Glargine Research Articles

Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in Japanese individuals with type 2 diabetes: A subgroup analysis of the ONWARDS 1, 2 and 4 trials.

To explore the efficacy and safety of once-weekly insulin icodec (icodec) in Japanese adults (≥20 years old) with type 2 diabetes from the global ONWARDS 1, 2 and 4 trials. Insulin-naive (ONWARDS 1) and insulin-experienced (ONWARDS 2 and 4) individuals were randomized to icodec or a once-daily insulin comparator: insulin glargine U100 [ONWARDS 1 (basal insulin only) and 4 (basal-bolus regimen)] or insulin degludec [ONWARDS 2 (basal insulin only)]. The primary outcome was change in glycated haemoglobin from baseline to end of treatment (EOT) (ONWARDS 1: Week 52; ONWARDS 2 and 4: Week 26). Here, we present the Japanese subgroup results. Similar reductions in glycated haemoglobin from baseline to EOT were observed in each trial for icodec and comparators. The proportion of time in range (blood glucose 3.9-10.0 mmol/L) at EOT was also comparable across treatment groups (time in range: 58%-68%), as was time spent with blood glucose below 3.0 mmol/L (<1.0%). Combined clinically significant (blood glucose <3.0 mmol/L) or severe (requiring external assistance for recovery) hypoglycaemia rates were low, with no severe events (ONWARDS 1 and 2) or a single severe event (ONWARDS 4; icodec group) reported. These results generally aligned with findings from the respective global populations. No new safety issues were identified. Icodec improved glycaemic control to a similar degree as once-daily basal insulin comparators while maintaining low levels of clinically significant or severe hypoglycaemia. The findings support icodec use in Japanese individuals with different levels of type 2 diabetes progression.

Quality of Life in Japanese People with Type 2 Diabetes Switching from Multiple Daily Insulin Injections to Once-Daily iGlarLixi: SIMPLIFY Japan.

Previous studies have shown that iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, provides effective glycemic control in people with type 2 diabetes (T2D). The SIMPLIFY Japan study assessed the impact of switching from multiple daily insulin injections (MDI) to once-daily iGlarLixi on health-related quality of life (HRQOL) and glycemic parameters in Japanese people with moderately controlled T2D. This 24-week, prospective, observational cohort study enrolled Japanese adults with T2D who switched from MDI therapy to iGlarLixi. Data were collected at baseline, 12, and 24weeks; changes in Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire score, glycated hemoglobin (HbA1c), body weight and self-reported treatment adherence were evaluated; the primary endpoint was change in DTR-QOL at 24weeks. Sixty-six participants were enrolled and 61 were included in the full analysis set. Significant improvements were observed in total DTR-QOL score from baseline to week 24 (mean change + 10.8 points; P < 0.001), with higher scores observed in individual domains related to social/daily activities, treatment satisfaction, and reductions in treatment-related anxiety (P < 0.05). A small HbA1c increase was noted at week 24 (P < 0.001), while this did not appear to adversely affect HRQOL or treatment satisfaction. A significant reduction in body weight was observed at week 12 (mean change - 0.7kg; P = 0.046). Self-reported treatment adherence increased from baseline to week 24, with the proportion of participants who never missed an insulin injection increasing from 55.7 to 77.6%. At week 24, the incidence of hypoglycemia and gastrointestinal adverse events was 18.2 and 27.3%, respectively. Switching from MDI to iGlarLixi therapy in Japanese people with T2D was associated with enhanced HRQOL (despite slight elevation in HbA1c) and improved treatment adherence, with a favorable safety profile. These findings support the beneficial role of iGlarLixi in the management of T2D in real-world Japanese clinical practice. Japan Registry of Clinical Trials (jRCT1041210151).

