Daily Basal Insulin Dose Research Articles

IGlarLixi effectively reduces residual hyperglycaemia in Chinese people with type 2 diabetes on basal insulin: A post hoc analysis of the LixiLan-L-CN study.

To compare the effects of iGlarLixi versus insulin glargine 100 U/mL (iGlar) on residual hyperglycaemia in Chinese people with uncontrolled type 2 diabetes (T2D) on prior basal insulin (BI) therapy ± oral antidiabetic drugs in the LixiLan-L-CN study (NCT03798080). In this post hoc analysis, residual hyperglycaemia (i.e. HbA1c ≥ 7.0% [≥ 53 mmol/mol] and fasting plasma glucose [FPG] < 7.0 mmol/L) were assessed over 30 weeks. Outcomes were assessed at week 30 in participants with baseline residual hyperglycaemia, including changes from baseline in HbA1c, FPG, 2-hour postprandial glucose (PPG) and daily BI dose, the proportion of participants with HbA1c less than 7.0% (< 53 mmol/mol) and FPG less than 7.0 mmol/L and the incidence of hypoglycaemia. Of 421 participants, 124 (29.5%) had baseline residual hyperglycaemia (iGlarLixi, n = 64 [31.7%]; iGlar, n = 60 [29.1%]). At week 30, the residual hyperglycaemia rate decreased to 7.0% with iGlarLixi and increased to 43.3% with iGlar. Among participants with baseline residual hyperglycaemia, a greater proportion achieved both HbA1c and FPG targets at week 30 with iGlarLixi versus iGlar (43.8% vs. 16.7%), and iGlarLixi provided greater reductions in HbA1c (least squares mean [LSM] difference, -0.9% [-9.4 mmol/mol]) and 2-hour PPG (LSM difference, -4.7 mmol/L; both P < .001). Daily BI dose and incidence of hypoglycaemia were similar in the two groups. The findings of this post hoc analysis suggest that iGlarLixi had greater benefits than iGlar in reducing the rate of residual hyperglycaemia over 30 weeks in Chinese people with suboptimally controlled T2D on prior BI-based therapy.

The Effectiveness of an App (Insulia) in Recommending Basal Insulin Doses for French Patients With Type 2 Diabetes Mellitus: Longitudinal Observational Study.

For patients with type 2 diabetes (T2D), calculating the daily dose of basal insulin may be challenging. Insulia is a digital remote monitoring solution that uses clinical algorithms to recommend basal insulin doses. A predecessor device was evaluated in the TeleDiab-2 randomized controlled trial, showing that a higher percentage of patients using the app achieved their target fasting blood glucose (FBG) level compared to the control group, and insulin doses were adjusted to higher levels without hypoglycemia. This study aims to analyze how the glycemic control of Insulia users has evolved when using the app in a real-life setting in France. A retrospective observational analysis of data collected through the device in adult French patients with T2D treated with basal insulin and oral antihyperglycemic agents using the system for ≥6 months was conducted. Analyses were descriptive and distinguished the results in a subpopulation of regular and compliant users of the app. Glycemic outcomes were estimated considering the percentage of patients who achieved their individualized FBG target between 5.5 and 6 months following the initiation of device use, the frequency of hypoglycemia resulting in a treatment change over the 6-month period of exposure, and the evolution of the average hemoglobin A1c (HbA1c) level over the same period. Of the 484 users, 373 (77.1%) performed at least one dose calculation. A total of 221 (59.2%) users were men. When app use started, the mean age, BMI, HbA1c, and basal insulin dose were 55.8 (SD 11.9) years, 30.6 (SD 5.9) kg/m2, 10.1% (SD 2.0%), and 25.5 (SD 15.8) IU/day, respectively. Over a median use duration of 5.0 (95% CI 3.8-5.7) months, patients used the system 5.8 (SD 1.6) times per week on average, and 73.4% of their injected doses were consistent with the app's suggested doses. Among regular and compliant user patients (n=91, ≥5 measurements/week and ≥80% adherence to calculated doses), 60% (55/91) achieved the FBG target (±5%) at 6 months (5.5-6 months) versus 51.5% (145/282) of the other patients (P=.15). There was an increase in the proportion of patients achieving their target FBG for regular and compliant users (+1.86% every 2 weeks) without clear improvement in other patients. A logistic model did not identify the variables that were significantly associated with this outcome among regular and compliant users. In the overall population, the incidence of reported hypoglycemia decreased simultaneously (-0.16%/month). Among 82 patients, the mean HbA1c decreased from 9.9% to 7.2% at 6 months. An improvement in glycemic control as measured by the percentage of patients reaching their FBG individualized target range without increasing hypoglycemic risk was observed in patients using the Insulia app, especially among regular users following the dose recommendations of the algorithm.

NPH Insulin Versus Insulin Glargine Versus NPH Insulin Plus Insulin Glargine for the Treatment of Dexamethasone-Induced Hyperglycemia in Patients With COVID-19: A Retrospective Cohort Study.

