Insulin Initiation Simplifying and involving your patients in

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Insulin Initiation: Simplifying and involving your patients in their control Ehsan Shekofteh MD Novonordisk

Insulin Initiation: Simplifying and involving your patients in their control Ehsan Shekofteh MD Novonordisk

MANAGEMENT OF TYPE 2 DIABETES

MANAGEMENT OF TYPE 2 DIABETES

Mean Hb. A 1 c at last visit (%) Insulin use is often delayed,

Mean Hb. A 1 c at last visit (%) Insulin use is often delayed, despite poor glycaemic control 1, 2 10 9. 4% 9. 1% 8. 8% 9 8 3 OADs 2 OADs 1 OAD Diet 2. 9 years 4. 7 years 2. 5 years OAD, oral antidiabetic drug 1 Novo Nordisk. Type 2 Diabetes Market Research. 2 Roper Starch US Study, 2000. 2. 7 years

Insulin remains the most efficacious glucose lowering agent Hb. A 1 c % Decrease

Insulin remains the most efficacious glucose lowering agent Hb. A 1 c % Decrease in Hb. A 1 c: Potency of monotherapy Nathan et al. , Diabetes Care 2009; 32: 193 -203.

IDF Global guideline for type 2 diabetes EASD 2012 http: //www. idf. org/guidelines/type-2 -diabetes

IDF Global guideline for type 2 diabetes EASD 2012 http: //www. idf. org/guidelines/type-2 -diabetes

Novo. Mix® 30 could be a solution

Novo. Mix® 30 could be a solution

Formulation of premixes Premixed suspension of: Soluble insulin aspart 30% Soluble human insulin NPH

Formulation of premixes Premixed suspension of: Soluble insulin aspart 30% Soluble human insulin NPH Protamine-crystallised insulin aspart Novo. Mix® 30 Premixed human insulin

The dual-release insulin concept • Physiological insulin profile: basal component meal-related peaks • •

The dual-release insulin concept • Physiological insulin profile: basal component meal-related peaks • • Rapid-acting insulin analogues together with a basal insulin provide physiological insulin replacement Premix analogues such as Novo. Mix® 30 replace both meal-related and basal insulin Physiological insulin profile Soluble insulin aspart Protamine crystallised insulin aspart Novo. Mix® 30

Glycaemic control

Glycaemic control

A wealth of data from RCTs and real-world experiences • RCTs: INITIATE, Euro. Mix,

A wealth of data from RCTs and real-world experiences • RCTs: INITIATE, Euro. Mix, ACTION, ONCEMix • Total number of patients: 1121 • Clinical evidence that BIAsp 30 improves Hb. A 1 c, FPG, PPG and rates of hypoglycaemia, with simple intensification • Observational studies • 1 -2 -3 (n=100) • PRESENT (n=21, 977), IMPROVETM (n=52, 419), A 1 chieve (n=66, 726) • Clinical experience evaluation studies • Data from the real-world setting • Patients coming from a wide variety of different therapies Raskin et al. Diabetes Care 2005; 28: 260– 5; Kann et al. Exp Clin Endo Diab 2006; 114: 527– 32; Raskin et al. Diabetes Obes Metab 2009; 11: 27– 32; Strojek et al. CMRO 2009; 25: 2887– 94; Garber et al. Diabetes Obes Metab 2006; 8: 58– 66; Khutsoane et al. Diabetes Obes Metab 2008; 10: 212– 22; Valensi et al. Int J Clin Pract 2009; 63: 522– 31; Home et al. Diabetes Res Clin Pract. 2011; 94: 352– 63

Comparable Hb. A 1 c reduction between RCTs and observational studies 10. 0 9.