A post-hoc pooled analysis to evaluate efficacy and safety of insulin glargine 300 U/mL in insulin-naïve people with type 2 diabetes with/without prior use of glucagon-like peptide-1 receptor agonist therapy

AimsTo evaluate treatment advancement with insulin glargine 300 U/mL (Gla-300), with or without prior glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D). MethodsEfficacy and safety outcomes of insulin-naïve patients intensifying with Gla-300, with/without prior GLP-1 RA therapy, were evaluated in three analyses (N = 3562): a pooled analysis of seven interventional studies, a subanalysis comparing participants who stopped GLP-1 RA therapy and initiated Gla-300 with those who received add-on Gla-300, and an expanded analysis including two observational studies. ResultsGlycaemic outcomes, including HbA1c improvement and fasting plasma glucose, were similar between groups with/without prior GLP-1 RA use. HbA1c least squares mean change from baseline was − 1.7 % and − 1.6 % with and without prior GLP-1 RA, respectively. Glycaemic outcomes were similar between participants who stopped GLP-1 RA therapy when initiating Gla-300 and those who received add-on Gla-300, although more participants receiving add-on Gla-300 achieved HbA1c targets. The expanded analysis yielded similar results. Incidence of hypoglycaemia was low with no clinically relevant weight changes in all analyses. ConclusionsTreatment advancement with Gla-300 in patients with T2D, with/without prior GLP-1 RA therapy, improved glycaemic outcomes with no relevant impact on weight, while maintaining a low hypoglycaemia risk.

Comparison of Effectiveness of Insulin Glargine in Combination with Oral Hypoglycemic Agents Versus Continued Premixed Insulin in Indian Type II Diabetes Patients: Randomized Controlled Trial

Comparison of Effectiveness of Insulin Glargine in Combination with Oral Hypoglycemic Agents Versus Continued Premixed Insulin in Indian Type II Diabetes Patients: Randomized Controlled Trial

Real-Life Effectiveness of iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) in People with Type 2 Diabetes (T2D) According to Baseline HbA1c and BMI.

This study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice. We pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m2 and 510 (36%) a BMI < 30 kg/m2; in the HbA1c set, 615 (44%) people had an HbA1c >9%, 491 (35%) between 8 and 9%, and 298 (21%) < 8%. After initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c > 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups. Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.

Time-in-range derived from self-measured blood glucose in people with type 2 diabetes advancing to iGlarLixi: A participant-level pooled analysis of three phase 3 LixiLan randomized controlled trials.

To evaluate the efficacy of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D) using derived time-in-range (dTIR). Participant-level data from LixiLan-L, LixiLan-O and LixiLan-G were pooled and dTIR (70-180 mg/dL), derived time-above-range (> 180 mg/dL) and derived time-below-range (dTBR; < 70 mg/dL) were calculated from participant seven-point self-monitored blood glucose profiles. This pooled analysis included data from 2420 participants receiving iGlarLixi (n = 1093), iGlar (n = 836), Lixi (n = 234) or a glucagon-like peptide-1 receptor agonist (GLP-1 RA) (n = 257). Numerically greater improvements in least square (LS) means dTIR were seen from baseline to end of treatment (EOT) with iGlarLixi (25.7%) versus iGlar (15.8%), Lixi (11.7%) or GLP-1 RA (16.2%). At EOT, the mean (standard deviation) dTBR was 0.71% ± 3.4%, 0.61% ± 3.2%, 0.08% ± 1.0% and 0.0% ± 0.0% for iGlarLixi, iGlar, Lixi and GLP-1 RA, respectively. In a subgroup analysis, participants aged younger than 65 years (n = 1690) and 65 years or older (n = 713) showed numerically greater improvements in LS means dTIR from baseline to EOT with iGlarLixi versus iGlar, Lixi or GLP-1 RA. iGlarLixi achieved improvements in dTIR, with low dTBR values, providing further evidence to inform clinical outcomes with the use of iGlarLixi.

