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David R Owens - One of the best experts on this subject based on the ideXlab platform.
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the potential for improved glycaemic control−−Review: Insulin Glulisine Published by:
2014Co-Authors: David R OwensAbstract:Tight glycaemic control is essential to reduce therisk of developing the micro- and macrovascularcomplications of diabetes. Plasma levels of glycosylated haemoglobin (HbA1C) are a marker for long-term glycaemia; controlling these levels within tight limits forms the cornerstone of long-term diabetes management. As a result of evidence from key clinical trials in type 1 and type 2 diabetes, HbA1C targets ranging from < 6.5 to < 7.5 % have been set by various authorities. To achieve these targets, Insulin regimens need to reflect normal physiological Insulin release. Several rapid- and long-acting Insulin analogues have been developed to mimic aspects of Insulin secretion. Insulin Glulisine is a genetically engineered Insulin which has a rapid onset and short lived action, allowing it to closely mimic prandial release of Insulin. In addition to the structural change in the Insulin molecule, the absence of excess zinc and the addition of polysorbate 20 as a surfactant facilitates its disassociation in the subcutaneous tissue and inhibits its aggregation when used in subcutaneous Insulin delivery systems due to improved physical stability. Br J Diabetes Vasc Dis 2007;7:60-66 Key words: Insulin Glulisine, pharmacokinetics, pharmacodynamics, type 1 diabetes, type 2 diabetes
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effects of initiation and titration of a single pre prandial dose of Insulin Glulisine while continuing titrated Insulin glargine in type 2 diabetes a 6 month proof of concept study
Diabetes Obesity and Metabolism, 2011Co-Authors: David R Owens, S D Luzio, C Sertlangeron, Matthew C RiddleAbstract:Aim: Stepwise intensification of Insulin treatment to match the progressive decline of endogenous Insulin secretion has been shown to be an effective management strategy in type 2 diabetes mellitus (T2DM). The efficacy of initiating and titrating a single bolus dose of Insulin Glulisine to baseline Insulin glargine plus oral hypoglycaemic agents (OHAs) was investigated. Methods: This was a 6-month, parallel-group, randomized, open-label, Phase IV study conducted in the US, UK and Russia. People with T2DM (HbA1c 7.5–9.5%) using any basal Insulin underwent a 3-month run-in period on Insulin glargine titrated to optimize fasting blood glucose (BG) control. Those with HbA1c >7.0% were randomized to either continue prior therapy (n = 57) or to add a single dose of Insulin Glulisine (n = 49) immediately prior to the main meal for a further 3 months. Two different titration algorithms were employed for the bolus dose, targeting 2-h postprandial BG ≤135 mg/dL (≤7.5 mmol/l; Russia and UK) or pre-meal/bedtime BG 100–120 mg/dl (5.5–6.7 mmol/l; US). Results: HbA1c and fasting plasma glucose levels decreased during the run-in period. In the 3 months after randomization, more participants in the basal-plus-bolus group reached HbA1c <7.0% than the basal-only control group (22.4 vs. 8.8%; p < 0.05), with significantly greater reduction of HbA1c (−0.37 vs. −0.11%; p = 0.0290). Rates of hypoglycaemia and mean weight change were comparable between the treatment groups. Conclusions: In people with T2DM inadequately controlled on basal Insulin plus OHAs, adding a single injection of Insulin Glulisine prior to the main meal significantly improves glucose control without undesired side effects.
