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Insulin Degludec/Insulin Aspart (Degludecplus) for Type 2 Diabetes

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Insulin degludec/insulin aspart (DegludecPlus) for type 2 diabetes January 2011 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes. The National Horizon Scanning Centre Research Programme is part of the National Institute for Health Research January 2011 Insulin degludec/insulin aspart (DegludecPlus) for type 2 diabetes Target group • Type 2 diabetes mellitus: uncontrolled – second line, monotherapy or add-on therapy to oral anti-diabetes drugs (OADs). Technology description Insulin degludec/insulin aspart (DegludecPlus; NN 5401; SIAC; soluble insulin analogue combination; IDegAsp) is a combination of the long-acting basal insulin, insulin degludec, with the short-acting bolus insulin, insulin aspart. In phase III trials the combination has included 70% degludec and 30% aspart. Insulin degludec (NN1250; SIBA; soluble insulin basal analogue) is a neutral, soluble, long-acting insulin analogue intended for basal insulin treatment of diabetes mellitus. Insulin degludec forms soluble multi-hexamers upon subcutaneous (SC) injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation providing an ultra-long and steady action profile. Insulin aspart is a fast- acting, short duration analogue of human insulin, available for clinical use in the UK, and is normally used in combination with a longer-acting insulin or insulin analogue. Recognised side-effects include: variable blood glucose levels, tremour, tiredness, headache, nausea and palpitation1. In phase III clinical trials, insulin degludec/insulin aspart was administered via SC injection at an individually adjusted dose, once daily with a meal. Insulin degludec/insulin aspart is also in phase III trials for type 1 diabetes mellitus. Innovation and/or advantages If licensed, insulin degludec/insulin aspart may provide an additional injectable treatment option for this patient group who are not adequately controlled on either oral therapy or basal insulin regimens. Developer Novo Nordisk. Availability, launch or marketing dates, and licensing plans In phase III clinical trials. NHS or Government priority area This topic is relevant to the National Service Framework for Diabetes (2007). Relevant guidance 2 • NICE Technology Appraisal. Liraglutide for the treatment of type 2 diabetes. 2010 . • NICE Technology Appraisal. Guidance on the use of long-acting insulin analogues for the treatment of diabetes - Insulin glargine. 20023. • NICE Clinical Guideline. Type 2 diabetes: the management of type 2 diabetes. 20094. • NICE Clinical Guideline. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period. 20075. 6 • Clinical Knowledge Summaries. Insulin therapy - type 2 diabetes. 2010 . 7 • SIGN. Management of diabetes. 2010 . • National Collaborating Centre for Chronic Conditions. Type 2 diabetes: national clinical guideline for management in primary and secondary care (update). 20088. 2 January 2011 9 • Clinical Knowledge Summaries. Diabetes type 2 - Management. 2008 . 10 • International Diabetes Federation. Global guideline for type 2 diabetes. 2005 . Clinical need and burden of disease The prevalence of diabetes in the UK is increasing, but not accurately known, and varies with factors including age, ethnic group and social deprivation7. In England, the prevalence of diabetes (diagnosed and undiagnosed) in adults is estimated to be 7.4%11,a, which equates to 3,009,853 people above the age of 16 years10. In Wales, prevalence is estimated to be 9%b equating to 218,956 people above the age of 16 years 12. More than 85% of people with diabetes are expected to have type 2 diabetes3 and in 2009 it was estimated that there were 821,800 adults with diabetes who were not diagnosed13. Prevalence of diabetes among adults is estimated to rise to 8.5% by 2020 and 9.5% by 203012. In England in 2005, there were 26,300 deaths between the ages of 20 and 79 years which were attributable to diabetes (11.6% of all deaths in this age group)14. However, clinical coding practice means that only a minority of deaths among people with diabetes from causes that can be associated with the disease have diabetes identified as the primary cause of death13. Life expectancy is reduced by up to 10 years in this patient group15. Cardiovascular disease is a common complication of type 2 diabetes and is a significant cause of morbidity and premature death, accounting for around 60% of all deaths from diabetes16. Other long-term complications associated with diabetes include: nephropathy, retinopathy and neuropathy, leading respectively to renal failure, reduced vision or blindness