Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study
Diabetes Technology& Therapeutics , Vol. 0, No. 0. (Source: Diabetes Technology and Therapeutics)
Source: Diabetes Technology and Therapeutics - December 12, 2017 Category: Endocrinology Authors: Karl-Michael Derwahl Timothy S. Bailey Karin Wernicke-Panten Lin Ping Suzanne Pierre Source Type: research

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study
Diabetes Technology& Therapeutics , Vol. 0, No. 0. (Source: Diabetes Technology)
Source: Diabetes Technology - December 12, 2017 Category: Endocrinology Authors: Karl-Michael Derwahl Timothy S. Bailey Karin Wernicke-Panten Lin Ping Suzanne Pierre Source Type: research

Understanding concentrated insulins: a systematic review of randomized controlled trials.
CONCLUSION: Concentrated-insulin products demonstrated efficacious and safe outcomes in appropriate patients. Clinical findings (HbA1c and hypoglycemia) and methodology (initiation and titration), patient factors (insulin experience and dosing requirements), and treatment characteristics (bioequivalence, potency, and device features) are important considerations. This overview of these and other factors provides essential information and guidance for using concentrated insulins in clinical practice. PMID: 29166786 [PubMed - as supplied by publisher] (Source: Current Medical Research and Opinion)
Source: Current Medical Research and Opinion - November 25, 2017 Category: Research Tags: Curr Med Res Opin Source Type: research

A standardized approach based on dietary and multiple daily insulin injections for the management of diabetes in infants
In this study, the infants were fed at 3- to 4-h intervals. All patients were started on insulin therapy with 0.6  U/kg/day divided equally into four doses. The morning, noon, and evening doses were given as premixed insulin (25% insulin lispro and 75% insulin lispro protamin sulphate), while the night insulin dose was given as premixed or neutral protamin Hagedorn (NPH) insulin according to the feeding freque ncy during the night. Nine-point capillary blood glucose profiles, HbA1c, and anthropometric measurements were evaluated. The study had 15 infants diagnosed with neonatal diabetes (ND) or type 1 diabetes mellitus (T...
Source: International Journal of Diabetes in Developing Countries - November 17, 2017 Category: Endocrinology Source Type: research

Baseline factors associated with better response to insulin lispro low mixture or insulin glargine: A post hoc analysis of the DURABLE study
Insulin therapy is required in patients with type 2 diabetes mellitus (T2D) when dietary restrictions and lifestyle modifications combined with oral hypoglycemic agents (OHAs) fail to provide acceptable metabolic control [1 –4]. However, insulin initiation is often delayed in patients who are not adequately controlled on OHAs, despite evidence that maintaining HbA1c levels (Source: Diabetes Research and Clinical Practice)
Source: Diabetes Research and Clinical Practice - November 15, 2017 Category: Endocrinology Authors: Nan Jia, Zbigniew Kindracki, Angel Rodriguez Source Type: research

Identifying Insulin Treatment Responders with a Composite Measure: Beyond Hba1c < 7% in Patients with Type 2 Diabetes.
CONCLUSION: Composite HbA1c measures identified more patients with clinically meaningful responses to therapy than the broadly accepted HbA1c <7% and may be useful in assessing clinical trials, clinical care, and quality measures. PMID: 29065720 [PubMed - as supplied by publisher] (Source: Current Medical Research and Opinion)
Source: Current Medical Research and Opinion - October 29, 2017 Category: Research Tags: Curr Med Res Opin Source Type: research

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine —SORELLA 1 Study
Diabetes Technology& Therapeutics , Vol. 0, No. 0. (Source: Diabetes Technology and Therapeutics)
Source: Diabetes Technology and Therapeutics - August 30, 2017 Category: Endocrinology Authors: Satish K. Garg Karin Wernicke-Panten Maria Rojeski Suzanne Pierre Yvonne Kirchhein Krystyna Jedynasty Source Type: research

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine —SORELLA 1 Study
Diabetes Technology& Therapeutics , Vol. 0, No. 0. (Source: Diabetes Technology)
Source: Diabetes Technology - August 30, 2017 Category: Endocrinology Authors: Satish K. Garg Karin Wernicke-Panten Maria Rojeski Suzanne Pierre Yvonne Kirchhein Krystyna Jedynasty Source Type: research

Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens
ConclusionsThe preliminary results showed that the subgroup of patients with race other than Caucasian and FBG<8.89  mmol/L may respond better to premixed intensification therapy. This result provides some preliminary information for further investigation in prospective studies.FundingEli Lilly and Company.Clinical Trial RegistrationClinicaltrials.gov ID number: NCT00110370. (Source: Diabetes Therapy)
Source: Diabetes Therapy - June 30, 2017 Category: Endocrinology Source Type: research

