The pursuit of an optimal prandial insulin

  • This is a sponsored symposium organised by Novo Nordisk

    Prescribing information will be made available during the meeting

     

     

    Type 1 diabetes is a common chronic disease of childhood and adolescence. In 2017, more than 40,000 children were living with type 1 diabetes in the UK alone, and this number is predicted to rise.1 The continuous improvement in long term glycemic control, management of hypoglycemia risk, and dosing flexibility with intensified insulin therapy is imperative in children and adolescents. There is an unmet need for exogenous insulin to more closely mimic normal pancreatic physiology as closely as possible in children and adolescents. 2 Fast-acting insulin aspart (Fiaspq) has previously demonstrated to be an effective treatment for glycemic control for adults living with Type 1 diabetes in the ONSET 1 study.3 This symposium looks at the results of the recently published ONSET 7 study to compare meal time insulin aspart (NovoRapid) against faster-acting insulin aspart (Fiasp) at meal time and 20 minutes post-meal in children and adolescents with Type 1 diabetes.

     

    In this symposium we shall:

    • Discuss the flexible use of fast-acting aspart in type 1 diabetes
    • Understand the contribution of post prandial glucose to overall glycaemia
    • Evaluate the clinical evidence for the use Fast acting aspart in patients with type 1 diabetes .

     

    1. International Diabetes Federation. IDF Diabetes Atlas Eight Edition: global fact sheet [Internet], 2017. Available from http://diabetesatlas.org/resources/2017-atlas.html
    2. Danne T, Phillip M, Buckingham BA, et al. ISPAD Clinical Practice Consensus Guidelines 2018: insulin treatment in children and adolescents with diabetes. Pediatr Diabetes 2018; 19(Suppl. 27):115–135
    3. Russell-Jones D, Bode BW, De Block C, et al. Fast-acting insulin aspart improves glycemic control in basal-bolus treatment for type 1 diabetes: results of a 26-week multicenter, active-controlled, treat-to-target, randomized, parallel-group trial (onset 1). Diabetes Care 2017;40:943–950

     

    Job Code: UK19DI00284    September 2019

     

    Fiasp®

    Insulin aspart

    Fast-acting insulin aspart

     

    All presentations contain insulin aspart 100 units/ml:

    Fiasp® solution for injection in pre‑filled pen (FlexTouch®)

    Fiasp® solution for injection in cartridge (Penfill®)

    Fiasp® solution for injection in vial

     

    Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

    Posology and administration: Mealtime insulin for subcutaneous administration up to 2 minutes before start of meal, with the option/flexibility to administer up to 20 minutes after starting the meal in situations when there is uncertainty about the meal intake (see section 5.1 of The Summary of Product Characteristics). Dosing is individualised and based on patient’s need.Given by subcutaneous injection, it should be used in combination with intermediate or long-acting insulin. In a basal-bolus treatment approximately 50% of this requirement may be provided by Fiasp®. Blood glucose monitoring and dose adjustments are recommended to achieve optimal glycaemic control. Fiasp® given alone can be used for continuous subcutaneous insulin infusion (CSII) in pumps and will cover both the bolus insulin requirement (approximately 50%) and basal insulin. CSII administration should preferably be in the abdomen, infusion sites should be rotated. Fiasp® can be administered intravenously by healthcare professionals. Pre-filled and reusable pens are only suitable for subcutaneous injection. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used. In elderly patients, patients with renal or hepatic impairment, glucose monitoring should be intensified and dose adjusted on an individual basis. Transfer from other insulin products must be done under strict medical supervision and may result in the need for a change in dosage. The cartridge(Penfill®) and FlexTouch® are designed to be used with NovoFine® Plus, NovoFine® and NovoTwist® injection needles. Penfill® is also designed to be used with reusable insulin pen.

    Contraindications: Hypersensitivity to active substance or excipients.