Dexamethasone use in patients hospitalized with COVID-19 significantly reduces mortality; however, it commonly results in hyperglycemia. Optimal treatment of dexamethasone-induced hyperglycemia is not well established. The study purpose was to assess the difference in blood glucose (BG) control between insulin glargine, neutral protamine hagedorn (NPH) insulin, and insulin glargine plus NPH insulin for dexamethasone-induced hyperglycemia in patients with type 2 diabetes (T2DM) and COVID-19 infection. This retrospective study was conducted in adult inpatients with T2DM and COVID-19 infection who received 6 mg of dexamethasone once daily and insulin during the 5-day study period. The primary outcome was the difference in mean point-of-care (POC) BG levels between study insulins. Secondary outcomes included the incidence of hyperglycemia and hypoglycemia, length of stay, and the percent difference between the mean daily inpatient and home basal insulin doses (for patients who were receiving basal insulin prior to admission in the insulin glargine and insulin glargine and NPH insulin groups only). Ninety-six patients were included in the analysis (67 insulin glargine, 10 NPH insulin, and 19 insulin glargine plus NPH insulin). The difference in mean POC BG level was not different among groups (254 ± 60 mg/dL vs 234 ± 39 mg/dL vs 250 ± 51 mg/dL, respectively; P = 0.548). There were no significant differences in the secondary outcomes. No difference in the mean POC BG level was observed. Dexamethasone-induced hyperglycemia was poorly controlled in patients with T2DM and COVID-19 infection.

The use of long-acting insulin degludec in adult patients with type 2 diabetes mellitus in real clinical practice in Russia

BACKGROUND: Effective glycaemic control remains the most important task in managing the risks of Diabetes type 2 complications development. In this regard, the choice of insulin preparations with minimal variability of action is of utmost importance since this approach allows achieving the maximum treatment effectiveness and adequate safety level.AIM: The aim of this study was to investigate insulin degludec treatment effect on glycemic control in adult patients with Diabetes Mellitus (DM) type 2 in a real-world clinical setting in the Russian Federation.MATERIALS AND METHODS: The open prospective study was conducted in 2020–2021 in 35 clinical centers in 31 cities of the Russian Federation. The study included adult patients with type 2 DM treated according to Russian routine clinical practice. The prospective follow-up period was 26 weeks. The main study endpoints were changes in HbA1c level, fasting plasma glucose, insulin daily doses, number, and characteristics of different types of hypoglycaemia episodes and adverse events (AEs), and patient preferences compared to previous treatment.RESULTS: The study enrolled 494 patients. By the end of follow-up period:The mean HbA1c decrease was 1.6% (p&lt;0.0001).Fasting plasma glucose level decreased by 3.4 mmol/L (p&lt;0.0001).Daily basal and prandial insulin doses decreased by 1.6 IU/day (p&lt;0.0001) and 2.1 IU/day (p&lt;0.01), respectively.Severe episodes of hypoglycemia did not occur, while the incidence of nonsevere episodes decreased significantly.76 patients (15.4%) had 105 AEs, of which 41 (in 33 patients, 6.7%) were serious.COVID-19 was the most frequent AE reported in 21 patients (4.3%).Only in one case insulin degludec was withdrawn due to the patient’s pregnancy and the AEs that arose from it.Most patients (98.6%) preferred insulin degludec to previous treatment.CONCLUSION: The study demonstrated a statistically significant improvement in glycemic control, accompanied by basal insulin dose decrease combined with the absence of severe episodes of hypoglycemia, and significant decrease of nonsevere episodes (total and nocturnal). These results led to a large proportion of patients wanting to continue insulin degludec treatment preferring the medicine over previous treatment.

LBSUN207 Efficacy And Safety Of Degludec U100 Versus Glargine U300 For The Hospital Management Of Patients With Type 2 Diabetes: A Prospective, Open-label, Non-inferiority Randomized Controlled Trial