and foot ulceration and amputation. Existing comparators and treatments Current treatment options include4, 8: Oral anti-diabetes drugs (alone or in combination): • Metformin. • Sulfonylureas: gliclazide, glibenclamide, glipizide, tolbutamide, glimepiride. • Alpha-glucosidase inhibitors: acarbose. • Thiazolidinediones (glitazones): rosiglitazone (EMA suspended marketing authorisation in September 2010), pioglitazone (becoming generic in 2011). • DPP-4 inhibitors: sitagliptin, vildagliptin, saxagliptin. Injectable drugs: • Exenatide (twice daily SC). • Liraglutide (once daily SC). • Insulin (human or analogue). Current practice is that treatment should aim to achieve the target glycated haemoglobin (HbA1c) level of 6.5% for the first 2 treatment steps, or 7.5% if further treatment steps are required or where there is severe risk of hypoglycaemia. Efficacy and safety Trial NCT00614055, NN5401-1791; two dose BOOST, NCT01045707, NN5401- levels of insulin degludec/insulin aspart 3590; insulin degludec/insulin aspart vs insulin glargine, all in combination vs insulin glargine, both combined with metformin; phase II. with metformin; phase III. Sponsor Novo Nordisk. Novo Nordisk. a Uncertainty limits 5.3%-10.8%. b Uncertainty limits 6.9%-11.9%. 3 January 2011 Status Complete but unpublished. Ongoing. Source of Trial registry17, oral presentation18. Trial registry19. information Location EU. EU, USA and other countries. Design Randomised, active-controlled. Randomised, active-controlled. Participants and n=178; adults; type 2 diabetes mellitus; n=529; adults; type 2 diabetes mellitus schedule insulin naïve; stable treatment regimen ≥6 months; insulin naïve; treatment of 1 or 2 OADs for ≥2 months. with metformin and 1 or 2 additional All patients receive metformin 1.5- OADs ≥3 months prior to trial entry. 2g/day. Randomised to formulation 1 Randomised to insulin (70% degludec) or 2 (55% degludec) of degludec/insulin aspart; or insulin insulin degludec/aspart SC once daily; glargine, both individually adjusted SC or insulin glargine SC once daily. All dose, once daily with morning meal. doses individually adjusted. Follow-up Active treatment period 16 weeks. Active treatment period 26 weeks. Primary HbA1c. HbA1c. outcome Secondary Plasma glucose profiles; hypoglycaemic Plasma glucose. outcome episodes; AEs. Key results HbA1c decreased from 8.4% to 7.0% in Insulin degludec/insulin aspart showed all groups. 20 hypoglycaemic episodes no inferiority in lowering HbA1c, with reported in the insulin degludec/insulin a higher rate of hypoglycaemia aspart groups and 12 in the insulin (statistically significant) and lower rate glargine group. Doses of insulin were of nocturnal hypoglycaemia compared smaller in the insulin degludec/aspart to insulin glargine. groups compared to the insulin glargine group (0.38 vs 0.45 units/kg). Adverse effects Reportedly very few, mild AEs. No reported differences between (AEs) treatment groups. Trial NCT01169766, NN5401-3726; insulin BOOST, NCT01045447, NN5401- degludec/aspart vs insulin glargine; 3593; insulin degludec/aspart vs phase III, extension to trial insulin glargine; phase III. NCT01045707. Sponsor Novo Nordisk. Novo Nordisk. Status Ongoing. Completed. Source of Trial registry20. Trial registry21. information Location EU, USA and other countries. EU, USA and other countries. Design Non-randomised, active-controlled. Randomised, active-controlled. Participants and n=335; adults; type 2 diabetes mellitus; n=465; adults; type 2 diabetes mellitus schedule completed trial NCT01045707. ≥6 months; stable treatment regimen Patients continued treatment regimen with basal insulin once daily and allocated in previous trial. All doses metformin with or without additional individually adjusted. OADs ≥3 months prior to trial entry, and continuing throughout trial. Randomised to insulin degludec/aspart; or insulin glargine, both individually adjusted SC dose, once daily with main meal. Follow-up Active treatment period 26 weeks (52 Active treatment period 26 weeks. week total). Primary AEs; hypoglycaemic episodes. HbA1c. outcome Secondary HbA1c. Plasma glucose profile. outcome 4 January 2011 Key results - Insulin degludec/aspart showed no inferiority in lowering HbA1c, higher rate of hypoglycaemia (p<0.05) and lower rate of nocturnal hypoglycaemia (p<0.05) compared to insulin glargine. Expected May 2011. - completion date Adverse effects - No reported differences between (AEs) treatment groups. Trial BOOST, NCT01059812, NN5401-3597; BOOST, NCT01009580, NN5401- insulin degludec/aspart vs biphasic 3592; insulin degludec/aspart vs insulin aspart 30; phase III. biphasic insulin aspart 30; phase III.
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