    Special warnings and precautions for use: Omission of a meal, unplanned strenuous physical exercise or too high a dose in relation to insulin requirements may lead to hypoglycaemia. Patients whose blood glucose control is greatly improved may experience a change in their usual warning symptoms of hypoglycaemia. Usual warning symptoms may disappear in patients with longstanding diabetes. If hypoglycaemia occurs, it may occur earlier after an injection compared with other mealtime insulins, due to the earlier onset of action of Fiasp®. The time to onset of action must be taken into account when prescribing to patients with concomitant diseases or treatment where a delayed absorption of food might be expected.  Close monitoring of blood glucose levels is recommended, in paediatric population if administering this medicine after the start of the last meal of the day in order to avoid nocturnal hypoglycaemia.  Inadequate dosing or discontinuation of treatment may lead to hyperglycaemia and diabetic ketoacidosis, which is potentially lethal. Concomitant illness may require changes in insulin dose. Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of congestive heart failure. Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between this medicine and other insulin medicinal products. Before travelling between different time zones, the patient should seek the doctor’s advice. Hypoglycaemia may constitute a risk when driving or operating machinery. Fiasp® must not be diluted or mixed with other medicinal products except infusion fluids, as described in SmPC section 4.2.

    Fertility, pregnancy and lactation: Fiasp® can be used in pregnancy. Data from two randomised controlled clinical trials (322 + 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn when compared to soluble human insulin. Intensified blood glucose control and monitoring is recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester. After delivery, insulin requirements normally return rapidly to pre-pregnancy values. No restrictions on use during breast-feeding. Insulin treatment of the nursing mother presents no risk to baby. However, dose may need to be adjusted. No differences in animal studies between insulin aspart and human insulin regarding fertility.

    Undesirable effects: Very common (≥1/10): Hypoglycaemia. Common (≥1/100 to <1/10): Allergic skin manifestations, injection/infusion site reactions. Uncommon (≥1/1,000 to <1/100):Hypersensitivity, lipodystrophy, Not known (cannot be estimated from the available data): Anaphylactic reactions.

    The Summary of Product Characteristics should be consulted for a full list of adverse reactions.

     

    MA numbers and Basic NHS Price:

    5 x 3 ml Fiasp®FlexTouch® EU/1/16/1160/005 £30.60;

    5 x 3 ml Fiasp® Penfill® EU/1/16/1160/010 £28.31;

    1 x 10 ml Fiasp® vial EU/1/16/1160/007 £14.08

    Legal category: POM.

     

    Full prescribing information can be obtained from:

    Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA.

    Marketing Authorisation Holder: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

     

    Date last revised: August 2019.

     

    Fiasp®, Penfill®, FlexTouch®, NovoTwist® and NovoFine® are trademarks owned by

    Novo Nordisk A/S.

    NovoRapid®

    Insulin aspart.

     

    NovoRapid® 10 ml vial

    NovoRapid® Penfill®

    NovoRapid® FlexPen®

    NovoRapid® FlexTouch®

    NovoRapid® PumpCart®

    All presentations contain insulin aspart 100 units/ml.

    Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

    Posology and administration: Individual by subcutaneous injection.  It should normally be used in combination with intermediate or long-acting insulin. NovoRapid® has a faster onset of action than soluble human insulin and should generally be given immediately before a meal. When necessary NovoRapid® can be given soon after a meal. Blood glucose monitoring and dose adjustments are recommended to achieve optimal glycaemic control. In elderly patients, patients with renal or hepatic impairment, glucose monitoring should be intensified and insulin aspart dose adjusted on an individual basis. The safety and efficacy of NovoRapid® in children below 1 year of age have not been established. No data are available. Can be used in children aged 1 year and above in preference to soluble human insulin when a rapid onset of action might be beneficial. Transfer from other insulin products, may require adjustment of the NovoRapid® or basal dose. May also be used in a suitable pump system for continuous subcutaneous insulin infusion (CSII), but must not be mixed with any other insulin. NovoRapid® vial can  be administered intravenously by physicians or other healthcare staff. Pre-filled and reusable pens are only suitable for subcutaneous injection.  If administration by syringe or intravenous injection is necessary, a vial should be used. NovoRapid® PumpCart® is only for use with Accu-Chek® Insight and YpsoPump® insulin pumps. CSII should be administered in the abdominal wall. Infusion sites should be rotated. Penfill® designed to be used with Novo Nordisk insulin delivery systems. Penfill®, FlexPen® and FlexTouch® are designed to be used with NovoFine® and NovoTwist® needles.