Abstract Aims No head-to-head comparisons of two ultra-long acting insulins, degludec-100 and glargine-300, have been reported in the inpatient setting. We compared the efficacy and safety of these two insulins for the hospital management of patients with type 2 diabetes (T2D). Methods This target-to-treat, randomized controlled trial enrolled patients with T2D admitted for coronary artery bypass graft surgery (CABG). On the day of transition (day 2 of surgery) from intravenous insulin infusion to multiple subcutaneous insulin injections, patients were randomly assigned (1: 1) to receive a basal-bolus regimen using either degludec-100 or glargine-300 as basal and glulisine as bolus before meals. Insulin was adjusted daily to maintain a fasting blood glucose (BG) &amp;lt;140 mg/dL and pre-meal BG &amp;lt;180, while avoiding hypoglycemia &amp;lt;70 mg/dL. The primary endpoint was non-inferiority in mean differences between groups in their daily BG concentrations measured during the duration of the hospital stay and a week post-discharge, up to 12 days (point-of-care measurements, pre-breakfast, pre-lunch, pre-dinner and nighttime [0300 hours]: non-inferiority was deemed a difference &amp;lt;18 mg/dL). The major safety outcome was the occurrence of hypoglycemia. Secondary outcome measures included mean differences between groups in their daily BG concentrations, time in range (TIR, %), time below range (TBR, %), and time above range(TAR, %), as assessed by continuous glucose monitoring system (CGMS, n = 142). Results Between October 12, 2021, and February 10, 2022, 324 consecutive patients with T2D undergoing CABG were screened, 239 patients were randomly assigned to treatment; 122 to degludec-100 group and 117 to glargine-300 group. The mean daily BG concentration in the degludec-100 group (157 mg/dL [SD 25]) was not inferior to that in the glargine-300 group (162 mg/dL [SD 24]), with a mean BG difference of -5 mg/dL (95% CI, -11 to 2, p = 0.18). There were no differences between degludec-100 group and glargine-300 group in mean percentage of readings within target BG of 70-180 mg/dL (74% ± 29% vs. 73% ± 30%, p = 0.19), daily basal insulin dose (19 ± 8 vs. 21 ± 9 units/day, p = 0.13), length of stay in hospital (median [IQR]: 9 [8-11] vs. 9 [8-11] days, p = 0.51), or hospital complications (21.3% vs. 21.4%, p = 0.99). There were no differences in the proportion of patients with BG &amp;lt;70 mg/dL (15.6% vs. 23.1%, p = 0.14) or &amp;lt;54 mg/dL (1.6% vs. 4.3%, p = 0.226) between degludec-100 and glargine-300 groups. There was no difference between groups in mean daily BG concentrations (141 ± 26 vs. 142 ± 28 mg/dL, p = 0.88), TIR (72. 0% vs. 72.9%, p = 0.71), TBR (5.9% vs. 5.2%, p = 0.50) and TAR (22. 0% vs. 21.8%, 0.93) as assessed by CGMS. Conclusions Treatment with degludec-100 as a basal insulin is as effective and safe as glargine-300 for the hospital management of patients with T2D admitted to cardiac surgery service in the non-intensive care unit setting. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

Comparison of three insulin bolus calculators to increase time in range of glycemia in a group of poorly controlled adults Type 1 diabetes in a Brazilian public health service

BackgroundA main factor contributing to insufficient glycemic control, during basal/bolus insulin therapy, is poor self-management bolus. Insulin bolus administration frequency is strongly associated with glycated hemoglobin (A1c) in Type 1 Diabetes (T1D). In the present study, we analyzed the performance of two-bolus calculator’s software that could be accessible to T1D patients from a Public Health Service to improve glycemic time in range (TIR) and A1c.MethodsThis prospective, controlled, randomized, parallel intervention clinical trial was carried out with 111 T1D participants on basal/bolus therapy [multiple daily insulin injections (MDI) or subcutaneous infusion pump (CSII)] with basal A1c ≥ 8.5% for 24 weeks. Patients were divided into 3 groups: 2 interventions: COMBO® (bolus calculator) and GLIC (mobile application) and 1 control (CSII group). Anthropometrics and metabolic variables were assessed on basal, 3 and 6 months of follow-up.ResultsTIR was increased in 9.42% in COMBO group (29 ± 12% to 38.9 ± 12.7%; p < 0.001) in 8.39% in the GLIC® group (28 ± 15% to 36.6 ± 15.1%; p < 0.001) while remained stable in CSII group (40 ± 11% to 39.3 ± 10.3%). A1c decrease in 1.08% (p < 0.001), 0.64% (p < 0.001) and 0.38% (p = 0.01) at 6 months in relation to basal in the COMBO, GLIC and CSII respectively. Daily basal insulin dose was reduced by 8.8% (p = 0.01) in the COMBO group.ConclusionThe COMBO and a mobile applicative (GLIC) bolus calculator had a similar and a good performance to optimize the intensive insulin treatment of T1D in the public health system with increase in the TIR and reduction in A1C without increase hypoglycemia prevalence.

Predictors of time in target glucose range in real-world users of the MiniMed 780G system.

Automated insulin delivery systems have improved glycaemic control in people with type 1 diabetes mellitus. The analysis investigated predictors of improved sensor glucose time-in-range (TIR; 70-180 mg/dl) based on real-world use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. Data uploaded by MiniMed 780G system users from August 2020-July 2021 were analysed using univariate and multivariable models to identify baseline, demographic and system use characteristics associated with TIR after AHCL initiation (post-AHCL). System settings associated with improved TIR post-AHCL were identified and their impact on time below range (TBR, <70 mg/dl) post-AHCL was explored. In total, 12 870 users were included, of which 2977 had baseline sensor glucose data. Baseline TIR and time in AHCL (defined as the percentage of time the system was in Auto-mode) were positively associated with TIR post-AHCL with larger values predicting greater mean TIR post-AHCL. Characteristics inversely associated with TIR post-AHCL included the percentage of daily basal insulin dose, daily autocorrection dose, number of daily AHCL exits triggered by the system and number of daily alarms, wherein larger values of these characteristics predicted lower mean TIR post-AHCL. System settings that predicted the largest mean TIR post-AHCL were active insulin time of 2 h and glucose target of 100 mg/dl. Active insulin time was not associated with TBR post-AHCL. Modifiable factors, including optimized pump settings, can allow users to achieve glycaemic targets with >80% TIR. The findings from this analysis will potentially guide the optimal use of the MiniMed 780G system and facilitate meaningful improvements in safe glycaemic control.

