarLixi, a fixed-ratio combination of iGlar and lixisenatide, stratified by quartiles (Q) of T2D duration (≤ 7.305 [Q1], > 7.305 to ≤ 10.75 [Q2], > 10.75 to ≤ 15.67 [Q3], and > 15.67 years [Q4]) in the LixiLan-L trial (N = 736).ResultsAcross all quartiles, the reduction in glycated haemoglobin was greater with iGlarLixi versus iGlar, and the difference was most pronounced in patients with the longest duration (Q4; least squares mean difference [standard error] − 0.62 [0.13], P < 0.0001). Additionally, hypoglycaemia rates were significantly lower with iGlarLixi versus iGlar in patients in Q4 (3.3 vs. 6.9 events/patient-year, P < 0.0001).ConclusioniGlarLixi lowered glycated haemoglobin more versus iGlar regardless of T2D duration, with benefit retained even among patients with the longest T2D duration.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-020-00797-y) contains supplementary material, which is available to authorized users.

A Retrospective Observational Study of Insulin Glargine in Type 2 Diabetic Patients with Advanced Chronic Kidney Disease.

BackgroundThe majority of type 2 diabetes mellitus (T2DM) subjects are on multiple oral antidiabetic drugs (OADs) but as kidney dysfunction progresses, many of them become inappropriate. Basal insulin, such as glargine, is generally recommended as first-line insulin therapy by most guidelines. However, there is limited data on the safety and efficacy of the use of glargine in diabetic kidney disease (DKD).ObjectivesTo evaluate the efficacy and safety of insulin glargine in T2 DM patients with Stage 3 or 4 chronic kidney disease (CKD).Material and methodsThis single-centered, retrospective, observational study evaluates the efficacy and safety of insulin glargine in DKD with estimated glomerular filtration rate (eGFR) 60 and below. Non-pregnant T2DM patients with DKD receiving insulin glargine for 24 weeks and beyond were included for analysis. Data relating to anthropometric measurements, blood pressure, renal parameters, and glycemic control were analyzed. Sixty patients were in CKD Stage 3 (group A) and 35 patients were in CKD Stage 4 (group B). Glargine was started at an initial dose of 10 units daily as per the standard of care followed by the institute and up-titrated or down-titrated using a prespecified algorithm to maintain fasting plasma glucose between 90 mg/dl and 130 mg/dl.ResultsThe study achieves (1.2%) (13.2 mmol/mol) of glycosylated hemoglobin (HbA1C) reduction in both groups (Group A and Group B) and a significant reduction in fasting and postprandial glucose values without a significant weight change over the study period. Out of 95 patients, 32 (33.68%) had documented hypoglycemia; out of them, 9 (28.2%) had severe hypoglycemia, and 8 (25%) had nocturnal hypoglycemia (either mild or severe). No change in weight, blood pressure, or eGFR was observed during the study period.ConclusionsTreatment with glargine-based basal insulin therapy in diabetes with Stage 3 or Stage 4 CKD was efficacious in reducing glycemic parameters and was safe without significant changes in weight and hypoglycemia.

Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe

Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe

Clinical efficacy of insulin glargine combined with oral hypoglycemic agents in the treatment of type 2 diabetes mellitus

Objective To evaluate the efficacy and safety of insulin glargine combined with oral hypoglycemic agents in the treatment of type 2 diabetes mellitus (T2DM). Methods From December 2012 to December 2016, 60 patients with T2DM in Shuozhou Infectious Disease Hospital were divided into observation group and control group according to the random number table, with 30 cases in each group.The control group received premixed insulin(insulin aspart 30) combined with glimepiride treatment, the observation group was treated with insulin glargine combined with glimepiride for 12 weeks.The blood glucose index, fasting blood glucose(FBG), postprandial 2 hours blood sugar(2hPG), glycosylated hemoglobin(HbA1c), plasma insulin(FINS) and insulin resistance index(HOMA2-IR) were compared between the two groups before and after treatment. Results After treatment, the FBG[(5.87±1.52)mmol/L vs.(6.79±1.98)mmol/L], 2hPG[(6.87±1.31)mmol/L vs.(7.89±1.65)mmol/L] and HbA1c[(7.14±1.18)% vs.(7.99±1.27)%] in the observation group were significantly better than those in the control group, the differences were statistically significant(t=4.636, 4.795, 3.896, all P<0.05). The FINS [(6.12±1.35)IU/mL vs.(7.38±1.65)IU/mL] and HOMA-IR[(2.80±0.29) vs.(3.21±0.34)] in the observation group improved significantly better than those in the control group, the differences were statistically significant(t=5.646, 3.926, all P<0.05). The incidence rate of hypoglycemia in the observation group was significantly lower than that in the control group(9.5% vs.37.8%), the difference was statistically significant(χ2=4.464, P<0.05). Conclusion Insulin glargine can significantly improve blood glucose levels and glycosylated hemoglobin levels, and help to improve insulin resistance in patients with T2DM.The incidence rate of hypoglycemia is low and the safety of the drugs is high. Key words: Diabetes mellitus, Type 2; Hypoglycemia; Glargine; Insulin

