insulin-glargine and Drug-Hypersensitivity

Insulin allergy is a rare yet severe side effect of exogenous insulin use. Management typically involves use of alternative antihyperglycaemic agents, symptom control with antihistamines, use of different insulin formulations, and induction of tolerance with incremental doses of insulin. This treatment regimen is not always successful, and the use of omalizumab, an anti-IgE monoclonal antibody, has been used to induce tolerance to insulin.. G.M. is a 62-year-old man with Type 2 diabetes mellitus. His condition was not optimized on oral agents, and insulin therapy was required. G.M. had anaphylaxis to insulin NPH, and subsequent skin-prick testing was positive to insulin aspart, insulin NPH, insulin glulisine, insulin detemir, regular insulin, insulin glargine 100 units/ml and insulin glargine 300 units/ml. He received incremental doses of several insulin formulations; however, he experienced diffuse urticaria preventing optimal glycaemic control. Three successful cases have been described in the literature of omalizumab inducing tolerance to exogenous insulin; therefore, G.M. was started on omalizumab. He subsequently tolerated treatment doses of insulin glulisine and insulin detemir with no allergic reactions and with improvement in glycaemic control.. To our knowledge, this is the first described case of allergy to insulin glargine 300 units/ml and reiterates the potential use of omalizumab in insulin allergy. Further research is warranted to determine if omalizumab should be considered standard of care in difficult-to-treat insulin hypersensitivity.

Topics: Anaphylaxis; Anti-Allergic Agents; Diabetes Mellitus, Type 2; Drug Hypersensitivity; Humans; Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin, Isophane; Male; Middle Aged; Omalizumab

Insulin has an important role in the treatment of diabetic patients. Further, it can result in undesirable side effects. One of the problems that are associated with insulin therapy is allergic reactions. Although insulin allergy is uncommon, especially in patients with type-2 diabetes, but when it occurs, its management can be difficult. We report a 55-year-old woman with poorly controlled type-2 diabetes and insulin allergy. She revealed hypersensitivity reactions including urticaria and respiratory symptoms, immediately after injection. So, specific immunotherapy with other insulin preparations was done. Finally, after specific immunotherapy, we were able to treat the patient with short- and long-acting analogs successfully.

Topics: Diabetes Mellitus, Type 2; Drug Hypersensitivity; Female; Humans; Immunotherapy; Insulin; Insulin Glargine; Insulin, Long-Acting; Middle Aged; Substrate Specificity

SAR342434 is a biosimilar follow-on of insulin lispro-Humalog. SORELLA-1 was a randomized, open-label phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension. Assessments included change in HbA. Five hundred seven patients were randomized (SAR-Lis n = 253; Ly-Lis n = 254). Least square (LS) mean (SEM) change in glycosylated hemoglobin (HbA1c) (baseline to week 26; primary endpoint) was similar in both treatment groups (SAR-Lis: -0.42% [0.051]; Ly-Lis: -0.47% [0.050]). Noninferiority at prespecified 0.3% noninferiority margin and inverse noninferiority were demonstrated (LS mean difference of SAR-Lis vs. Ly-Lis: 0.06% [95% confidence interval: -0.084 to 0.197]). At week 52 (end of extension period) versus week 26, a small HbA1c increase was observed in both groups. FPG and seven-point SMPG profile changes, including postprandial glucose excursions, were similar between groups. At week 52, similar changes in mean daily mealtime and basal insulin doses were observed. Hypoglycemia, TEAEs, and AIAs (incidence, prevalence) did not differ between groups.. Results from this controlled study in patients with T1DM also using GLA-100 support similar efficacy and long-term safety (including immunogenicity) of SAR-Lis and Ly-Lis.

Topics: Adult; Autoantibodies; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 1; Drug Administration Schedule; Drug Hypersensitivity; Drug Therapy, Combination; Equivalence Trials as Topic; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Incidence; Injections, Subcutaneous; Insulin Glargine; Insulin Lispro; Intention to Treat Analysis; Patient Dropouts; Prevalence