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comparative pharmacodynamic and pharmacokinetic characteristics of subcutaneous Insulin Glulisine and Insulin aspart prior to a standard meal in obese subjects with type 2 diabetes
Diabetes Obesity and Metabolism, 2011Co-Authors: Geremia B Bolli, C Sertlangeron, Stephen D Luzio, Stefania Marzotti, Francesca Porcellati, B Charbonnel, Y Zair, David R OwensAbstract:Aims: A multinational, randomized, double-blind, two-way crossover trial to compare the pharmacokinetic and pharmacodynamic properties of bolus, subcutaneously administered Insulin Glulisine (Glulisine) and Insulin aspart (aspart) in Insulin-naIve, obese subjects with type 2 diabetes. Methods: Thirty subjects [9/21 females/males; mean ± SD age: 60.7 ± 7.7 years; body mass index (BMI): 33.5 ± 3.3 kg/m2; duration of diabetes: 6.8 ± 4.6 years; HbA1c: 7.1 ± 0.8%] were included in the analysis. They fasted overnight and then received a 0.2 U/kg subcutaneous dose of Glulisine or aspart 2 min before starting a standardized test meal, 7 days apart, according to a randomization schedule. Blood samples were taken every 15 min, starting 20 min before the meal and ending 6 h postprandially. Results: The area under the absolute glucose concentration–time curve between 0 and 1 h after Insulin injection and maximal glucose concentration was significantly lower with Glulisine than with aspart (p = 0.0455 and 0.0337, respectively). However, for the total study period, plasma glucose concentration was similar for Glulisine and aspart. Peak Insulin concentration was significantly higher for Glulisine than for Insulin aspart (p < 0.0001). Hypoglycaemic events (≤ 70 mg/dl with or without symptoms) occurred in 13 and 16 subjects treated with Glulisine and aspart, respectively, but there were no cases of severe hypoglycaemia requiring intervention. Conclusions: Glulisine was associated with lower glucose levels during the first hour after a standard meal; the remaining glucose profiles were otherwise equivalent, with higher Insulin levels observed throughout the study period.
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a comparison of preprandial Insulin Glulisine versus Insulin lispro in people with type 2 diabetes over a 12 h period
Diabetes Research and Clinical Practice, 2008Co-Authors: S D Luzio, Rajesh Peter, Gareth Dunseath, Laila Mustafa, David R OwensAbstract:A comparison of the plasma glucose and Insulin day profiles between two prandial rapid-acting Insulin analogues, Insulin Glulisine (Glulisine) and Insulin lispro (lispro), in 18 obese subjects with Type 2 diabetes. Subjects (body mass index: males, 36.7 [33.2-43.8] kg/m(2); females, 40.0 [35.7-46.5] kg/m(2)) received subcutaneous Glulisine or lispro (0.15 U/kg) at 4-h intervals immediately (within 2 min) before three standard test meals during each of two 12-h, randomised, open-label, crossover studies (7+/-2-day interval between each). Overall, preprandial-subtracted glucose concentrations (area under the curve) were similar on the Glulisine and lispro study days. However, the mean of the three maximal preprandial subtracted plasma glucose concentrations (DeltaGLU(max)) were lower with Glulisine versus lispro (12%; p<0.01). Mean concentrations of Insulin analogue were significantly higher post-meal with Glulisine (p<0.01 for all). Post hoc analysis showed a significantly faster absorption rate for Glulisine versus lispro in the first 30 min post-meal (estimated difference 0.48 microU/min; p<0.0001). Only two cases of hypoglycaemia were reported; both from one subject during the lispro day. When Glulisine is injected immediately before a meal in obese patients with Type 2 diabetes, Glulisine achieves significantly lower glucose excursions over lispro. Significantly faster absorption with higher and sustained post-meal levels of Insulin analogue was achieved at every meal with Glulisine versus lispro.
Thomas Danne - One of the best experts on this subject based on the ideXlab platform.