Effectiveness and safety of insulin glargine versus detemir analysis in patients with type 1 diabetes: systematic review and meta-analysis.

Diabetes mellitus type 1 (DM1) is an autoimmune disease characterized by metabolic destruction of pancreatic cells responsible for insulin production, with treatment based on replacing insulin. Long-acting insulin analogs are indicated for patients with DM1 who exhibit important oscillations of their daily glycemia, despite its higher cost. Our study objective was to evaluate the effectiveness and safety of two long-acting insulins, insulin glargine and detemir, in treating patients with DM1. We undertook a systematic review with meta-analysis of observational studies (cohort and registry) available in the databases and the gray literature, and a complementary search in the Diabetes Care journal. Outcomes assessed were: glycated hemoglobin concentration; fasting plasma or capillary glucose; occurrence of episodes of severe hypoglycemia and occurrence of nocturnal hypoglycemia. The assessment of methodological quality was performed using the Newcastle score. The meta-analyses were performed on software Review Manager® 5.2. Out of 705 publications, 8 cohort studies were included. The quality of these studies was classified as high. In the meta-analysis, results regarding episodes of severe hypoglycemia (p = 0.02) and fasting glucose (p = 0.01) were in favor of detemir. The glycated hemoglobin (p = 0.49; I2 = 89) showed high heterogeneity and no statistically significant difference between the two. The meta-analysis of total insulin dose favored glargine (p = 0.006; I2 = 75). The rates of nocturnal hypoglycemia (NH) were evaluated only for one study and showed a significant reduction of NH after therapy with detemir, (p < 0.0001). Although some outcomes were favorable to detemir insulin analog, it has not been possible to identify important differences of effectiveness and safety between the two analogs. These results can help in the current debate on the inclusion of long-acting analogs on the list of reimbursed medicines in Brazil, especially with the recent introduction of an insulin glargine biosimilar at a considerably lower price.

Short Term Efficacy and Safety of Insulin Glargine in Type 2 Diabetes Inadequately Controlled with Single or Two Oral Agents: A Prospective, Open Label Study.

Basal insulin is among the second line treatment options for Type 2 Diabetes Mellitus (T2DM). Efficacy and safety of basal insulin in patients of T2DM, uncontrolled with Oral Antidiabetic Agents (OAAs) remains understudied in the Indian setting. To assess the efficacy and safety of insulin glargine in patients with T2DM who have uncontrolled glycaemic levels despite single or two OAAs therapy. In this prospective, open label study, T2DM patients above 40 years of age, having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) above 8% and/or fasting glucose level of 140 mg/dl and above] with single or two OAAs over three consecutive months were included. Dosing of insulin glargine was adjusted as per Fasting Blood Glucose (FBG) and Post Prandial Blood Glucose (PPBG) levels. Patients were followed for 12 weeks and data was analysed by comparing 12th week findings to baseline values. In 40 cases included in final analysis, mean age was 56.35 ± 6.77 years, 52.5% were females and mean body mass index was 26.96 ± 4.59 kg/m2. Compared to baseline, significant reduction in HbA1c, FBG and PPBG blood glucose (all p<0.05) was seen. HbA1c goal of < 7% was achieved in 37.5% cases. Systolic (p>0.05) and diastolic (p<0.05) blood pressures reduced at 12 weeks as compared to baseline. Increase in weight was modest with mean increase of 1.06 kg (p>0.05). Overall, 14 symptomatic hypoglycaemia events were observed with none being severe. Short term administration of insulin glargine is effective in reducing glycaemia and is safe with lower rates of severe hypoglycaemia. It can be considered in patients with uncontrolled T2DM on mono- or two- OAAs treatment.