To compare the immunogenicity profiles and the potential effects on clinical outcomes of LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), products with identical primary amino acid sequences, in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM).. To assess immunogenicity, anti-insulin glargine antibodies (measured as percent binding) were compared between treatments in 52-week (open-label) and 24-week (double-blind) randomized studies in total study populations of patients with T1DM (N = 535) and T2DM (N = 756), respectively, and two subgroups of patients with T2DM: insulin-naïve patients and those reporting prestudy IGlar treatment (prior IGlar). Relationships between insulin antibody levels and clinical outcomes were assessed using analysis of covariance and partial correlations. Insulin antibody levels were assessed using Wilcoxon rank sum. Treatment comparisons for treatment-emergent antibody response (TEAR) and incidence of detectable antibodies were analysed using Fisher's exact test.. No significant treatment differences were observed for insulin antibody levels, incidence of detectable anti-insulin glargine antibodies, or incidence of TEAR [overall and endpoint, by last-observation-carried-forward (LOCF)] in patients with T1DM or patients with T2DM, including the insulin-naïve subgroup. A statistically significant difference was noted in the overall incidence of detectable antibodies but not at endpoint (LOCF) nor in TEAR for the prior IGlar subgroup of patients with T2DM. Insulin antibody levels were low (<5%) in both treatment groups. Insulin antibody levels or developing TEAR was not associated with clinical outcomes.. LY IGlar and IGlar have similar immunogenicity profiles; anti-insulin glargine antibody levels were low for both treatments, with no observed effect on efficacy and safety outcomes.

Topics: Asymptomatic Diseases; Biosimilar Pharmaceuticals; Cross Reactions; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Hypersensitivity; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Immunogenetic Phenomena; Incidence; Insulin Antibodies; Insulin Glargine; Insulin, Regular, Human; Recombinant Proteins

The objective of this study was to compare the efficacy and safety of insulin glargine, a long-acting insulin analog, with NPH insulin in children and adolescents with type 1 diabetes mellitus (T1DM). In a multicenter, open-label, randomized, 6-month study, 349 patients with TIDM, aged 5-16 years, received insulin glargine once daily or NPH insulin either once or twice daily, based on their prior treatment regimen. Although there was no significant difference between the NPH insulin and insulin glargine treatment groups with respect to baseline to endpoint change in HbA1c levels, fasting blood glucose (FBG) levels decreased significantly more in the insulin glargine group (-1.29 mmol/l) than in the NPH insulin group (-0.68 mmol/L, p = 0.02). The percentage of symptomatic hypoglycemic events was similar between groups; however, fewer patients in the insulin glargine group reported severe hypoglycemia (23% vs 29%) and severe nocturnal hypoglycemia (13% vs 18%), although these differences were not statistically significant (p = 0.22 and p = 0.19, respectively). Fewer serious adverse events occurred in the insulin glargine group than in the NPH insulin group (p < 0.02). A once-daily subcutaneous dose of insulin glargine provides effective glycemic control and is well tolerated in children and adolescents with T1DM.

Topics: Adolescent; Age of Onset; Blood Glucose; Child; Child, Preschool; Diabetes Mellitus, Type 1; Double-Blind Method; Drug Hypersensitivity; Female; Glycated Hemoglobin; Humans; Hyperglycemia; Insulin; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Male; Multicenter Studies as Topic; Puberty

Topics: Desensitization, Immunologic; Diabetes Mellitus, Type 2; Drug Hypersensitivity; Humans; Insulin; Insulin Glargine; Insulin Infusion Systems; Insulin, Long-Acting; Male; Middle Aged; Treatment Outcome

Insulin allergy is a rare clinical situation. We report a 51-year-old patient with type 2 diabetes who required multiple daily insulin injections. The patient developed allergy to human regular insulin and insulin analogs (insulin aspart and insulin glargine), which was resolved by subcutaneous insulin desensitization.

Topics: Desensitization, Immunologic; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Hypersensitivity; Humans; Insulin; Insulin Aspart; Insulin Glargine; Insulin, Long-Acting; Male; Middle Aged

The patient was a 56-year-old man with type 2 diabetes and insulin allergy. He was administered glargine, which did not produce any allergic reactions, except for a small non-pruritic wheal. Thereafter, other insulin preparation could be administered. We consider this the first case of successful insulin desensitization by glargine administration.

Topics: Desensitization, Immunologic; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Hypersensitivity; Glycated Hemoglobin; Humans; Insulin; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Male; Middle Aged

Topics: Adult; Dermatitis, Atopic; Diabetes Complications; Diabetes Mellitus, Type 1; Drug Hypersensitivity; Female; Humans; Hypoglycemic Agents; Immunoglobulin G; Insulin; Insulin Antibodies; Insulin Glargine; Insulin, Long-Acting

Topics: Diabetes Mellitus, Type 1; Drug Hypersensitivity; Female; Humans; Hypoglycemic Agents; Infant; Infant, Newborn; Infant, Small for Gestational Age; Insulin; Insulin Glargine; Insulin Lispro; Insulin, Long-Acting

Topics: Aged; Aged, 80 and over; Drug Hypersensitivity; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Male; Skin Tests

Topics: Diabetes Mellitus, Type 1; Drug Hypersensitivity; Humans; Insulin; Insulin Glargine; Insulin, Long-Acting; Male; Middle Aged