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continuous subcutaneous Insulin infusion in diabetes patient populations safety efficacy and pharmacoeconomics
Diabetes-metabolism Research and Reviews, 2016Co-Authors: Paolo Pozzilli, Tadej Battelino, Thomas Danne, Roman Hovorka, Przemyslawa Jaroszchobot, E RenardAbstract:Summary The level of glycaemic control necessary to achieve optimal short-term and long-term outcomes in subjects with type 1 diabetes mellitus (T1DM) typically requires intensified Insulin therapy using multiple daily injections or continuous subcutaneous Insulin infusion. For continuous subcutaneous Insulin infusion, the Insulins of choice are the rapid-acting Insulin analogues, Insulin aspart, Insulin lispro and Insulin Glulisine. The advantages of continuous subcutaneous Insulin infusion over multiple daily injections in adult and paediatric populations with T1DM include superior glycaemic control, lower Insulin requirements and better health-related quality of life/patient satisfaction. An association between continuous subcutaneous Insulin infusion and reduced hypoglycaemic risk is more consistent in children/adolescents than in adults. The use of continuous subcutaneous Insulin infusion is widely recommended in both adult and paediatric T1DM populations but is limited in pregnant patients and those with type 2 diabetes mellitus. All available rapid-acting Insulin analogues are approved for use in adult, paediatric and pregnant populations. However, minimum patient age varies (Insulin lispro: no minimum; Insulin aspart: ≥2 years; Insulin Glulisine: ≥6 years) and experience in pregnancy ranges from extensive (Insulin aspart, Insulin lispro) to limited (Insulin Glulisine). Although more expensive than multiple daily injections, continuous subcutaneous Insulin infusion is cost-effective in selected patient groups. This comprehensive review focuses on the European situation and summarises evidence for the efficacy and safety of continuous subcutaneous Insulin infusion, particularly when used with rapid-acting Insulin analogues, in adult, paediatric and pregnant populations. The review also discusses relevant European guidelines; reviews issues that surround use of this technology; summarises the effects of continuous subcutaneous Insulin infusion on patients' health-related quality of life; reviews relevant pharmacoeconomic data; and discusses recent advances in pump technology, including the development of closed-loop ‘artificial pancreas’ systems. © 2015 The Authors. Diabetes/Metabolism Research and Reviews Published by John Wiley & Sons Ltd.
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comparable efficacy and safety of Insulin Glulisine and Insulin lispro when given as part of a basal bolus Insulin regimen in a 26 week trial in pediatric patients with type 1 diabetes
Diabetes Technology & Therapeutics, 2011Co-Authors: Areti Philotheou, Silva Arslanian, Laszlo Blatniczky, Valentina Peterkova, Elisabeth Souhami, Thomas DanneAbstract:Abstract Background: We compared the efficacy and safety of Insulin Glulisine with Insulin lispro as part of a basal–bolus regimen in children and adolescents with type 1 diabetes. Methods: Overall...
Caroline Whatelysmith - One of the best experts on this subject based on the ideXlab platform.
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intensifying Insulin regimen after basal Insulin optimization in adults with type 2 diabetes a 24 week randomized open label trial comparing Insulin glargine plus Insulin Glulisine with biphasic Insulin aspart lanscape
Diabetes Obesity and Metabolism, 2015Co-Authors: Jiten Vora, Neale Cohen, Marc Evans, Andrew Hockey, Jane Speight, Caroline WhatelysmithAbstract:Aim To test the hypothesis that a ‘basal plus’ regimenadding once-daily main-meal fast-acting Insulin to basal Insulin once dailywould be non-inferior to biphasic Insulin twice daily as assessed by glycated haemoglobin (HbA1c) concentration (predefined as ≤0.4%), but would provide superior treatment satisfaction. Methods This open-label trial enrolled adults to an 8- or 12-week run-in period, during which oral therapies except metformin were stopped and Insulin glargine dose was titrated. Those with fasting glucose 7% (53 mmol/mol) were randomized to Insulin glargine/Glulisine once daily (n = 170) or Insulin aspart/aspart protamine 30/70 twice daily (n = 165) for 24 weeks, with dose titration to glucose targets using standardized algorithms. Results For HbA1c, the basal plus regimen was non-inferior to biphasic Insulin (least squares mean difference, 0.21%, upper 97.5% confidence limit 0.38%) meeting the predefined non-inferiority margin of 0.4%. Treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire change version and Insulin Treatment Satisfaction Questionnaire total scores) significantly favoured basal plus. No difference was observed between the basal plus and the biphasic Insulin groups in responders (HbA1c <7%, 20.6 vs 27.9%; p = 0.12), weight gain (2.06 vs 2.50 kg; p = 0.2), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life average weighted impact (AWI) score) and generic health status (five-dimension European Quality of Life questionnaire). Overall hypoglycaemia rates were similar between groups (15.3 vs 18.2 events/patient-year; p = 0.22); nocturnal hypoglycaemia was higher with the basal plus regimen (5.7 vs 3.6 events/patient-year; p = 0.02). Conclusion In long-standing type 2 diabetes with suboptimal glycaemia despite oral therapies and basal Insulin, the basal plus regimen was non-inferior to biphasic Insulin for biomedical outcomes, with a similar overall hypoglycaemia rate but more nocturnal events.