Effectiveness and safety of insulin glargine plus glimepiride after 6 months of treatment among patients with type 2 diabetes mellitus who failed premixed insulin: An observational study conducted in Egypt

Objective This study aimed to evaluate the effectiveness and safety of insulin glargine in combination with glimepiride treatment in daily practice in patients who failed premixed insulin with or without oral antidiabetic (OAD) regimen. Patients and methods This 6-month, prospective, multicenter, observational study conducted in Egypt included adult patients with type 2 diabetes mellitus on premix with or without OAD (glimepiride plus metformin), with glycated hemoglobin (HbA1c) greater than 8.5% and for whom the investigator decided to switch to insulin glargine in addition to glimepiride. Overall, three mandatory visits (baseline, 3 months, and 6 months) and seven phone calls were performed by the investigator for each eligible patient. Patients were assessed according to the value of HbA1c and fasting blood glucose (FBG). Results At the end of this study, the results showed effectiveness of combining insulin glargine plus glimepiride in reducing the mean baseline level of HbA1c% by 1.79 and 2.5% at visit 2 (week 12) and visit 3 (week 24), respectively (P 0.05). The mean 2-h postprandial blood glucose level was decreased significantly (P A total of 50 adverse events were reported by 41 patients during the study. The most frequently reported adverse event was hypoglycemia, which included 37 episodes reported by 31 patients, where nocturnal hypoglycemia was represented in 12 episodes, with percentage of 32.4%. Conclusion The results showed that a combination therapy of insulin glargine and glimepiride improved glycemic control in patients with type 2 diabetes mellitus, who failed premixed with or without OAD (glimepiride plus metformin). In addition, safety analysis showed high patient tolerability to glargine and glimepiride regimen.

Sustained glycaemic control and less nocturnal hypoglycaemia with insulin glargine 300 U/mL compared with glargine 100 U/mL in Japanese adults with type 1 diabetes (EDITION JP 1 randomised 12-month trial including 6-month extension)

AimsTo evaluate the efficacy and safety of insulin glargine 300U/mL (Gla-300) versus glargine 100U/mL (Gla-100) in adults with type 1 diabetes in Japan over 12months. MethodsEDITION JP 1 was a multicentre, randomised, open-label phase 3 study. Following a 6-month on-treatment period, participants continued to receive Gla-300 or Gla-100 once daily, plus mealtime insulin, over a 6-month open-label extension phase. HbA1c, hypoglycaemia, body weight and adverse events were assessed. ResultsOverall, 114/122 (93%) and 114/121 (94%) of participants in the Gla-300 and Gla-100 group, respectively, completed the 6-month extension phase. Glycaemic control was sustained in both groups up to month 12 (mean HbA1c: Gla-300, 7.9% [62mmol/mol]; Gla-100, 7.8% [62mmol/mol]). Annualised rates of hypoglycaemia were lower with Gla-300 versus Gla-100; significantly for nocturnal confirmed (<3.0mmol/L [<54mg/dL]) or severe hypoglycaemia (2.39 and 3.85 events per participant-year; rate ratio: 0.62 [0.39–0.97]). No between-treatment differences in mean body weight change or adverse events were observed. ConclusionOver 12months’ treatment, participants with type 1 diabetes receiving Gla-300 achieved sustained glycaemic control and experienced less nocturnal hypoglycaemia that was confirmed (<3.0mmol/L [<54mg/dL]) or severe compared with Gla-100, supporting the 6-month results.

Effectiveness of insulin glargine in type 2 diabetes mellitus patients failing glycaemic control with premixed insulin: Adriatic countries data meta-analysis.

Type 2 diabetes mellitus (T2DM) is a progressive disease, often requiring exogenous insulin therapy and treatment intensification. Despite new therapies, most patients do not reach the recommended HbA1c targets, among them a significant proportion of patients on premixed insulins. The aim was to summarize published data in Adriatic countries on effectiveness of insulin glargine based therapy in type 2 diabetic patients suboptimally controlled on premix insulin. A meta-analysis was carried out in major medical databases up to April 2014, focusing on Adriatic region. We searched observational studies with duration of at least 6 months, evaluating effectiveness and safety of insulin glargine (IGlar), in combination with OAD or bolus insulin in patients with T2 failing premixed insulin therapy. Outcomes included values of HbA1c, fasting blood glucose and two hours post-prandial glucose concentration as well as changes in body mass index after at least 6 months of study duration. Three prospective, observational, multicentric trials (698 patients in total) were included. The basal bolus regimen with glargine significantly reduced HbA1c (Mean Difference, MD=2.27, CI [1.76, 2.78]), fasting glucose (MD=5.15, CI [4.86, 5.44]) and 2-hours postprandial glucose concentration (MD=6.94, CI [6.53, 7.34]). No significant changes were found in BMI after switching from premixes to IGlar based treatment. Insulin glargine based therapy following premix failure is efficacious and safe option of type 2 diabetes treatment intensification.

