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Biphasic insulin aspart 30 + metformin vs once-daily insulin glargine + glimepiride

Biphasic insulin aspart 30 + metformin vs once-daily insulin glargine + glimepiride. Kann P, Regulski M, Medding J, Ligthelm R. A study in people with type 2 diabetes. Introduction. In patients failing on oral antidiabetic (OAD) medication, insulin therapy is frequently started by adding:

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Biphasic insulin aspart 30 + metformin vs once-daily insulin glargine + glimepiride

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  1. Biphasic insulin aspart 30 + metformin vs once-daily insulin glargine + glimepiride Kann P, Regulski M, Medding J, Ligthelm R A study in people with type 2 diabetes

  2. Introduction • In patients failing on oral antidiabetic (OAD) medication, insulin therapy is frequently started by adding: • a basal insulin, or • a premixed insulin preparation.

  3. Insulin analogues – insulin aspart Pro Asp Phe Gly Arg Phe Tyr Glu Thr Gly Asp B30 Cys B28 Lys Thr A21 Asn Cys Val Tyr Leu A1 Gly Asn Tyr Ile Glu Leu Val Leu Ala Glu Gln Glu Gln Tyr Val Cys Leu Ser Cys Thr Ser Ile Leu Cys His Ser Gly Cys Leu B1 Phe Val Asn Gln His

  4. Insulin analogues Biphasic insulin aspart 30 comprises: 30% soluble, rapid-acting insulin aspart • 70% protaminated insulin aspart, which is intermediate-acting

  5. Insulin analogues • Insulin glargine • long-acting human insulin analogue • structural changes delay absorption • allows a relatively constant basal insulin supply following subcutaneous injection

  6. Insulin glargine Phe Gly Arg Phe Tyr Glu Thr Gly Pro A21 B30 Cys Lys Thr Cys Val Gly Tyr Arg Leu Asn A1 Gly Asn Arg Tyr Ile Glu Leu Val Leu Ala Glu Gln Glu Gln Tyr Val Cys Leu Ser Cys Thr Ser Ile Leu Cys His Ser Gly Cys Gly Leu B1 Phe Val Asn Gln His

  7. Aim • The objective of this study was to compare efficacy and tolerability of two start-up insulin regimens in patients with type 2 diabetes failing on OADs

  8. Trial design Randomised, open-label, parallel study BIAsp 30 twice daily + metformin (BIAsp/met) Insulin glargine once daily + glimepiride (Glargine/glim) 2-week screeningperiod 20-week treatment period 6-week titrationperiod

  9. Study endpoints Primary • HbA1c after 26 weeks Secondary • HbA1c after 16 weeks • Prandial increment in plasma glucose • Fasting plasma glucose • 7-point plasma glucose profiles • Body Mass Index Safety

  10. Patient characteristics All values are mean ± SD unless stated otherwise

  11. Greater reduction in HbA1c with BIAsp/met than Glarg/glim BIAsp/met Glarg/glim -0.5% p=0.0002 Reduction from baseline to end-of-trial

  12. Lower HbA1c after 26 weeks with BIAsp 30/met than Glarg/glim HbA1c (%) p=0.01

  13. Greater reduction in HbA1c with BIAsp/met than Glarg/glim after 16 weeks -0.5% p=0.0001 D HbA1c (%) Reduction from baseline to week 17

  14. Percentage of patients achievingHbA1c < 7% Patients at target (%)

  15. Absolute change of FPG after 26 weeks FPG (mmol/l) p=0.23

  16. 7-point PG profile at trial end

  17. Absolute change in PG from baseline

  18. Mean prandial increment in PG Change from baseline in mean prandial PG increment p=0.0002 p<0.0001 Mean prandial PG increment at EOT

  19. Overall hypoglycaemia during treatment

  20. BIAsp/met Glargine/glim Baseline End of trial BMI and weight change * BIAsp/met Glargine/glim * Significant change from baseline (95% CI: 0.81; 2.2)

  21. End of trial treatment doses

  22. Results summary • Compared with Glarg/glim, BIAsp 30/met: • improved glycaemia to a greater extent • was associated with same number of major hypoglycaemia (1 event) but more minor hypoglycaemia • had no significant effect on weight

  23. Conclusions • Adding insulin to type 2 patients failing with OAD can improve glycaemic control • BIAsp/met may be a more preferable option to Glarg/glim when initiating insulin in patients with type 2 diabetes

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