The Impact of Adding Prandial Insulin to a Basal Based Regimen with Insulin Glargine in Type 2 Diabetic Patients.

Background: Type 2 diabetes (T2D) is a progressive disease that should be managed with insulin in case of oral glucose lowering drugs (OGLDs) failure. If basal insulin is not sufficient, rapid acting insulin will be added before the largest meal. We assessed the impact of adding one prandial insulin to a basal based regimen and insulin glargine in patients with type 2 diabetes to measure the percentage of subjects achieving the HbA1c target by the end of 24 weeks of treatment in routine clinical practice. Methods: This study was a 24-week observational study of patients with T2D not adequately controlled with OGLDs and basal insulin, for whom the physician had decided to initiate prandial insulin. The study endpoint was assessed at visit 1 (baseline), visit 2 at week 12 (±1 week) and visit 3 at week 24 (±1 week). The percentage of patients who achieved HbA1c targets was assessed at week 24. Statistical analyses were performed using IBM SPSS for Windows v 19 (IBM, Armonk, New York, USA). Logistic regression analysis was used to detect predicting factors of achieving the HbA1c target by week 24. P<0.05 was considered as significant level. Results : Four hundred and eighteen patients with a mean±SD age of 56.24±9.85 years and a mean±SD duration of diabetes of 12.50±7.16 years were included. The median total daily dose of basal insulin was 24 units, while prandial insulin was started with 6 (4, 10) U/day, titrating up to 10 (8, 18) U/day at week 24. The daily dose of prandial insulin was the only factor that could significantly predict achieving targeted HbA1c by week 24 [OR: 1.04; 95% CI: 1.007,1.079; p-value: 0.019]. At week 24, 96 (22.9%) subjects achieved the HbA1c target with one prandial insulin. Conclusion : The results of our study suggest that “basal plus therapy” can lead to good glycemic control with a low risk of hypoglycemia and weight gain in patients with type 2 diabetes.

Basal insulin requirement in patients with type 1 diabetes depends on the age and body mass index.

Aims/IntroductionTo investigate the basal insulin requirement in patients with type 1 diabetes who are on multiple daily injections (MDI) and to assess the patient characteristics that affect the percent of total daily basal insulin dose to the total daily insulin dose (%TBD/TDD).Materials and MethodsThe subjects of this study were 67 inpatients with type 1 diabetes who were served diabetic meals of 25–30 kcal/kg standard body weight during several weeks of hospitalization. The basal insulin requirement was adjusted to keep the blood glucose level from bedtime to before breakfast within a 30 mg/dL difference. The bolus insulin dose before the meal was adjusted to keep the blood glucose level below 140 and 200 mg/dL before and 2 h after each meal, respectively. The total daily insulin dose (TDD), the percent of total daily basal insulin dose (TBD) to TDD (%TBD/TDD), and clinical characteristics were collected.ResultsThe median (Q1, Q3) of TDD was 33.0 (26.0, 49.0) units, and the %TBD/TDD was 24.1 ± 9.8%. The %TBD/TDD was positively correlated with the body mass index (BMI) and negatively correlated with the age at the onset and at the examination according to a univariate analysis. However, the %TBD/TDD was dependent on the BMI (β = 0.340, P = 0.004) and the age at examination (β = −0.288, P = 0.012) according to the multiple regression analysis.ConclusionsThe average %TBD/TDD in patients with type 1 diabetes on MDI was approximately 24% under inpatient conditions. The basal insulin requirement was dependent on the BMI and the age at examination.

Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial

People with type 1 diabetes who use continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) often remove their pump before extended periods of exercise, but this approach might result in reduced glycaemic control and increased risk of hyperglycaemia and ketogenesis. We aimed to assess the efficacy and safety of a hybrid approach, in which basal insulin delivery was divided between CSII and a daily injection of insulin degludec. In this single-centre, open-label, proof-of-concept, randomised crossover trial done at the LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII. Participants were randomly assigned (1:1) by use of a computer-generated sequence to one of two sequences of either usual CSII, involving the continuation of the participant's usual CSII regimen, followed by crossover to hybrid CSII, in which the delivery of the participant's usual daily basal insulin dose was split (50% delivered by CSII and 50% delivered by a once-daily morning injection of 100 U/mL insulin degludec), or the opposite sequence (ie, hybrid CSII followed by crossover to usual CSII). Treatment was not masked to the investigators or participants. For each intervention, participants completed a moderate-intensity and a high-intensity in-clinic exercise session in the first week, followed by four high-intensity and two moderate-intensity home-based exercise sessions in the subsequent 3 weeks. Insulin pumps were suspended or disconnected 60 min before exercise and reconnected immediately after exercise during both treatment regimens. The coprimary outcomes were: (1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose after moderate-intensity exercise, measured by continuous glucose monitoring in the 6-h period from the start of the high-intensity and moderate-intensity in-clinic exercise sessions. Outcomes were assessed in a modified intention-to-treat population that included all participants who started both intervention phases and completed all of the in-clinic exercise visits. This trial is registered with ClinicalTrials.gov, NCT03838783, and is complete. Between May 15, 2018, and March 5, 2019, we assessed 43 patients for eligibility, of whom 31 were randomly assigned to receive the usual CSII regimen (n=14) or hybrid CSII regimen (n=17) in the first phase (before crossover). The analysis population consisted of 24 participants who completed both study phases. Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]). Participants on the hybrid CSII regimen also showed a higher time in blood glucose range of 4-10 mmol/L during home-based exercise sessions (mean difference 23 min [95% CI -1 to 46], p=0·055), with significantly lower time spent in hyperglycaemia than participants on the usual CSII regimen (mean difference 25 min [2-48], p=0·04). These exploratory outcomes also showed no significant difference in the amount of time spent in hypoglycaemia, nor the number of hypoglycaemic events, between the two interventions. There were three study-related adverse events reported with the usual CSII regimen (two hypotension events and one nausea event) and four with the hybrid CSII regimen (two hypotension events and two nausea events). A hybrid regimen of injected insulin degludec and CSII (with pump removal during exercise) appears to be safe and effective in adults with type 1 diabetes who exercise regularly. This approach could offer improved glycaemic control immediately after exercise and should be further assessed in a larger-scale randomised trial. Novo Nordisk.

The Effect of Type and Daily Doses of Insulin to Treatment Success in Type 2 Diabetes Patients who are Receiving Basal-bolus Insulin Therapy.

Objectives:The present study aims to compare different types of insulin concerning treatment success and insulin dose requirement in type 2 diabetes patients who were receiving basal-bolus insulin therapy and to evaluate the causes of treatment failure despite high doses of insulin.Methods:In our retrospective study, 198 type 2 diabetes patients who were receiving basal-bolus insulin therapy included. Patients were divided into three groups according to the insulin types (Group 1: short and long-acting analogue insulin users (n=83), Group 2: short and long-acting human regular insulin users (n=58), Group 3: human regular insulin + long-acting analogue insulin users (57)). Demographic data and daily insulin doses were recorded from the patient follow-up files. These data and the rates of achievement of the target HbA1c levels were also compared between groups. In addition, insulin doses of the patients whose glycemic targets could and could not be achieved were compared.Results:In this study, 123 (62.1%) of the 198 patients were female and 65 (47.9 %) were male. The mean age of the three groups was 55.81±8.1, 58.3±8.9, 58.3±8.8, respectively. HbA1C values were 8.72±1.65% in group 1, 9.0±1.98% in group 2 and 9.05±2.24% in group 3. The rates of achievement HbA1c value below 7% were 27.7% in analogue insulin group, 25.9% human regular insulin group and 31.6% in regular + analogue insulin group (p >0.05). There were no significant differences in daily basal and bolus insulin doses, total daily and per kg insulin doses and basal-bolus rates between groups. Higher total daily insulin doses were determined in patients who could not achieve target glycemic values than achieved it in group 1 and 2. Higher basal insulin doses were determined in patients who could not achieve target glycemic values than could achieved it in group 3.Conclusion:In our study, in which we did not find any significant difference in the dose analysis between analogue and regular insulin, the findings showed that high insulin doses might not be sufficient for glycemic control. The underlying causes should be investigated and correctible reasons should be eliminated in these patients.

Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naïve people with type 2 diabetes: The EDITION AP randomized controlled trial.

AimTo compare the efficacy and safety of Gla‐300 versus Gla‐100 in insulin‐naïve people with type 2 diabetes in Asia Pacific.Materials and MethodsIn this open‐label, randomized, active‐controlled, 26‐week study, insulin‐naïve participants with type 2 diabetes inadequately controlled with non‐insulin antihyperglycaemic drugs were randomized (2:1) to Gla‐300 or Gla‐100. The initial daily dose of basal insulin was 0.2 U/kg and was adjusted at least weekly for 8–12 weeks to a target fasting self‐monitored plasma glucose (SMPG) of 4.4–5.6 mmol/L.ResultsOf the 604 participants randomized, 570 (Gla‐300, n = 375; Gla‐100, n = 195) completed the study. Non‐inferiority of Gla‐300 versus Gla‐100 in HbA1c reduction from baseline to week 26 was confirmed. In the Gla‐300 and Gla‐100 groups, 51.1% and 52.2% of participants achieved the HbA1c target of <7.0% (rate ratio [95% CI]: 0.98 [0.84 to 1.14]) and 19.1% and 21.9% achieved the target without hypoglycaemia during the last 12 weeks of treatment (rate ratio [95% CI]: 0.87 [0.63 to 1.20]). Changes in fasting plasma glucose and 24‐hour average eight‐point SMPG were comparable between groups. Incidence of hypoglycaemia at any time of day was similar between treatment groups at week 26, but incidence of any nocturnal hypoglycaemia was numerically lower with Gla‐300 than Gla‐100 over the initial 12‐week titration period and 26‐week on‐treatment period. Rates of adverse events were similar between groups and low for serious adverse events.ConclusionsGlycaemic control of Gla‐300 is non‐inferior to Gla‐100 with a similar or lower incidence and proportion of hypoglycaemia in people with type 2 diabetes in Asia Pacific, reinforcing the results in the global EDITION programme.

Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.

AimsBoth fasting (FPG) and postprandial plasma glucose (PPG) contribute to HbA1c levels. We investigated the relationship between achievement of American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) recommended FPG and/or PPG targets and glycaemic efficacy outcomes in two trials.MethodsIn this post hoc analysis, data from participants with Type 2 diabetes in the phase 3 LixiLan‐O (NCT 02058147) and LixiLan‐L (NCT 02058160) trials were evaluated to compare the relationship between achievement of society‐recommended FPG and/or PPG targets and efficacy (HbA1c change, HbA1c goal attainment, weight change) and safety outcomes in the treatment groups.ResultsAcross treatment arms, iGlarLixi achieved the highest proportion of participants meeting both ADA‐ and AACE‐recommended FPG and PPG targets at study end in both trials. A higher proportion of participants in the iGlarLixi (fixed‐ratio combination of insulin glargine and lixisenatide) vs. insulin glargine alone or lixisenatide alone treatment arms achieved HbA1c goals (P < 0.001 for overall comparisons), irrespective of ADA‐ or AACE‐defined targets. Hypoglycaemia rates [any, documented symptomatic (plasma glucose ≤ 3.9 mmol/l), and clinically important (plasma glucose < 3.0 mmol/l)] were low across all groups. Participants treated with iGlarLixi tended to show weight loss or less weight gain compared with participants receiving insulin glargine alone. No differences were observed in average daily basal insulin dose at week 30 between the two treatment arms or across the different FPG and PPG target groups.ConclusionInsulin glargine and lixisenatide as a fixed‐ratio combination resulted in more participants reaching both FPG and PPG targets, leading to better HbA1c target attainment.

Proportion of Basal to Total Insulin Dose Is Associated with Metabolic Control, Body Mass Index, and Treatment Modality in Children with Type 1 Diabetes—A Cross-Sectional Study with Data from the International SWEET Registry

To investigate in a large population the proportion of daily basal insulin dose (BD) to daily total insulin dose (TD) (BD/TD) and its association with glycated hemoglobin A1c (HbA1c),body mass index (BMI)- SDS, and treatment modality in children with type 1 diabetes. Cross-sectional study in subjects with type 1 diabetes, age ≤18years, and ≥2years of diabetes duration, registered in the international multicenter Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference registry in March 2018. Variables included region, sex, age, diabetes duration, treatment modality (multiple daily injections [MDI] or continuous subcutaneous insulin infusion [CSII]), self-monitoring blood glucose, HbA1c, BD/TD, and BMI-SDS. BMI was converted to BMI-SDS using World Health Organization charts as reference. Hierarchic linear regression models were applied with adjustment for age, sex, and diabetes duration. A total of 19 687 children with type 1 diabetes (49% female, 49% CSII users) with median age 14.8 (11.5; 17.2) years and diabetes duration 6.0 (3.9; 9.0) years were included. HbA1c was 63 (55; 74) mmol/mol (7.9 [7.2; 8.9]%), and BMI-SDS 0.55 (-0.13; 1.21). Unadjusted, a lower BD/TD was associated with lower HbA1c, male sex, younger age, shorter diabetes duration, lower BMI-SDS, higher numbers of self-monitoring blood glucose and CSII (all P<.01). After adjustment for confounders, lower BD/TD was associated with lower HbA1c (P<.01) and lower BMI-SDS (P<.01) in children on CSII, but not on MDI. Lower BD/TD is positively associated with lower HbA1c and lower BMI-SDS in children with type 1 diabetes on CSII. It remains to be investigated in a prospective study whether reducing BD/TD insulin will improve metabolic control and normalize body weight in children with type 1 diabetes.

Addition of Basal Insulin to Oral Antidiabetic Agents in Patients with Inadequately Controlled Type 2 Diabetes Leads to Improved HbA1c Levels: Metabolic Control, Frequency of Hypoglycemia, and Insulin Titration Analysis as Results of a Prospective Observational Study (BALI Study).