Internalization and localization of basal insulin peglispro in cells
Conclusions Our findings show that treatment of cells with BIL stimulates internalization and localization of IR to early endosomes. Both the insulin and PEG moieties of BIL undergo a dynamic cellular process of rapid internalization and transport to early endosomes followed by loss of cellular immunostaining in a manner similar to that of insulin lispro and human insulin. The rate of clearance for the insulin lispro portion of BIL was slower than the rate of clearance for human insulin. In contrast, the PEG moiety of BIL can recycle out of cells. (Source: Molecular and Cellular Endocrinology)
Source: Molecular and Cellular Endocrinology - May 31, 2017 Category: Endocrinology Source Type: research

Insulin lispro 25/75 and insulin lispro 50/50 as starter insulin in Japanese patients with type 2 diabetes: subanalysis of the CLASSIFY randomized trial.
Authors: Watada H, Imori M, Li P, Iwamoto N Abstract In Japan, premixed insulins are commonly used as starter insulin for type 2 diabetes. This subpopulation analysis assessed the efficacy and safety of twice-daily LM25 (25% insulin lispro/75% insulin lispro protamine) and LM50 (50% insulin lispro/50% insulin lispro protamine) as starter insulin in Japanese subjects, and compared these results with the whole-trial populations of East Asian subjects. In this subpopulation analysis of an open-label, phase 4, randomized trial (CLASSIFY), Japanese subjects received LM25 (n = 88) or LM50 (n = 84) twice-daily fo...
Source: Endocrine Journal - May 26, 2017 Category: Endocrinology Tags: Endocr J Source Type: research

Higher concentration insulins: an overview of clinical considerations.
Authors: Reid TS, Schafer F, Brusko C Abstract Three higher concentration insulin products (insulin lispro 200 units/mL, insulin degludec 200 units/mL, and insulin glargine 300 units/mL) received US Food and Drug Administration (FDA) approval in 2015. Although human regular insulin 500 units/mL (U-500) was approved in 1997, a pen and dedicated U-500 syringe became available in 2016. These products offer more treatment options for the increasing numbers of patients requiring insulin to achieve and maintain glycemic targets. Higher concentration insulins have some unique safety and efficacy considerations. I...
Source: Postgraduate Medicine - May 9, 2017 Category: Internal Medicine Tags: Postgrad Med Source Type: research

Modeling Pharmacokinetic Profiles of Insulin Regimens to Enhance Understanding of Subcutaneous Insulin Regimens.
Abstract Insulin pharmacokinetics following subcutaneous administration were modeled, simulated, and displayed through an interactive and user-friendly interface to illustrate the time course of administered insulins frequently prescribed, providing a simple tool for clinicians through a straightforward visualization of insulin regimens. Pharmacokinetic data of insulin formulations with different onset and duration of action from several clinical studies, including insulin glargine, regular insulin, neutral protamine Hagedorn (NPH), insulin lispro, and premixed preparations of NPH with regular insulin (Mix...
Source: The Journal of Clinical Pharmacology - April 10, 2017 Category: Drugs & Pharmacology Authors: Tham LS, Schneck K, Ertekin A, Reviriego J Tags: J Clin Pharmacol Source Type: research

Long-acting insulin allergy in a diabetic child.
Authors: Mastrorilli C, Rizzuti L, Cangelosi AM, Iovane B, Chiari G, Caffarelli C Abstract Insulin allergy has been uncommon since the introduction of human recombinant insulin preparations; the prevalence is 2.4%. Insulin injection could elicit immediate reactions, which are usually induced by an IgE-mediated mechanism, within the first hour after drug administration. In the present study, we describe the case of a child who experienced immediate urticaria after long-acting insulin injection. A 9-year-old girl affected by type I diabetes mellitus referred a history of three episodes of urticaria 30 min af...
Source: International Journal of Immunopathology and Pharmacology - April 5, 2017 Category: Allergy & Immunology Tags: Int J Immunopathol Pharmacol Source Type: research

Chronic Toxicology Studies of Basal Insulin Peglispro in Rats and Dogs: A Novel, PEGylated Insulin Lispro Analog with a Prolonged Duration of Action.
Abstract Basal insulin peglispro (BIL) consists of insulin lispro with a 20-kDa polyethylene glycol (PEG) moiety covalently attached to lysine B28. Because chronic parenteral administration of PEGylated proteins to animals has sometimes resulted in PEG vacuolation of tissue macrophages, renal tubular cells, and choroid plexus ependymal cells, we investigated whether chronic subcutaneous (sc) injection of BIL in rats (52 weeks) and dogs (39 weeks) was associated with systemic toxicities or other changes, including vacuolation of tissue macrophages, renal tubular cells, and ependymal cells. Rats and dogs rec...
Source: Toxicologic Pathology - April 1, 2017 Category: Pathology Authors: Byrd RA, Blackbourne JL, Knadler MP, Schultze AE, Vahle JL Tags: Toxicol Pathol Source Type: research