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

Background: The aim of the study was to assess the real-life efficacy and safety of insulin glargine (Lantus ® , Sanofi) as a basal regimen in patients with type 2 diabetes mellitus (T2DM) who are poorly controlled with oral antidiabetic drugs (OADs) and/or other insulins. Methods: This observational, multicenter study was carried out in Morocco in 2011 and included 497 adult patients with T2DM and a baseline glycated hemoglobin (HbA1c) between 7.5% and 10.5% and for whom a basal regimen with insulin glargine was initiated. Two follow-up visits were scheduled at 12 and 26 weeks after starting treatment. The primary outcome target was HbA1c < 7%. Safety was assessed by the frequency of hypoglycemic episodes. Results: The target HbA1c level of < 7% was reached by 11.5% of patients after 3 months of insulin glargine treatment and 32% after 6 months. Mean HbA1c decreased significantly from 9.37±1.14% at baseline to 7.43±0.87% at 6 months (P < 0.001). Mean fasting blood glucose also decreased significantly from 237.5 ± 66.9 mg/dL at baseline to 129.5 ± 35.1 mg/dL at 6 months (P < 0.001). Approximately 12% of patients reported at least one hypoglycemic episode. No adverse event other than hypoglycemia was reported. Conclusions: This study shows that in a real-life setting, a basal regimen with insulin glargine significantly improves glycemic control in patients with T2DM who are inadequately controlled with OADs or other insulin regimens, with an acceptable hypoglycemia profile. J Endocrinol Metab. 2015;5(6):333-336 doi: http://dx.doi.org/10.14740/jem315w

Systematic review and meta-analysis of randomized clinical trials comparing efficacy and safety outcomes of insulin glargine with NPH insulin, premixed insulin preparations or with insulin detemir in type 2 diabetes mellitus.

AimsA variety of basal insulin preparations are used to treat patients with type 2 diabetes mellitus (T2DM). We aimed to summarize scientific evidence on relative efficacy and safety of insulin glargine (IGlar) and other insulins in T2DM.MethodsA systematic review was carried out in major medical databases up to December 2012. Relevant studies compared efficacy and safety of IGlar, added to oral drugs (OAD) or/and in combination with bolus insulin, with protamine insulin (NPH) or premixed insulin (MIX) in the same regimen, as well as with insulin detemir (IDet), in T2DM. Target HbA1c level without hypoglycemic events was considered the primary endpoint.ResultsTwenty eight RCTs involving 12,669 T2DM patients followed for 12–52 weeks were included in quantitative analysis. IGlar + OAD use was associated with higher probability of reaching target HbA1c level without hypoglycemia as compared to NPH + OAD (RR = 1.32 [1.09, 1.59]) or MIX without OAD (RR = 1.61 [1.22, 2.13]) and similar effect as IDet + OAD (RR = 1.07 [0.87, 1.33]) and MIX + OAD (RR = 1.09 [0.86, 1.38]). IGlar + OAD demonstrated significantly lower risk of symptomatic hypoglycemia as compared to NPH + OAD (RR = 0.89 [0.83, 0.96]), MIX + OAD (RR = 0.75 [0.68, 0.83]) and MIX without OAD(RR = 0.75 [0.68, 0.83]), but not with IDet + OAD (RR = 0.99 [0.90, 1.08]). In basal-bolus regimens, IGlar demonstrated similar proportion of T2DM patients achieving target HbA1c as compared to NPH (RR = 1.14 [0.91, 1.44]) but higher than MIX (RR = 1.26 [1.12, 1.42) or IDet (RR = 1.38 [1.11, 1.72]). The risk of severe hypoglycemia was lower in IGlar than in NPH (RR = 0.77 [0.63, 0.94]), with no differences in comparison with MIX (RR = 0.74 [0.46, 1.20]) and IDet (RR = 1.10 [0.54, 2.25]). IGlar + OAD has comparable safety profile to NPH, with less frequent adverse events leading to treatment discontinuation than MIX + OAD (RR = 0.41 [0.22, 0.76]) and IDet + OAD (RR = 0.40 [0.24, 0.69]). Also severe adverse reactions were less common for IGlar + OAD when compared to MIX + OAD (RR = 0.71 [0.52; 0.98]).ConclusionFor the majority of examined efficacy and safety outcomes, IGlar use in T2DM patients was superior or non-inferior to the alternative insulin treatment options.Electronic supplementary materialThe online version of this article (doi:10.1007/s00592-014-0698-4) contains supplementary material, which is available to authorized users.