Comparable Hb. A 1 c reduction between RCTs and observational studies 10. 0 9. 7% 9. 5 9. 2% 9. 0 8. 6% 8. 5 8. 1% 8. 0 7. 5% 7. 1% 7 A 1 ch iev E OV PR ES EN T 6 IM Ga rb er 1 - 2 - 3 3 ON TI AC ix 2 ro M Eu IN IT IA T E 1 0. 0 e 8 6. 6% 6. 5% PR 6. 5 7. 3% 7. 1% al. 5 6. 9% et 7. 0 ON CE Mi x 4 Hb. A 1 c (%) 9. 5% 9. 3% 1. Raskin et al. Diabetes Care 2005; 28: 260– 5; 2. Kann et al. 5. Garber et al. Diabetes Obes Metab 2006; 8: 58– 66; 6. Khutsoane Exp Clin Endo Diab 2006; 114: 527– 32; 3. Raskin et al. Diabetes et al. Diab Obes Metab 2008; 10: 212– 22; 7. Valensi et al. Int J Clin Obes Metab 2009; 11: 27– 32; 4. Strojek et al. CMRO 2009; Pract 2009; 63: 522– 31; 8. Home et al. Diabetes Res Clin Pract. 25: 2887 -94 2011; 94: 352 -63.

Comparable FPG reduction between RCTs and observational studies 14. 0 14 250 13 11.

Comparable FPG reduction between RCTs and observational studies 14. 0 14 250 13 11. 0 11 11. 1 10. 9 9. 8 9. 6 10 9. 2 9 150 8. 6 0 1 ch iev e 8 100 A 7 x 4 ON CE Mi 3 ON AC TI ix 2 o. M Eu r IN IT IA TE 1 0 6. 6 6. 4 OV E 6. 8 6 7. 1 PR 7. 2 IM 7. 1 1 rb 2 -3 er et al. 5 PR ES EN T 6 7 Ga 8 200 FPG (mg/d. L) FPG (mmol/L) 12 1. Raskin et al. Diabetes Care 2005; 28: 260– 5; 2. Kann et al. 5. Garber et al. Diabetes Obes Metab 2006; 8: 58– 66; 6. Khutsoane Exp Clin Endo Diab 2006; 114: 527– 32; 3. Raskin et al. Diabetes et al. Diab Obes Metab 2008; 10: 212– 22; 7. Valensi et al. Int J Clin Obes Metab 2009; 11: 27– 32; 4. Strojek et al. CMRO 2009; Pract 2009; 63: 522– 31; 8. Home et al. Diabetes Res Clin Pract. 25: 2887 -94 2011; 94: 352 -63.

17 16 15 14 13 12 11 10 9 8 7 0 Breakfast 16.

17 16 15 14 13 12 11 10 9 8 7 0 Breakfast 16. 9 Dinner 16. 2 Breakfast 15. 6 Breakfast 15. 1 Breakfast 13. 7 Dinner 12. 3 300 265 Dinner 12. 6 230 195 8. 7 9. 1 9. 8 8. 9 8. 0 INITIATE 1 Euro. Mix 2 90 min after meals 8. 6 7. 9 IMPROVE 3 A 1 chieve 4 2 h after meals 1. Raskin et al. Diabetes Care 2005; 28: 260– 5; Kann et al. Exp Clin Endo Diab 2006; 114: 527– 32; Valensi et al. Int J Clin Pract 2009; 63: 522– 31; Home et al. Diabetes Res Clin Pract. 2011; 94: 352 -63 160 125 0 PPG (mg/d. L) PPG (mmol/L) Comparable PPG reduction can be achieved with BIAsp 30

Hypoglycaemia & modern insulin Do modern insulins offer any advantages over traditional insulins?

Hypoglycaemia & modern insulin Do modern insulins offer any advantages over traditional insulins?

Results of safety meta-analysis on hypoglycaemia • The meta-analysis population comprised 1674 patients with

Results of safety meta-analysis on hypoglycaemia • The meta-analysis population comprised 1674 patients with type 2 diabetes (48% Caucasians and 49. 5% Asians) • n=810 were exposed to BIAsp 30; 524 to BHI 30; and 340 to both treatments (in crossover studies) • The two treatment groups were closely matched with respect to demographic and baseline characteristics • Patient demographics at baseline, mean (SD): • 57% male • Age 61 (± 10. 6) years • BMI 26. 7 (± 4. 6) kg/m 2 • Hb. A 1 c 8. 1 (± 1. 4) % • Duration of diabetes 10. 9 (± 7. 9) years Davidson et al. Clin Ther 2009; 31: 1641– 51

BIAsp 30 is associated with a significantlylower rate of major hypoglycaemia than BHI 30