IntroductionDespite the continuously growing number of therapeutic options for patients with type 2 diabetes mellitus (T2DM), a large percentage of these individuals fail to achieve their glycated hemoglobin (HbA1c) target. The aim of this study was to determine the change in metabolic control in insulin-naïve T2DM patients inadequately controlled with oral antidiabetic drugs (OADs) at 6 months after initiating basal insulin treatment as add-on to existing OADs.MethodsThis was a non-interventional prospective study conducted from June 2013 to December 2014 in 137 centers in the Czech Republic under routine clinical practice conditions. Adult patients whose diabetes was uncontrolled on their current OAD treatment (HbA1c ≥ 53 mmol/mol; Diabetes Control and Complications Trial [DCCT]-HbA1c 7%) and whose physician had decided to initiate treatment on a basal insulin regimen were documented over a 6-month period beginning from the time of initiation of basal insulin treatment.ResultsOverall, 1426 T2DM patients were included in the study, of whom 53% were male. The mean age of the study population was 63.8 ± 10.1 years, mean body mass index was 31.5 ± 5.3 kg/m2, and mean duration of diabetes was 10.2 ± 5.3 years. At the 6-month follow-up, the target HbA1c level of 53 mmol/mol (DCCT < 7%) was achieved by 18% of patients. The mean HbA1c overall had decreased from 77.2 ± 15.1 mmol/mol (DCCT 9.21 ± 1.38%) at baseline to 63.2 ± 12.5 mmol/mol (DCCT 7.93 ± 1.14 %) at the 6-month follow-up. This difference was significant at p < 0.001. The largest mean reduction in HbA1c, i.e., 20.9 mmol/mol (DCCT 2.4 %) was observed in the group of patients with a baseline HbA1c of ≥ 9%. The mean daily basal insulin dose at 6 months was 18.8 ± 8.9 units. Symptomatic hypoglycemia was reported in 12.3% of patients, of those only one patient (0.1%) suffered from severe hypoglycemia.ConclusionThe addition of basal insulin to the therapeutic regimen of insulin-naïve T2DM on OAD treatment resulted in an improved metabolic control of diabetes after 6 months of treatment. However, most patients did not achieve their HbA1c target, probably also due to inadequate titration of basal insulin.FundingSanofi, Czech Republic.

A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA).

AimTo conduct an open‐label study to provide UK real‐world evidence regarding the use of insulin glargine 300 units/ml (U300) in people with Type 1 diabetes mellitus.MethodsPeople with Type 1 diabetes who had been prescribed U300 ≥6 months before data collection and had HbA1c levels recorded within 3 months prior to U300 (baseline) were included. The primary endpoint was change in HbA1c from baseline to month 6 after U300 initiation. Other endpoints included number of documented hypoglycaemic and diabetic ketoacidosis episodes, and change in daily basal insulin dose.ResultsA total of 298 people with Type 1 diabetes were included [mean age 42.1 years, mean HbA1c 79 mmol/mol (9.4%)]. After U300 initiation, the mean reduction in HbA1c from baseline to month 6 was –4 mmol/mol (–0.4%; P<0.001; n=188). The total daily basal insulin dose at 6 months was 1.3 units higher than at the time of U300 initiation (P<0.001; n=275) but was not significantly different from the prior basal insulin dose. There was no clinically significant difference in weight between baseline and month 6 [mean difference +0.7 kg, 95% CI –0.1, 1.5; P=0.084; n=115). During the 6 months before and after U300 initiation, severe hypoglycaemic episodes were documented for 6/298 and 4/298 participants. Diabetic ketoacidosis episodes requiring Accident and Emergency department visits or hospitalization were documented for 4/298 and 6/298 participants, before and after U300 initiation, respectively.ConclusionsIn people with Type 1 diabetes, a change in basal insulin to U300 was associated with clinically and statistically significant HbA1c improvements, without significant changes in basal insulin dose and weight. Documented severe hypoglycaemia episodes and diabetic ketoacidosis requiring Accident and Emergency department visits or hospitalization were low and similar before and after U300 initiation.

Daily dose of basal insulin in a population of obese diabetic women

Aim: The aim of our study is to determine the average daily dose of basal insulin in a population of obese diabetic women.

Achievement of Individualized HbA1c Targets with Self- vs. Physician-Led Titration of Basal Insulin (BI) in People with Type 2 Diabetes (T2DM), Newly or Recently Initiated on BI—Results from the DUNE Real-World Study