Ponnusamy Saravanan - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Rapid-Acting Insulin Analogs in Special Populations with Type 1 Diabetes or Gestational Diabetes: Systematic Review and Meta-Analysis
Diabetes Therapy, 2018Co-Authors: Kirsten Norgaard, Nithya Sukumar, Snorri B. Rafnsson, Ponnusamy SaravananAbstract:IntroductionTo assess the efficacy and safety of three available rapid-acting Insulin analogs (Insulins lispro, aspart and Glulisine, respectively) in pregnant women, children/adolescents and people using continuous subcutaneous Insulin infusion (CSII) with type 1 diabetes.MethodsPubMed, EMBASE and Cochrane Reviews were searched electronically, and their bibliographies examined to identify suitable studies for review and inclusion in a meta-analysis. Eligible studies were randomized controlled trials that reported data on relevant clinical outcomes. A different reviewer abstracted data for each of the three subpopulations, and one reviewer abstracted data for all three. Any differences were resolved by consensus or by consulting a fourth reviewer.ResultsIn people on CSII, rapid-acting Insulin analogs lowered postprandial plasma glucose post-breakfast to a greater extent than did regular human Insulin (RHI) (mean difference: − 1.63 mmol/L [95% confidence interval − 1.71; − 1.54]), with a comparable risk of hypoglycemia and a trend for lower glycated hemoglobin. In the pediatric population, glycemic control was similar with rapid-acting Insulin analogs and RHI, with no safety concerns. Meta-analysis indicated severe hypoglycemic events were comparable for rapid-acting Insulin analogs versus RHI (risk difference: 0.00 [95% confidence interval − 0.01; 0.01]). In the pregnancy group, Insulin lispro and Insulin aspart were safe and effective for both mother and fetus, with glycemic control being at least as good as with RHI. There were no data on Insulin Glulisine during pregnancy.ConclusionRapid-acting Insulin analogs appear generally safe and effective in these special populations; however, additional trials would be helpful.FundingNovo Nordisk A/S.
K Ways - One of the best experts on this subject based on the ideXlab platform.
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optimized basal bolus Insulin regimens in type 1 diabetes Insulin Glulisine versus regular human Insulin in combination with basal Insulin glargine
Endocrine Practice, 2005Co-Authors: S K Garg, Julio Rosenstock, K WaysAbstract:OBJECTIVE: To compare the efficacy and safety of Insulin Glulisine (GLU), a new rapid-acting Insulin analogue, injected 0 to 15 minutes before or immediately after meals, with regular human Insulin (RHI), injected 30 to 45 minutes before meals. METHODS: Patients with type 1 diabetes (N = 860) received once-daily Insulin glargine and subcutaneous injections of either GLU (premeal or postmeal) or premeal RHI in this open-label, randomized, controlled, multicen-ter, parallel-group, 12-week study. RESULTS: Baseline to endpoint changes in mean gly-cated hemoglobin (as A1c equivalents) (A1c) occurred in the premeal GLU, postmeal GLU, and premeal RHI groups (-0.26%, -0.11%, and -0.13%, respectively). The reduction in A1c was greater for the premeal GLU group in comparison with the RHI group (P = 0.02) and the post-meal GLU group (P = 0.006); no significant between-treatment difference was found for postmeal GLU versus RHI. Overall, blood glucose profiles were similar in all 3 treatment groups but were significantly lower for premeal GLU 2-hour postbreakfast measurements (premeal versus postmeal GLU, P = 0.0017; premeal GLU versus RHI, P = 0.0001) and 2-hour postdinner measurements (premeal GLU versus RHI, P = 0.0001; premeal versus postmeal GLU, P = 0.0137). Severe hypoglycemic episodes were comparable for premeal GLU, postmeal GLU, and pre-meal RHI groups (8.4%, 8.4%, and 10.1%, respectively). Body weight increased (+0.3 kg) in the RHI and premeal GLU groups; however, weight decreased in the postmeal GLU group (-0.3 kg; between-treatment difference, P = 0.03). CONCLUSION: Better A1c reductions were obtained with premeal GLU, but postmeal administration of GLU was as safe and effective as premeal GLU or RHI in combination with Insulin glargine and was not associated with weight gain.