Abstract P121: Weight Loss is not a Major Mediator of GLP1-Receptor Agonists’ Risk Reduction in Heart Failure with Preserved Ejection Fraction

The cardioprotective effects of GLP1-Receptor Agonists (GLP1-RA) and SGLT2 Inhibitors (SGLT2i) are incompletely understood. We compared these two drug classes and their effect on HFpEF hospitalizations and examined the hypothesis that weight loss is a significant mediator of these agents’ HFpEF protection. Methods: Using the VA Informatics and Computing Infrastructure, we generated a national cohort of veterans with type 2 diabetes on metformin who initiated SGLT2i, GLP1-RA or Insulin Glargine for the first time from 1/1/18 to 12/31/21. The index date was the date of first outpatient prescription fill. We defined 6-month weight change as change from baseline weight (closest outpatient value prior to index date within 1 year) to 6 months (all averaged outpatient weights from index date to 6 months). Those with prior prescriptions for the study drugs from 1/1/08 and missing baseline or 6-month weights were excluded. HFpEF hospitalizations were defined by a previously-validated natural language processing algorithm using inpatient HF diagnostic codes and cardiac imaging dated closest to and within 180 days of the new code with ejection fraction ≥50%. Follow up was through 3/31/23. We performed mediation analyses to separate the direct effects (independent of 6-month weight change) and indirect effects (mediated through 6-month weight change) of the drug classes on time to HFpEF hospitalizations, adjusted for demographics, comorbidities, baseline labs and other medications, and diabetes severity. Results: Overall, 161,405 veterans initiated one of the study drugs and 105,439 had weight data. After excluding 760 veterans with HFpEF hospitalizations in the first 6 months, 104,679 were included in the analysis. Baseline demographics included mean age 64±11 years, 94% male and 75% white. Baseline BMI was 33±6 kg/m 2 . There were 1494 HFpEF hospitalizations/ 256,101 years of follow-up. Figure 1 shows weight over time by study drug class. Table 1 shows mediation analyses results. Conclusion: GLP1-RA lowered the risk of HFpEF hospitalizations versus the active comparator insulin glargine. This cardioprotection was not mediated by weight loss. GLP1-RA and SGLT2i show equivalent risk reduction. These agents' direct cardiac and vascular effects deserve further exploration.

Use of Degludec in Youth With Type 1 Diabetes and Recurrent Diabetic Ketoacidosis

This article describes a pediatric diabetes center quality improvement initiative to switch youth with type 1 diabetes and diabetic ketoacidosis (DKA) from insulin glargine to longer-duration insulin degludec to determine whether this change would reduce DKA recurrence. Overall the change in DKA recurrence with degludec was not statistically significant. However, subgroup analysis showed that race/ethnicity and insurance status were significantly associated with change in DKA rates. The association of degludec and decreased rates of repeat DKA in Hispanics and privately insured individuals require further exploration.

Considerations for practical use of tree-based scan statistics for signal detection using electronic healthcare data: a case study with insulin glargine

ABSTRACT Background Hypothesis-free signal detection (HFSD) methods such as tree-based scan statistics (TBSS) applied to longitudinal electronic healthcare data (EHD) are increasingly used in safety monitoring. However, challenges may arise in interpreting HFSD results alongside results from disproportionality analysis of spontaneous reporting. Research design and methods Using the anti-diabetes drug insulin glargine (Lantus®) we apply two different tree-based scan designs using TreeScan™ software on retrospective EHD and compare the results to one another as well as to results from a disproportionality analysis using SRD. Results The self-controlled tree temporal scan method produced the larger number of alerts relative to propensity-score matched approach; however, far fewer alerts were observed when analyses were limited to EHD in inpatient/emergency room settings only. Very few reference adverse events were observed using TBSS methods on EHD relative to disproportionality methods in SRD. Conclusion Differences in detected alerts between TBSS methods and between TBSS and disproportionality analysis of SRD are likely attributable to differences in data, comparator, and study design. Our results suggest that HFDS methods like TBSS applied to EHD may complement more traditional approaches such as disproportionality analysis of SRD to provide a more complete picture of product safety in the post-approval setting.