    Contraindications: Hypersensitivity to active substance or excipients.

    Special warnings and precautions for use: Travelling between time zones may require change in the applied insulin regimen. Inadequate dosing or discontinuation of treatment may lead to hyperglycaemia and diabetic ketoacidosis, which is potentially lethal. Omission of a meal, unplanned strenuous physical exercise or too high a dose in relation to insulin requirements may lead to hypoglycaemia. Especially in children, care should be taken to match insulin doses with food intake, physical activities and current blood glucose level. Patients whose blood glucose control is greatly improved may experience a change in their usual warning symptoms of hypoglycaemia. Usual warning symptoms may disappear in patients with longstanding diabetes. If hypoglycaemia occurs, it may occur earlier after an injection compared with soluble human insulin.  Changes in early warning symptoms of hypoglycaemia may occur on transfer between different types of insulin products. The fast onset of action should be considered in patients where a delayed absorption of food might be expected.  Concomitant illness may require changes in insulin dose. Transferring to another type or brand of insulin should be done under strict medical supervision.  Patients transferred to NovoRapid® from another type of insulin may require an increased number of daily injections or a change in dose.  Injection site reactions, usually transitory, may occur; rotation of injection sites within an area reduces the risk of developing these reactions. Rarely injection site reactions may require discontinuation of NovoRapid®. Hypoglycaemia may constitute a risk when driving or operating machinery. NovoRapid® must not be diluted or mixed with other medicinal products except infusion fluids, as described in SmPC section 4.2. Cases of cardiac failure were reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination of pioglitazone and NovoRapid® is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Patients must check insulin label before each injection to avoid accidental mix-ups with other insulins. Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.

    Fertility, pregnancy and lactation: NovoRapid® can be used in pregnancy. Data from two randomised controlled clinical trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn when compared to human insulin. Intensified blood glucose control and monitoring is recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester. After delivery, insulin requirements normally return rapidly to pre-pregnancy values. No restrictions on use during breast-feeding. Insulin treatment of the nursing mother presents no risk to baby. However, dose may need to be adjusted. No differences in animal studies between insulin aspart and human insulin regarding fertility.

    Undesirable effects: Very common (≥1/10); common (≥1/100 to <1/10);   uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Very common: Hypoglycaemia; Uncommon: Refraction disorders, diabetic retinopathy with intensification may result in temporary worsening, lipodystrophy, oedema, urticaria, rash, eruptions,  injection site reactions; Rare: Peripheral neuropathy (painful neuropathy) usually reversible, may occur with rapid improvement in glycaemic control; Very rare: Anaphylactic reactions – generalised hypersensitivity reactions are potentially life-threatening. The Summary of Product Characteristics should be consulted for a full list of side effects.

    MA numbers and Basic NHS Price:

    1 x 10 ml vial EU/1/99/119/001 £14.08;

    5 x 3 ml Penfill® EU/1/99/119/003 £28.31;

    5 x 3 ml FlexPen® EU/1/99/119/009 £30.60;

    5 x 3 ml FlexTouch® EU/1/99/119/020 £32.13;

    5 x 1.6 ml PumpCart® EU/1/99/119/024 £15.10.

    Legal category: POM.

    Full prescribing information can be obtained from:

    Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA.

    Marketing Authorisation Holder: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

    Date last revised: May 2018.

     

    NovoRapid®, Penfill®, FlexPen®, FlexTouch®, PumpCart®, NovoTwist® and NovoFine® are trademarks owned by Novo Nordisk A/S.

     

*This session has been organised and funded by Novo Nordisk

Tuesday 29 October 2019

12:00 - 12:40

Primary, Community & Specialist Care

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Speakers

Dr Ramzi Ajjan
Associate Professor & Consultant in Diabetes & Endocrinology, The Leeds Teaching Hospitals NHS Trust