Insulin Initiation With NovoMix30 Masoud Rahmanian MD

Need for treatment intensification Over 50% of T2D patients require insulin after 6 years Bergenstal 2001; Wright 2002 2

Current diabetes targets and guidelines Insulin therapy with NovoMix® 30 Current diabetes targets and guidelines 26 April, 2017

HbA1c targets are converging Insulin therapy with NovoMix® 30 Good glycaemic control ADA/EASD consensus HbA1c <7% IDF HbA1c≤ 7.0% CDA (Canada) HbA1c ≤7% AACE (USA) HbA1c≤ 6.5% Although the HbA1c targets recommended by international and national diabetes management guidelines are starting to converge, only a third of patients are achieving good glycemic control. Note the important role of clinical judgement to determine which patients can reasonably and safely achieve their glycemic targets. Consideration should be given to individual risk factors such as the patient’s age, prognosis, the presence of diabetes complications or co-morbidities and the patient’s risk for, and ability to recognize, symptoms of hypoglycemia. NICE (UK) HbA1c 6.5-7.5% 26 April, 2017 5

Individualising HbA1c goals Insulin therapy with NovoMix® 30 Individualising HbA1c goals Psycho- Patient-centred care Bio- -social 26 April, 2017 Inzucchi et al. Diabetes Care 2012;35:1364–79

Yet good glycaemic control is not achieved Insulin therapy with NovoMix® 30 Yet good glycaemic control is not achieved HbA1c (%) 10.0 12.4% have HbA1c>10.0 % 9.5 20.2% have HbA1c>9.0 % 9.0 8.5 37.2% have HbA1c>8.0 % 8.0 7.5 64.2% of patients with type 2 diabetes have HbA1c≥7.0 % 7.0 6.5 6.0 5.5 Adapted from Unger et al. Am J Med 2008;121:S3–S8. 26 April, 2017 7

Current glycaemic targets Insulin therapy with NovoMix® 30 Current HbA1c goals include: ADA, EASD, IDF: <7% AACE, JDS: ≤6.5% Current pre- and postprandial glucose goals include: Pre-meal: 90–130 mg/dL PeakPP: <180 mg/dL ADA Pre-meal: <110 mg/dL 1–2-h peak: <160 mg/dL IDF 26 April, 2017 AACE, American Association of Clinical. Endocrinologists; JDS, Japan Diabetes Society

Insulin Initiation Basal Premixed Basal- bolus

Analogue versus human insulin

Formulation of premixes Insulin therapy with NovoMix® 30 Formulation of premixes 30% Protamine-crystallised insulin aspart Soluble insulin aspart Premixed suspension of: Soluble human insulin NPH NovoMix® 30 Premixed human insulin 26 April, 2017

Increasing complexity of insulin regimens Insulin therapy with NovoMix® 30 Increasing complexity of insulin regimens: Basal insulin alone is usually the optimal initial regimen, beginning at 0.1-0.2 U/kg body weight, depending on the degree of hyperglycemia. It is usually prescribed in conjunction with 1-2 non-insulin agents (OGLDs). In patients willing to take >1 injection and who have higher A1c levels (≥9.0%), BID pre-mixed insulin or a more advanced basal plus mealtime insulin regimen could also be considered (curved dashed arrow lines). When basal insulin has been titrated to an acceptable FPG but A1c remains above target, consider proceeding to basal + meal-time insulin, consisting of 1-3 injections of rapid-acting analogues. A less studied alternative—progression from basal insulin to a twice daily pre-mixed insulin—could be also considered (straight dashed arrow line); if this is unsuccessful, move to basal + mealtime insulin. The figure describes the number of injections required at each stage, together with the relative complexity and flexibility. Once a strategy is initiated, titration of the insulin dose is important, with dose adjustments made based on the prevailing BG levels as reported by the patient. Non-insulin agents may be continued, although insulin secretagogues (sulfonylureas, meglitinides) are typically stopped once more complex regimens beyond basal insulin are utilized. Comprehensive education regarding self-monitoring of BG, diet, exercise, and the avoidance of, and response to, hypoglycemia are critical in any patient on insulin therapy. ADA/EASD Position Statement. Diabetologia Online; 24 February 2012 26 April, 2017

NovoMix® 30 is a solution Insulin therapy with NovoMix® 30 26 April, 2017

Diabetes Care 2013 Insulin therapy with NovoMix® 30 26 April, 2017

Diabetes Care 2013 Insulin therapy with NovoMix® 30 26 April, 2017

CONCLUSION: Biphasic and basal bolus regimens were equally effective in reducing HbA1c in insulin naïve patients with T2DM and both regimens are equally effective for initiating insulin in T2DM. Wang C1, Mamza J, Idris I. Diabetic Medicine. 2015 Jan 16

NovoMix®30 or Mixed Human Insulin Insulin therapy with NovoMix® 30 26 April, 2017

The dual-release insulin concept: BHI 30 Insulin therapy with NovoMix® 30 The dual-release insulin concept: BHI 30 Physiological insulin profile: basal component meal-related peaks Physiological insulin profile …together these fail to re-create the physiological insulin profile BHI 30 Soluble insulin fails to match normal insulin peak Soluble human insulin Intermediate-acting insulin provides basal insulin replacement but… NPH 26 April, 2017 18

The dual-release insulin concept Insulin therapy with NovoMix® 30 The dual-release insulin concept Physiological insulin profile: basal component meal-related peaks Physiological insulin profile Premix analogues such as NovoMix® 30 replace both meal-related and basal insulin NovoMix® 30 Rapid-acting insulin analogues together with a basal insulin provide physiological insulin replacement Soluble insulin aspart Protamine crystallised insulin aspart 26 April, 2017 19

Benefits of analogue mix insulin NovoMix® 30 provides significantly greater PPG control than BHI 30 and insulin glargine 50% more people reach recommended HbA1c target with NovoMix® 30 than insulin glargine NovoMix® 30 is a convenient way to start insulin, with a simple dosing guideline and the easy-to-use FlexPen® Insulin therapy with NovoMix® 30 26 April, 2017

Insulin therapy with NovoMix® 30 Overall hypoglycaemia rate following switch from biphasic human insulin to biphasic aspart n=6323 In addition, overall hypoglycaemia decreased from 6.0 events/patient-year at baseline to 2.1 events/patient-year at Week 24. 26 April, 2017 El Naggar et al. Diabetes Res Clin Pract 2012;98:408–13

Diabetes Care 2013 Insulin therapy with NovoMix® 30 26 April, 2017

Insulin therapy with NovoMix® 30 26 April, 2017

Intensifying from BIAsp 30 BID to TID BIAsp, biphasic insulin aspart; BID, twice daily; OD, once daily; TID, three-times daily; TZDs, thiazolidinediones Unnikrishnan et al. Int J Clin Pract 2009;63:1571–7

Conclusion NovoMix® 30: Insulin therapy with NovoMix® 30 26 April, 2017

NovoMix® 30 Improve Glycaemic Control Improve Safety Profile Insulin therapy with NovoMix® 30 NovoMix® 30 Improve Glycaemic Control Improve Safety Profile Improve Convenience In one Insulin, one Device 26 April, 2017

“Always aim at complete harmony of thought and word and deed” Insulin therapy with NovoMix® 30 “Always aim at complete harmony of thought and word and deed” Gandhi Aim at complete harmony Patient and Physician and Prescription 26 April, 2017

Any Question? Insulin therapy with NovoMix® 30 26 April, 2017