Comparison of Thrice-daily Novomix Insulin Versus Insulin Glargine Once-Daily Combined with Thrice-Daily Insulin Aspart on Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Cross-Sectional Study

Comparison of Thrice-daily Novomix Insulin Versus Insulin Glargine Once-Daily Combined with Thrice-Daily Insulin Aspart on Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Cross-Sectional Study

Management of diabetic ketoacidosis in children: Does early insulin glargine help improve outcomes?

Rebound hyperglycemia following the resolution of diabetic ketoacidosis (DKA) is common in pediatric patients with type 1 diabetes, increasing the risk of recurrent DKA and complicating the transition to subcutaneous insulin. Multiple studies suggest that early administration of long-acting insulin analogs during DKA management safely improves this transition. This study aimed to determine whether early insulin glargine administration in children with DKA prevents rebound hyperglycemia and recurrent ketosis without increasing the rate of hypoglycemia or hypokalemia. Patients aged <21 years presenting with DKA to Children's Mercy Kansas City between October 2012 and October 2016 were reviewed. They were categorized as Early (>4 h of overlap with intravenous [IV] insulin) and Late (<2 h of overlap) cohorts. We reviewed 546 DKA admissions (365 Early and 181 Late). Rebound hyperglycemia (>180 mg/dL) was lower in the Early group (66% vs. 85%, p ≤ 0.0001). Hypoglycemia (<70 mg/dL) during IV insulin administration was higher in the Early group than in the Late group (27% vs. 19%, p = 0.042). Hypoglycemia within 12 h of IV insulin discontinuation was lower in the Early group (16% vs. 26%, p = 0.012). Recurrent ketosis, hypokalemia, and cerebral edema were not different between the groups. Early glargine administration in pediatric DKA management is safe, decreases the rate of rebound hyperglycemia, and improves the transition to subcutaneous insulin. Hypoglycemia is less frequent following IV insulin discontinuation with early glargine, but the IV insulin rate may need to be reduced to minimize hypoglycemia during IV insulin infusion.

Optimization of a mass spectrometric analytical method for the quality assessment of insulin and its analogs.

The principal aim of this study was to optimize analytical methodology based on mass spectrometry for the evaluation of the quality of recombinant human insulin and its analogs. In this study ESI-MS was used to assess the quality of human insulin, short acting insulin analogs, insulin lispro, insulin aspart and insulin glulisine and long acting analogs including insulin glargine, insulin degludec, and insulin detemir, in respective pharmaceutical formulations. In this study, with the aimed to optimize analytical conditions, different factors influencing the analytical performance such as pH, ionic strength, sample dilution, organic solvent addition were addressed. The study results demonstrated that MS is a suitable technique for the analysis of biotechnological compounds like insulin and its analogs. Although the obtained results provide an important information regarding this methodology, further studies are needed to validate this analytical approach and check for its suitability to be used in the regulatory environment.

Efficacy and safety of insulin glargine 300 U/mL in people with type 2 diabetes in China: The INITIATION study.

To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with suboptimally controlled type 2 diabetes (T2D) in China. INITIATION (NCT05002933) was a prospective, interventional, multicentre, single-arm, phase IV study conducted in China. Individuals with suboptimally controlled T2D who were insulin naïve or switching from another basal insulin (insulin experienced) were included. The primary endpoint was the change in HbA1c from baseline to week 24. Safety assessments included hypoglycaemia and adverse events (AEs). In total, 568 participants were enrolled and 562 initiated Gla-300 treatment (189 in the insulin-naïve subgroup; 373 in the insulin-experienced subgroup). At week 24, the mean ± standard error (SE) change in HbA1c from baseline was -0.91% ± 0.05% (-9.9 ± 0.5 mmol/mol; P < .0001). Significant HbA1c reductions were also observed in the insulin-naïve (mean ± SE change: -1.38% ± 0.09% [-15.1 ± 1.0 mmol/mol]) and insulin-experienced (-0.68% ± 0.05% [-7.4 ± 0.5 mmol/mol]) subgroups (both P < .0001). During the 24-week treatment period, the incidence of confirmed hypoglycaemia (plasma glucose ≤ 3.9 mmol/L) was 39.7% for all hypoglycaemia and 13.3% for nocturnal hypoglycaemia; the incidence of severe hypoglycaemia was low (0.5%). Overall, treatment-emergent AEs (TEAEs) were reported in 126 participants (22.4%), with no serious treatment-related TEAEs. Gla-300 was effective in improving glycaemic control and had a relatively low risk of hypoglycaemia in people with suboptimally controlled T2D who were insulin naïve or switching from another basal insulin in China.

