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Int J Clin Pract 2009;63: 522–31 DOI: 10.1111/j.1742-1241.2009.02002.x

Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix ® 30) in routine care: Safety and effectiveness in patients with type 2 diabetes in the IMPROVE™ observational study.

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Int J Clin Pract 2009;63: 522–31 DOI: 10.1111/j.1742-1241.2009.02002.x

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  1. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix® 30) in routine care: Safety and effectiveness in patients with type 2 diabetes in the IMPROVE™ observational study P. Valensi, M. Benroubi, V. Borzi, J. Gumprecht, R. Kawamori, J. Shaban, S. Shah, M. Shestakova, Y. Wenying on behalf of the IMPROVE™ Study Group Expert Panel Int J Clin Pract 2009;63:522–31DOI: 10.1111/j.1742-1241.2009.02002.x

  2. What’s New • IMPROVE is the largest database on patients with type 2 diabetes ever compiled (52,419 patients enrolled from eight countries) • IMPROVE reports country-specific patient outcomes following the prescription of BIAsp 30 in three continents • IMPROVE reports patient treatment satisfaction

  3. In these slides Summary of study aim, design, end-points, demographics (see IJCP March 2009 for detailed description) Results: Global (new graphs) Results: By study country (new graphs) Summary of conclusions (see IJCP March 2009 for detailed description) Design Global results Country results Conclusions

  4. Design Study aim • To assess safety and effectiveness of BIAsp 30 prescribed in routine practice to patients with type 2 diabetes by physicians in primary and secondary care settings

  5. Design Design and patients • Open-label, non-randomised, non-interventional, observational, 26-week study • Patients with type 2 diabetes prescribed BIAsp 30 as part of routine care were eligible

  6. Design Treatment • Treating physician made decisions about BIAsp 30 dose and injection frequency, and any concomitant medication, on an individual basis • Dosing information was recorded at baseline, 3 months, and 26 weeks

  7. Design Primary end-point • Incidence of major hypoglycaemic events reported as serious adverse drug reactions (SADRs)

  8. Design Secondary end-points • Other SADRs, adverse drug reactions, rates of major and minor hypoglycaemic events • Weight change, HbA1c reduction, proportions of patients reaching HbA1c target <7.0%, fasting blood glucose (FBG), postprandial blood glucose (PPBG) after all three daily meals • Insulin dose and injection frequency • Quality of life, patient treatment satisfaction

  9. Design Patient demographics

  10. Design Patients by prestudy therapy

  11. Global results Global results • Rates of SADRs and hypoglycaemia • Effectiveness data, presented as change in: • HbA1c • FBG • PPBG (breakfast, lunch, dinner) • BIAsp 30 daily dose • Weight • Patient satisfaction

  12. Global results Serious adverse drug reactions • 98 patients (0.19%) reported a total of 110 SADRs • 15 patients were from ‘no pharmaceutical therapy’ • 62 were from OADs-only • 21 were from insulin ± OADs • Most commonly reported SADR: major hypoglycaemia (81 events in 69 patients) • Less frequent SADRs: drug hypersensitivity (<0.005% of patients), injection site reaction (<0.005%) and rash (<0.005%)

  13. Global results Major hypoglycaemia

  14. Global results Minor hypoglycaemia

  15. Global results Nocturnal hypoglycaemia

  16. Global results Change in HbA1c

  17. Global results HbA1c targets reached

  18. Global results HbA1c reduction, duration of disease, and baseline HbA1c

  19. Global results Change in FBG

  20. Global results Change in PPBG (breakfast)

  21. Global results Change in PPBG (lunch)

  22. Global results Change in PPBG (dinner)

  23. Global results Change in BIAsp 30 daily dose

  24. Global results Change in weight

  25. Global results Change in patient satisfaction

  26. Country results Results by country • Rates of hypoglycaemia • Effectiveness data, presented as change in: • HbA1c • FBG • PPBG (breakfast, lunch, dinner) • BIAsp 30 daily dose • Insulin dose (all insulins) • Weight

  27. Country results Major hypoglycaemia

  28. Country results Minor hypoglycaemia

  29. Country results Nocturnal hypoglycaemia

  30. Country results Change in HbA1c

  31. Country results HbA1c targets reached

  32. Country results Change in FBG

  33. Country results Change in PPBG (breakfast)

  34. Country results Change in PPBG (lunch)

  35. Country results Change in PPBG (dinner)

  36. Country results Change in BIAsp 30 daily dose

  37. Country results Change in dose: All insulins

  38. Country results Change in weight

  39. Conclusions Conclusions Initiating insulin with or switching insulin to BIAsp 30 in routine care in patients with type 2 diabetes resulted in: • Improved glycaemic control • Reduced major hypoglycaemia • Greater treatment satisfaction These benefits were observed across all the participating countries reported

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