DUNE was a 12-week, prospective, observational study of 3139 adults with T2DM, newly (at enrollment) or recently (&amp;lt;12 months) initiated on BI. We evaluated the achievement of individualized HbA1c targets at 12 weeks according to self- vs. physician-led insulin titration. Irrespective of titration method, the proportion of participants who achieved their individualized HbA1c target at week 12 was &amp;lt;30% in both the newly- and recently- initiated BI groups (Table). For both titration groups, there were comparable improvements in fasting plasma glucose from baseline and similar incidence of hypoglycemia. Increase in total daily BI dose for self- vs. physician-led titration in the recently initiated BI group was 4.85 vs. 4.91 U, respectively, while in newly initiated individuals it was 9.68 vs. 7.77 U, respectively. Most participants who were self-titrating did so every 1-3 days, compared with no more frequently than every week for most participants who had physician-led titration. In all groups, the most frequently utilized dose increment was 2 U. The inability of most participants to achieve their target HbA1c in a real-world scenario, irrespective of the method of titration, warrants further investigation. Disclosure L. Berard: Other Relationship; Self; Abbott, Becton, Dickinson and Company, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi, Montmed Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., LifeScan Canada. Consultant; Self; Ascensia Diabetes Care. Other Relationship; Self; Novo Nordisk Inc., Merck &amp; Co., Inc. D. Mauricio: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; Eli Lilly and Company, GlaxoSmithKline plc.. Research Support; Self; GlaxoSmithKline plc.. Advisory Panel; Self; Janssen-Cilag Pty Limited. Speaker's Bureau; Self; Merck Sharp &amp; Dohme Corp.. Board Member; Self; Merck Sharp &amp; Dohme Corp.. Research Support; Self; Merck Sharp &amp; Dohme Corp.. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Sanofi. Board Member; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Sanofi. K. Khunti: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Sanofi-Aventis, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S. Consultant; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Takeda Development Centre Europe Ltd., Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novartis AG, Sanofi-Aventis, Pfizer Inc.. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Takeda Development Centre Europe Ltd., Servier. Research Support; Self; Novo Nordisk A/S. Consultant; Self; Pfizer Inc.. Research Support; Self; Novo Nordisk A/S. D.R. Franco: Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Sanofi, Eli Lilly and Company. Speaker's Bureau; Self; Abbott. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. C. Candelas: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. R. Perfetti: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Sanofi US, Novo Nordisk Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; American Diabetes Association.

Improved Glycemic Control Achieved by Switching to Insulin Degludec in Insulin-Treated Patients with Type 2 Diabetes in a Real-World Setting: a Non-interventional, Retrospective Cohort Study.

IntroductionRetrospective cohort study evaluating the clinical effectiveness of insulin degludec (IDeg) in insulin-treated patients with type 2 diabetes switching from other insulins to IDeg in a real-world setting.MethodsData were drawn from the Maccabi Health Management Organization in Israel and included patients treated with IDeg between 1 September 2014 and 29 February 2016. Main inclusion criteria were age ≥18 years, diagnosis of type 2 diabetes, and treated with insulin for at least 1 year prior to IDeg initiation. HbA1c, insulin dose, body weight, and body mass index were recorded before and 90 and 180 days post-switch.ResultsOf 211 eligible patients, 57% were male, mean age ± SD 62.2 ± 12.1 years, and diabetes duration >10 years. Switching to IDeg decreased HbA1c from a mean 8.8 ± 1.5% (73.0 ± 16.4 mmol/mol) baseline by 0.58 ± 1.0% (6.3 ± 10.9 mmol/mol) (p < 0.001). Baseline HbA1c of >8.5% (69.0 mmol/mol) and daily insulin dose of ≥50 U were associated with a greater reduction in HbA1c [1.0 ± 1.1% (10.9 ± 12.0 mmol/mol) and 1.2 ± 1.1% (13.1 ± 12.0 mmol/mol), respectively] compared with the total population. At 180 days post-switch, the mean daily basal insulin dose increased by 2 U compared with pre-switch. There was no significant change in body weight post-switch.ConclusionsIn a real-world setting, switching from another insulin to IDeg significantly improved glycemic control in patients with type 2 diabetes, without significant weight gain and with only a modest increase in insulin dose after IDeg initiation.FundingNovo Nordisk.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0297-9) contains supplementary material, which is available to authorized users.

Comparison of Efficacy and Safety of Glargine and Detemir Insulin in the Management of Inpatient Hyperglycemia and Diabetes

Glargine and detemir insulin are the two most commonly prescribed basal insulin analogues for the ambulatory and inpatient management of diabetes. The efficacy and safety of basal insulin analogues in the hospital setting has not been established. This observational study compared differences in glycemic control and outcomes in non-intensive care unit patients with blood glucose (BG) >140 mg/dL who were treated with glargine or detemir, between January 1, 2012, and September 30, 2015, in two academic centers. Among 6,245 medical and surgical patients with hyperglycemia, 5,749 received one or more doses of glargine, and 496 patients received detemir during the hospital stay. There were no differences in the mean daily BG (glargine, 182 ± 46 mg/dL vs. detemir, 180 ± 44 mg/dL; P = .70). There were no differences in mortality, hospital complications, or re-admissions between groups (all, P>.05). After adjusting for potential confounders, there was no statistically significant difference in hypoglycemia rates between treatment groups. Patients treated with detemir required higher total daily basal insulin doses (0.27 ± 0.16 units/kg/day vs. 0.22 ± 0.15 units/kg/day; P<.001). Glargine-treated patients had statistically longer length of stay; however, this difference may not be clinically relevant (6.8 ± 7.4 days vs. 6.0 ± 6.3 days; P<.001). Our study indicates that treatment with glargine and detemir results in similar inpatient glycemic control in general medicine and surgery patients. Detemir treatment was associated with higher daily basal insulin dose and number of injections. A prospective randomized study is needed to confirm these findings. BG = blood glucose BMI = body mass index CI = confidence interval eGFR = estimated glomerular filtration rate HbA1c = glycated hemoglobin ICD-9 = International Classification of Diseases, ninth revision ICU = intensive care unit IQR = interquartile range LOS = length-of-stay OR = odd ratio.