Insulin icodec: A novel once-weekly treatment for diabetes.

To summarize the results of clinical studies of insulin icodec, an investigational insulin analog designed for once-weekly administration, in adults with type 1 and type 2 diabetes. Thirteen published articles describing clinical studies of insulin icodec were identified in PubMed, and data pertinent to key study outcomes were selected for inclusion in this review. In insulin-naïve and insulin-treated individuals, icodec demonstrated efficacy in glycaemic control superior or noninferior to that of insulins glargine U100, glargine U300 and degludec. Icodec exhibited a safety profile comparable to marketed insulins, with the exception of hypoglycaemic event rates. As a once-weekly alternative to daily basal insulin, icodec is expected to improve patient adherence and satisfaction, reducing the required number of injections per year from 365 to 52 and providing a dosing option potentially attractive to a wide range of insulin users. However, clinical data suggest a notable risk of hypoglycaemia with weekly icodec administration, especially in individuals with type 1 diabetes.

Research Progress on the Efficacy and Safety of Different Basal Insulins in the Treatment of Type 2 Diabetes Mellitus

Objective: To evaluate the efficacy and safety of different basal insulins in the treatment of type 2 diabetes mellitus (T2DM). Methods: The current research progress on different basal insulins was evaluated, with efficacy indicators including fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c), and safety indicators focusing mainly on weight change and the incidence of hypoglycemia. Results: Several different basal insulins showed similar metabolic control effects in terms of fasting plasma glucose and glycated hemoglobin. However, the risk of hypoglycemia was lower with insulin glargine 300 (Glar-300), insulin degludec 100 (Deg-100), and insulin degludec 200 (Deg-200) compared to insulin glargine 100 (Glar-100). Additionally, Glar-300 had the least impact on weight. Conclusion: For the treatment of T2DM, different basal insulins have similar therapeutic effects, but there are differences in the incidence of hypoglycemic events and their impact on weight. Rational insulin selection and dosage adjustments should be made based on the different patient groups.

Association between glucose-lowering drugs and circulating insulin antibodies induced by insulin therapy in patients with type 2 diabetes.

Insulin antibodies (IAs) affect blood glucose control in patients receiving insulin therapy. To investigate the relationship between different hypoglycemic treatments and IAs in patients with type 2 diabetes mellitus (T2DM). This cross-sectional, retrospective study included 1863 patients with T2DM who were receiving exogenous insulin therapy. All patients received stable antidiabetic therapy in the last 3 months and IA levels were measured using an iodine-125 array. A total of 1863 patients were enrolled. There were 902 (48.4%) patients who had positive IAs (IA level > 5%), with a mean IA level of 11.06% (10.39%-11.72%). IA levels were positively correlated with high fasting blood glucose (odds ratio = 1.069, P < 0.001). The proportion of positive IAs was lowest in patients using glargine only (31.9%) and highest in patients using human insulin only (70.3%), P < 0.001. The IA levels in patients using sulfonylureas/glinides (8.3%), metformin (9.6%), and dipeptidyl peptidase-4 inhibitors (8.2%) were all lower than in patients without these drugs (all P < 0.05). Nearly half of patients on insulin therapy have positive IA antibodies, and IA antibody levels are associated with blood glucose control. Insulin glargine and a combination of oral glucose-lowering drugs were correlated with lower IA levels.

Availability and pricing of insulin and related diagnostics in South Africa.