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

Background: The aim of the study was to assess the real-life efficacy and safety of insulin glargine (Lantus ® , Sanofi) as a basal regimen in patients with type 2 diabetes mellitus (T2DM) who are poorly controlled with oral antidiabetic drugs (OADs) and/or other insulins. Methods: This observational, multicenter study was carried out in Morocco in 2011 and included 497 adult patients with T2DM and a baseline glycated hemoglobin (HbA1c) between 7.5% and 10.5% and for whom a basal regimen with insulin glargine was initiated. Two follow-up visits were scheduled at 12 and 26 weeks after starting treatment. The primary outcome target was HbA1c &lt; 7%. Safety was assessed by the frequency of hypoglycemic episodes. Results: The target HbA1c level of &lt; 7% was reached by 11.5% of patients after 3 months of insulin glargine treatment and 32% after 6 months. Mean HbA1c decreased significantly from 9.37±1.14% at baseline to 7.43±0.87% at 6 months (P &lt; 0.001). Mean fasting blood glucose also decreased significantly from 237.5 ± 66.9 mg/dL at baseline to 129.5 ± 35.1 mg/dL at 6 months (P &lt; 0.001). Approximately 12% of patients reported at least one hypoglycemic episode. No adverse event other than hypoglycemia was reported. Conclusions: This study shows that in a real-life setting, a basal regimen with insulin glargine significantly improves glycemic control in patients with T2DM who are inadequately controlled with OADs or other insulin regimens, with an acceptable hypoglycemia profile. J Endocrinol Metab. 2015;5(6):333-336 doi: http://dx.doi.org/10.14740/jem315w

Abstract 11898: Effects of Insulin Glargine on Left Ventricular Mass and Function in Patients With Dysglycemia

Introduction: Type 2 diabetes mellitus (T2DM) is associated with increased risk for left ventricular (LV) hypertrophy and heart failure (HF). Moreover, some drugs used to treat hyperglycaemia are associated with increased risk of HF. There are limited data on the effects of exogenous insulin on left ventricular mass (LVM) and function (LVF). Therefore, we evaluated the effects of insulin glargine on LVM and LVF in the echocardiographic substudy of the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial (funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784). Methods: Patients aged ≥ 50 years with dysglycemia (early T2DM, impaired glucose tolerance, or impaired fasting glucose) and with cardiovascular (CV) disease or CV risk factors were randomized to receive insulin glargine (with a target fasting blood glucose level of ≤95 mg per deciliter [5.3 mmol per liter]) or standard glycemic care. Echocardiograms were performed at baseline and after 3 years. Changes in LVM, LV ejection fraction (LVEF), wall motion score (WMS), LV end-diastolic and end-systolic volume (LVEDV and LVESV), E/A, and E/E’ were compared between the study groups using mixed effects modelling. Results: 564 patients aged 64 ± 8 years were evaluated; 30% were women, 84% had a history of hypertension and 32% of prior myocardial infarction. This is the largest reported study on the effects of exogenous insulin on LVM and LVF. There were no significant differences in the changes over time in LVM and LV systolic and diastolic function between the study groups (Table). Conclusions: In people with CV disease and/or CV risk factors and dysglycemia three years of treatment with insulin glargine has a neutral effect on LVM and on LV systolic and diastolic function. These findings support the CV safety of insulin glargine.

Research on the efficacy and safety of insulin glargine in different administration time for treatment of type 1 diabetes

