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Insulin detemir: less hypoglycaemia

Insulin detemir: less hypoglycaemia . Chantal Mathieu Belgium. Outline. Hypoglycaemia is an important problem Clinical data with insulin detemir (Levemir ® ) Reasons why insulin detemir reduces hypoglycaemia Conclusion . DCCT: The price for improved diabetic control – hypoglycaemia. 12.

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Insulin detemir: less hypoglycaemia

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  1. Insulin detemir: less hypoglycaemia Chantal Mathieu Belgium

  2. Outline • Hypoglycaemia is an important problem • Clinical data with insulin detemir (Levemir®) • Reasons why insulin detemir reduces hypoglycaemia • Conclusion

  3. DCCT: The price for improved diabetic control – hypoglycaemia 12 120 Rate of severe hypoglycaemia Rate of progression of retinopathy 10 8 per 100 patient years per 100 patient years 6 60 4 2 0 0 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 10 10.5 HbA1c (%) DCCT group. New Engl J Med 1993;329:977.

  4. UKPDS and hypoglycaemia Major episodes – actual therapy Any episodes – actual therapy 8 50 Conventional policy Intensive policy 40 6 30 4 Proportion of patients (%) 20 2 10 0 0 0 3 6 9 12 15 0 3 6 9 12 15 Time from randomisation (years) Time from randomisation (years) UKPDS Study Group. Lancet 1998;352:837.

  5. Hypoglycaemia in the clinical setting: Insulin detemir (Levemir®) compared with NPH

  6. Insulin detemir (Levemir®) vs. NPH with prandial insulin aspart • Objective: To compare long-term safety and efficacy of insulin detemir and NPH, on a basal-bolus regimen with mealtime insulin aspart, in subjects with type 1 diabetes Vague et al. Diabetes Care 2003;26:590-6. De Leeuw et al. Diab Obes Metab 2004; in press

  7. Study design Insulin detemir (am + bed) + meal IAsp n = 301 n = 216 NPH (am + bed) + meal IAsp n = 146 n = 99 Screening Randomisation 6 months 6 months Randomised study Extension period 0–3 weeks Vague et al. Diabetes Care 2003;26:590-96.

  8. Glycaemic control and hypoglycaemia after 6 months HbA1c at 6 months Hypoglycaemia Insulin detemir NPH 10 10 p < 0.05 Baseline 8 8 6 6 Events rate HbA1c 4 4 2 2 0 0 1 2 3 4 5 6 Titration Months of treatment period Vague et al. Diabetes Care 2003;26:590-96.

  9. Relative risk for hypoglycaemia after 6 months Vague et al. Diabetes Care 2003;26:590-96.

  10. Glycaemic control and nocturnal hypoglycaemia during 12 months’ treatment HbA1c at 12 months Insulin detemir NPH 10 1.4 Baseline 1.2 Between-group difference, p = 0.016 8 1 6 0.8 Events/patient/month HbA1c 0.6 4 0.4 2 0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Months of treatment De Leeuw et al. Diab Obes Metab 2004; in press

  11. Insulin detemir (Levemir®) in children • Objective: To compare the efficacy of insulin detemir (Levemir®) and NPH used as basal insulin in children and adolescents with type 1 diabetes Robertson et al. Diabetes 2004;53(Suppl. 2):A144.

  12. Insulin detemir vs. NPH in children with type 1 diabetes Insulin detemir once/twice-daily + mealtime insulin aspart 140 pre-pubertal + 207 pubertal children/adolescents n = 232 NPH once/twice-daily + mealtime insulin aspart n = 115 26 weeks Robertson et al. Diabetes 2004;53(Suppl. 2):A144

  13. Baseline characteristics Robertson et al. Diabetes 2004;53(Suppl. 2):A144.

  14. Glycaemia results Robertson et al. Diabetes 2004;53(Suppl. 2):A144.

  15. Reduced nocturnal hypoglycaemia with insulin detemir vs. NPH HbA1c Insulin detemir 10 NPH insulin Baseline 0.5 8 Titration Between-group difference, p = 0.011 0.4 6 0.3 Episodes per subject/2 weeks HbA1c 4 0.2 2 0.1 0.0 0 20 22 24 8 18 26 2 4 6 10 12 14 16 Week Robertson et al. Diabetes 2004;53(Suppl. 2):A144.

  16. Hypoglycaemia: Relative Risk (insulin detemir/NPH) Robertson et al. Diabetes 2004;53(Suppl. 2):A144.

  17. Hypoglycaemia study • Objective: To compare the incidence of self-recorded hypoglycaemic episodes during basal-bolus treatment with insulin detemir plus aspart versus NPH plus aspart Kolendorf et al. Diabetes 2004;53(Suppl. 2):A130.