In South Africa (SA), most patients rely on the government for free healthcare. Some choose to subscribe to a medical insurance scheme. If insulin is unavailable in government or otherwise unaffordable, non-adherence may occur, which can increase complications of the disease. Data on availability and pricing of insulin and related diagnostics was collected from SA pharmacies via an online survey. Co-payments levied on insulin by the biggest medical aids were extracted from formularies. Affordability of these items was then assessed. An adapted methodology from the World Health Organization/Health Action International tool was used. There was fairly high availability of insulin in the public sector, with the exception of long-acting insulin which respondents claimed was difficult to find; however, long-acting insulin glargine was available in most private sector pharmacies. Point-of-care (POC) blood glucose testing was free in the public sector but offered in only 31.25% of pharmacies. Patients pay a minimum of USD 40.4 (over 3 days' wages for the lowest paid government worker (LPGW)) for a months' supply of the cheapest insulin, needles and test strips. Insulin in SA was cheaper than 5 other countries, except Australia. Overall, there is a good availability of insulin and related diagnostics in SA. Even though insulin is cheaper than other countries, it is unaffordable to the LPGW. This highlights the importance of ensuring a constant availability of insulin in the free public sector. Whilst human insulins are cheaper than newer analogue insulins and SA faces cost constraints, important variables in favour of newer insulins, such as ease-of-use, long term outcomes and value should be considered when treatment guidelines are updated. Annual POC testing should be available and offered free to all patients to detect diabetes early.

Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes

BackgroundLow adherence to the number of insulin injections and glycemic variability are among the challenges of insulin therapy in type 1 diabetes (T1D). The TOP1 study investigated the effect of switching from twice-daily (BID) basal insulin to once daily (OD) insulin glargine 300 U/mL (Gla-300) on glycemic control and quality of life.MethodsIn this 28-week, phase 4 trial, people with T1D aged ≥ 18 years, who were treated with BID basal insulin in combination with prandial rapid-acting insulin for at least 1 year, and had HbA1c between 7.5% and 10.0%, were switched to Gla-300 OD as basal insulin. The present study aimed to evaluate the impact of this change on HbA1c, glycemic profile, treatment satisfaction and safety. The change in HbA1c from baseline to Week 24 was the primary endpoint.ResultsOne hundred and twenty-three people with T1D (mean age 37 ± 11 years; 54.5% female) were studied. The disease duration was 20.0 ± 9.8 years, baseline HbA1c and fasting plasma glucose (FPG) were 8.6 ± 0.7% and 201 ± 80.3 mg/dL, respectively. After switching from BID to OD insulin regimen, no significant change in HbA1c was observed from baseline to Week 24 (p = 0.873). There were significant reductions in fasting self-monitoring blood glucose (SMBG) from baseline to Week 24 (175 ± 42 vs. 156 ± 38 mg/dL; p < 0.0001), and in glycemic profile (8-point SMBG) at several time points. There was a significant decrease in the proportion of patients with at least one hypoglycemic event (p = 0.025), in numbers of hypoglycemic events per patient-years of any type (p = 0.036), symptomatic (p = 0.007), and confirmed ≤ 70 mg/dL events (p = 0.049) from run-in to the last 4 weeks on treatment. There were significant improvements in treatment satisfaction (p < 0.0001), perceived hyperglycemia (p < 0.0001) scores and satisfaction with the number of injections between post-run-in and Week 24, and a significant decrease in fear of hypoglycemia.ConclusionsSwitch from BID basal insulin to OD Gla-300 as part of basal bolus therapy in T1D resulted in similar glycemic control as measured by HbA1c, but provided significant improvements in SMBG, daily glucose profile, a lower incidence of hypoglycemia and increased patient satisfaction.Trial registrationNCT03406000.