Objective To explore the clinical efficacy and safety of insulin glargine in different administra-tion time for treatment of type 1 diabetes .Methods 50 patients with type 1 diabetes were given insulin aspart and in-sulin glargine treatment scheme , under the premise of not change insulin glargine dosage , delivery time of insulin glargine varied from 22：00 to 18：00,and fasting blood glucose（FBG）,2 hours postprandial blood glucose（2hPG）, blood glucose and occurrence of hypoglycemia before lunch , amount of insulin aspart were noted and compared between before and after the adjustment .Results After adjustment of insulin glargine′s medication time , patients′blood sugar before lunch adjusted to desired level ,FBG（7.28 ±2.13） mmol/L vs.（8.33 ±2.20） mmol/L,2hPG （8.61 ±2.59）mmol/L vs.（9.70 ±1.75） mmol/L decreased significantly after lunch compared with pre-adjustment （U=2.425,3.034,all P〈0.05）,2hPG after breakfast （8.27 ±2.02） mmol/L vs.（8.56 ±2.33） mmol/L and dinner 2hPG （9.54 ±1.55）mmol/L vs.（9.61 ±1.75）mmol/L without statistically significant difference （all P〉0.05）.Dosage of insulin aspart before breakfast reduced , and increased before lunch and dinner .Incidence of hypoglycemia before lunch significantly decreased （χ2 =4.105,5.005,all P〈0.05）.Conclusion Insulin glargine combined with insulin aspart in the treatment of type I diabetes ,with no change in insulin glargine dosage ,and delivery time changed from 22：00 to 18：00,which could reduce FBG ,reduce occurrence of hypoglycemia before lunch ,and stable in blood sugar controlling . Key words: Diabetes mellitus, type 1 ; Insulin glargine

The outcome of care in people with type 1 diabetes after switching to insulin glargine-based regimens in a real-life setting: a long-term observational study.

Different insulin preparations are used as basal insulins in type 1 diabetes. The aim of this study was to assess long-term efficacy and safety of insulin glargine after switching from other basal insulins in type 1 diabetes in a real-life setting. In the clinic's database, 87 subjects treated with glargine for >1year were identified. In all patients, HbA1c level, insulin doses, episodes of severe hypoglycaemia, diabetic complications, comorbidities, body mass index (BMI), blood pressure and concomitant medications' use were monitored throughout the entire follow-up period. During observation, lasting mean 61.9±27.6months HbA1c level decreased from 8.86±1.60% (73.3mmol/mol) to 8.25±1.40% (66.7mmol/mol), p<0.001. This improvement was maintained up to 8years. Frequency of severe hypoglycaemia was 6.24/100 patient-years. Total insulin requirement did not changed significantly. BMI increased from 23.57±2.90 to 24.52±3.46kg/m(2) (p<0.001). Significant weight gain (>5%) occurred in 30 subjects, while 10 patients lost weight. Mean systolic blood pressure (SBP) increased from 136.3±13.4 to 140.7±15.1mmHg (p=0.008), while diastolic blood pressure remained unchanged. Development or progression of diabetic complications was revealed in 11 subjects. Following switch from other basal insulins to insulin glargine in type 1 diabetic patients, glycaemic control significantly improved, with unchanged total insulin requirement and with low risk of severe hypoglycaemia. Weight gain and elevation of SBP observed in this study require special attention and educational efforts. In summary, insulin glargine can be recommended as an effective and safe basal insulin in type 1 diabetes in a real-life setting.

Evaluation of the Effectiveness and Safety of Basal Based Therapy with Insulin Glargine and Prandial Insulin in Patients with Type 2 Diabetes Poorly Controlled with Premixed Insulin

Abstract Introduction. Type 2 diabetes mellitus (T2DM) is a progressive disease, requiring treatment intensification and exogenous insulin therapy in many patients. The aim of the study was to evaluate the effectiveness and safety of insulin glargine in combination with prandial insulin in poorly controlled type 2 patients previously treated with premixed insulin. Methods. A total of 200 type 2 diabetic patients in Macedonia (male 37.5%; female 62.5%, aged 61.1±0.5 years) poorly controlled (HbA1c&gt;7%) were included in this observational multicenter prospective study. Before enrolment, all patients were treated with premixed insulin (88% with 2 and 12% with 3 injections per day, respectively). During the study, patients received once-daily glargine plus pre-prandial short-acting insulin analogues at investigators’ discretion. Primary end-point included percentage of patients achieving HbA1c &lt;7% at study end. In addition, changes in mean HbA1c and fasting plasma glucose (FPG) during the study duration as well as frequency of hypoglycaemic episodes were evaluated. Results. After 9 months of follow-up, 100 patients (50%) achieved target HbA1c &lt;7%. Mean HbA1c decreased from 9.5±1.5% at the beginning to 6.9±0.8% (p&lt;0.001) at study end and mean FPG decreased from 11.0±3.3 mmol/l to 6.1± 0.9 mmol/l (p&lt;0.001). 50.5% of the patients were treated with basal insulin in combination with OADs and 49.5% required addition of one or more prandial insulin injections. No episodes of severe hypoglycaemia were documented. Conclusions. Basal based insulin treatment with insulin glargine alone or in combination with prandial insulin improved glycaemic control in type 2 diabetics previously poorly controlled with premixed insulin with a low risk of hypoglycaemia and weight gain.