  18. Study design Randomisation End of study Crossover IDet (morning + bedtime) + mealtime IAsp IDet (morning + bedtime) + mealtime IAsp Usual therapy n = 131 NPH (morning + bedtime) + mealtime IAsp NPH (morning + bedtime) + mealtime IAsp 16 weeks 16 weeks 2 weeks 10 weeks’ maintenance 10 weeks’ maintenance Screen 6 weeks’ titration 6 weeks’ titration Kolendorf et al. Diabetes 2004;53(Suppl. 2):A130.

  19. Glycaemia results Kolendorf et al. Diabetes 2004;53(Suppl. 2):A130.

  20. Hypoglycaemia: Relative Risk (Insulin detemir vs. NPH) Insulin detemir NPH insulin * 10 1.2 * * 18% 39% 16% 50% Baseline 1 8 Relative risk 0.8 6 0.6 HbA1c 4 0.4 2 0.2 0 0 All Major Minor All nocturnal *Between-group difference, p< 0.05 Kolendorf et al. Diabetes 2004;53(Suppl. 2):A130.

  21. Insulin detemir: Phase III clinical studies

  22. Has reduced hypoglycaemia been a consistent finding in phase III studies? Overall hypoglycaemia Nocturnal hypoglycaemia *p < 0.05 for insulin detemir vs. NPH * * * * * * * * * * *

  23. DCCT: The price for improved diabetic control – hypoglycaemia 12 120 Rate of severe hypoglycaemia Rate of progression of retinopathy 10 8 per 100 patient years per 100 patient years 6 60 4 2 0 0 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 10 10.5 HbA1c (%) DCCT group. New Engl J Med 1993;329:977.

  24. HbA1c and hypoglycaemia: Results for people with type 1 diabetes Projected correlations for overall incidence of hypoglycaemia with HbA1c in type 1 diabetes: curves of best fit Insulin detemir 200 NPH insulin 180 160 140 120 100 Risk (events/patient/year) 80 60 40 20 0 5 6 7 8 9 10 11 HbA1c Pooled data from all studies in type 1 diabetes

  25. Treat-to-target studies in type 2 diabetes Insulin-naïve type 2 diabetes patients Randomised, parallel-group Insulin detemir/glargine NPH Existing OADs continued (both groups) -2 0 12 24 Weeks Target: Fasting & pre-dinner PG ≤ 6 mmol/l (108 mg/dl) Fasting PG ≤100 mg/dl (5.6 mmol/l) Hermansen et al. EASD 2004 Poster 754:PS 64.Riddle et al.Diabetes Care 2003;26:3080-6.

  26. Insulin glargine vs. NPH in treat-to-target trial: HbA1c and hypoglycaemia 18 21%risk reduction p <0.02 16 14 9.0 NPH + OAD Insulin glargine + OAD 12 8.5 10 Events per patient per year 8.0 42%risk reduction p <0.01 8 HbA1c (%) 7.5 6 7.0 4 6.5 2 0 0 4 8 12 16 20 24 Overall Nocturnal Hypoglycaemia Weeks Riddle et al. Diabetes Care 2003;26:3080-6.

  27. Insulin detemir vs. NPH in treat-to-target trial: HbA1c and hypoglycaemia 18 16 47%risk reduction p < 0.001 14 9.0 NPH + OAD Insulin detemir + OAD 12 8.5 10 Events per patient per year 8.0 8 HbA1c (%) 7.5 55%risk reduction p < 0.001 6 7.0 4 6.5 2 0 24 Overall Nocturnal 0 12 -2 Hypoglycaemia Weeks Hermansen et al. EASD 2004 Poster 754:PS 64.

  28. Insulin detemir (n = 237) NPH (n = 238) **p < 0.001 2000 ** 1688 1600 Hypoglycaemia (number of events) 1200 908 800 400 0 All More than 70% of patients reached HbA1c ≤ 7.0% but hypoglycaemia was lower with insulin detemir Hermansen et al. EASD 2004 Poster 754:PS 64.

  29. Correlation between variability and incidence of hypoglycaemia Accepted at EASD 2004 as Poster 841:PS 64

  30. Overall conclusions • Improving metabolic control usually results in an increase in hypoglycaemia in patients with type 1 and type 2 diabetes • Insulin detemir results in a risk reduction of 5–55% for hypoglycaemia compared with NPH insulin in patients with type 1 and type 2 diabetes • Lower within-person variability of insulin detemir is associated with reduced risk of hypoglycaemia

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