Study of the Relationship between Diabetic Retinopathy, Basal Insulin Therapy (Glargine or NPH) and Insulin-Like Growth Factor 1 Serum Level

Abstract Background Diabetic retinopathy (DR) is the major cause of preventable blindness worldwide. DR is a microvascular complication of diabetes mellitus that is more prevalent in patients with type 1 diabetes. Type 1 diabetes mellitus is an autoimmune disease that leads to insulin deficiency so patients require long term therapy with basal insulin for optimum glycemic control. Insulin- like growth factor 1 (IGF-1) is an important growth factor that is involved in cell proliferation and angiogenesis. There is a lot of evidence that IGF-1 is tightly related to DR development. Insulin Glargine is a long-acting insulin analogue which is peak-free and less hypoglycemic as compared to the intermediate-acting NPH insulin. Glargine has an increased affinity to IGF-1 receptor and this raised concern about its role in development of DR. The relationship between diabetic retinopathy, basal insulin therapy and IGF-1 serum level is still in debate. Aim we aimed to compare the incidence and severity of diabetic retinopathy in type 1 diabetic patients on basal insulin therapy (Glargine or NPH) and its relation to serum IGF-1 level. Methods The current study included 88 subjects with type 1 diabetes divided into 44 on basal insulin therapy with Glargine and actrapid ( Group A) and 44 on NPH and actrapid ( Group B). Hemoglobin A1c, Total cholesterol, Triglycerides, High density lipoproteins, Low density lipoproteins and serum IGF-1 levels were assessed. Full clinical examination including (weight, height, BMI), vital signs (pulse, blood pressure) was done and Fundus examination by Optomed Aurora® IQ handheld fundus camera. Results On comparing the 2 studied groups, There was no statistical significant difference as regarding fundus examination findings between studied groups (P value = 0.429). There was no statistically significant relation between diabetic retinopathy and serum IGF-1 (P value = .080 with Mean ± SD of serum IGF-1 level in patients with Normal fundus 14.8 ± 11 vs. Patients with Diabetic retinopathy 21.3 ± 16.9). There was statistically significant association between diabetic retinopathy and duration of diabetes (P value&amp;lt; 0.05 with Mean ± SD of diabetes duration in patients with Diabetic retinopathy 17.7 ± 6.9 vs. Patients with Normal fundus 14.6 ± 5.6). There was a statistical significant difference as regarding age (P value&amp;lt; 0.05 with Mean ± SD of age in Group B regimen 28.4 ± 6.7 vs. Group A 25.5 ± 4.9). Conclusion Serum IGF-1 levels showed no statistically significant difference in patients either on Glargine or NPH and also in patients either with normal fundus or with diabetic retinopathy. The incidence and severity of diabetic retinopathy in patients with type 1 diabetes mellitus is directly proportionate to duration of disease. No noted difference concerning diabetic retinopathy changes between patients on basal insulin therapy either Glargine or NPH.

Comparison of Two Financial Incentives to Encourage the Use of Adalimumab Biosimilars: Results of a French Experiment Close to Clinicians.

In 2018, the French government introduced two mutually exclusive financial incentives to increase etanercept and insulin glargine biosimilar use. The general case redirects 20% of the price difference between the reference product and its biosimilars to hospitals for every biosimilar dispensed in community pharmacies from hospital prescriptions. The experimental case redirects 30% to prescribing clinical units after hospital selection. Adalimumab was added to these incentives in 2019, after its first biosimilar was launched. This retrospective observational study aimed to compare both general and experimental incentives after 19 months to assess the impact of directly incentivizing clinical units for adalimumab biosimilars. The monthly number of adalimumab boxes dispensed in community pharmacies was linked to the corresponding hospital's prescription using IQVIA Xponent data from November 2017 to October 2020. The monthly mean rate of adalimumab biosimilars was compared between incentive groups and subgroups depending on hospitals' prior experience with the etanercept experimental case. General case hospitals had a significantly lower mean biosimilar uptake (16.7% vs 23.2%, p = 0.029) than those included in the experimental case. Twenty-three of the 40 hospitals in the experimental case and ten out of the 91 hospitals studied in the general case had already taken part in the etanercept experiment. Biosimilar uptake was higher, but not statistically significant, for hospitals with prior experience in the adalimumab general case group (p = 0.086). This study confirmed that incentivizing close to physicians was more effective in increasing the biosimilar rate. It also suggested that previous incentive experience positively influenced biosimilar penetration.