BIAsp 30 is associated with a significantlylower rate of major hypoglycaemia than BHI 30 Odds ratios are calculated by the fixed effects model Odds ratio [95% CI] Trial 038 0. 50 [0. 12; 1. 98], p=0. 32 1234 0. 34 [0. 01; 8. 28], p=0. 50 1353 0. 57 [0. 16; 2. 00], p=0. 38 1394 0. 53 [0. 03; 8. 63], p=0. 66 1466 0. 31 [0. 06; 1. 54], p=0. 15 3002 0. 25 [0. 01; 6. 62], p=0. 41 Overall 0. 45 [0. 22; 0. 93], p<0. 05 Test of heterogeneity: I 2 = 0% 0. 1 0. 2 Favours BIAsp 30 1 10 Favours BHI 30 20 Overall: all data for all trials combined Adapted from Davidson et al. Clin Ther 2009; 31: 1641– 51

BIAsp 30 is associated with a significantly-lower rate of nocturnal hypoglycaemia than BHI 30

BIAsp 30 is associated with a significantly-lower rate of nocturnal hypoglycaemia than BHI 30 Rate ratios are calculated by the fixed effects model Trial Rate ratio [95% CI] 038 1088 1234 0. 57 [0. 20; 1. 58], p=0. 28 0. 89 [0. 25; 3. 16], p=0. 86 0. 44 [0. 22; 0. 89], p=0. 02 1353 1394 1. 03 [0. 42; 2. 53], p=0. 95 1. 03 [0. 38; 2. 76], p=0. 96 1466 0. 33 [0. 21; 0. 51], p<0. 01 1536 0. 44 [0. 11; 1. 47], p=0. 17 3002 1. 05 [0. 11; 10. 09], p=0. 97 3006 2. 43 [0. 31; 18. 90], p=0. 39 Overall Test of heterogeneity: I 2 = 32% 0. 50 [0. 38; 0. 67], p<0. 01 0. 2 Favours BIAsp 30 1 10 Favours BHI 30 20 Overall: all data for all trials combined Adapted from Davidson et al. Clin Ther 2009; 31: 1641– 51

How to Start with Novo. Mix® 30

How to Start with Novo. Mix® 30

Start and stay with Novo. Mix® 30 1. 2. 3. Novo. Mix® 30 Summary

Start and stay with Novo. Mix® 30 1. 2. 3. Novo. Mix® 30 Summary of Product Characteristics. Garber A et al. The 1 -2 -3 study. Diabetes, Obesity and Metabolism 2006; 0: 1– 10. Raskin P et al. On behalf of the INITIATE Study Group. Basal insulin or premix analogue therapy in type 2 diabetes patients. Euro J Int Med 2007; 18: 56– 62.

Timing of pre-meal blood glucose measurement and dose titration 1 x daily Measure Breakfast

Timing of pre-meal blood glucose measurement and dose titration 1 x daily Measure Breakfast 2 x daily Measure BG BG Lunch Measure BG Breakfast Dinner BG Lunch Dinner Breakfast Lunch Measure BG Breakfast Dinner BG Lunch Dinner

How to Intensify with Novo. Mix® 30

How to Intensify with Novo. Mix® 30

Switching from basal insulin OD or BID to BIAsp 30 BID • • 1:

Switching from basal insulin OD or BID to BIAsp 30 BID • • 1: 1 total dose transfer to BIAsp 30 • • Titrate the dose preferably once a week • • Continue metformin • Administer BIAsp 30 just before meals Split the dose 50: 50 pre-breakfast and pre-dinner Discontinue sulphonylureas Consider discontinuing TZDs as per local guidelines and practice Unnikrishnan et al. Int J Clin Pract 2009; 63: 1571– 7

How to Upgrade with Novo. Mix® 30

How to Upgrade with Novo. Mix® 30

Patients treated with regular and NPH insulin with 20/80, 30/70 and 40/60 proportions Poor

Patients treated with regular and NPH insulin with 20/80, 30/70 and 40/60 proportions Poor glycaemic control Controlled but history of hypoglycemia Good glycemic control and no history of hypoglycemia Switch to NM 30 with 10% increasing dose (the summation of both Regular and NPH doses) Switch to NM 30 with 10% decreasing dose (the summation of both Regular and NPH doses) Switch to NM 30 with equvalent dose (the summation of both Regular and NPH doses) Practical Guideline on Switching from Biphasic Human Insulin to Novo. Mix® 30, not published yet

THANK YOU

THANK YOU