Quality of life improves after patients switch to biphasic insulin aspart 30/70 (BIAsp 30): IMPROVE™ Study data from 39,015 patients M. Benroumpi 1, T. Christensen 2, J. Gumprecht 3 1 Diabetes Centre, General Hospital of Athens "POLYKLINICI", Athens, Greece. 2 Global Health Economics and Outcomes Research, Novo Nordisk A/S, Bagsvaerd, Denmark. 3 Department of Internal Diseases, Silesian School of Medicine, Zabrze, Poland. MGSD IMPROVE global data cut March 2008

2 Agenda IMPROVE™ study design Objectives for this analysis Methods –Diabetes Medication Satisfaction Questionnaire –Patients Results Conclusion MGSD IMPROVE global data cut March 2008

3 Study design - Design overview HbA1c FBG PPG Hypoglycemic events Insulin dose Weight (BMI) Patient treatment satisfaction – Quality of Life Physician resource utilization To evaluate the incidence of major hypoglycaemic events reported as serious adverse drug reactions. during 26 weeks of biphasic insulin aspart (NovoMix®30) therapy Post-Authorization Safety Study Open label. non- randomized, observational 6-month Patients are own control group Hypothesis-generating Adhere to local & EMEA guidelines Where possible, inclusion of only OAD failure patients Study design Primary endpoints Secondary endpoints MGSD IMPROVE global data cut March 2008

Significant reduction of HbA 1c HbA1c [%] * p<0.001 Baseline Final visit Mean HbA 1c % Data on file

No significant change of minor hypoglycaemia HbA1c [%] events/patient year Baseline Final visit Data on file

6 Methods MGSD IMPROVE global data cut March 2008 Design of the DiabMedSat questionnaire Diabetes Medication Satisfaction Questionnaire (DiabMedSat) has been validated 1 The Diab-MedSat questionnaire measures the patients treatment satisfaction over the past two weeks The Diab-MedSat measure is scored as an overall score (all 21 items) as well as three subscale scores regarding –Burden (11 items: Q1, Q4a, Q5abc, Q6abc) –Symptoms (5 items: Q2) –Efficacy (5 items: Q3, Q4bc, Q5d) The overall score is computed as the mean of the three subscale scores All scores are transformed on a point scale with higher scores indicating greater satisfaction 1 Brod M e t al. Qual Life Res Apr;15(3):

7 Objectives MGSD IMPROVE global data cut March 2008 Quality of life investigation For the cohort consisting of patients from (mainly) China and India, and from Canada, Japan and Poland changes in quality of life were investigated by treatment satisfaction as measured with the validated Diabetes Medication Satisfaction Questionnaire before and after treatment with BIAsp 30 Only patients with pre-study treatment were included Analyses were done for the total cohort, and divided by pre-study therapy: OAD only or insulin ± OADs

8 Methods - Patients by pre-study therapy and country Insulin ± OADsOAD aloneTotal Canada China India Japan Poland03656 Russia Total MGSD IMPROVE global data cut March 2008

9 Insulin +/- OADOAD alone Number enrolled Mean age ± SD (years)57.1 ± ± 11.6 Gender, M/F (%)55/4557/43 Mean weight ± SD (kg)72.54 ± ± Mean BMI ± SD (kg/m 2 )26.97 ± ± 4.63 Mean diabetes duration ± SD (years)10.16 ± ± 5.36 Mean HbA 1c ± SD (%)9.29 ± ± 1.77 Results - Overview of baseline characteristics by pre-study therapy MGSD IMPROVE global data cut March 2008

*** 11.9 *** 10.9 *** 28.0 *** NS=Not Significant *) p<0.05 **) p<0.01 ***) p<0.001 Results - QoL for total cohort of all pre-study treated MGSD IMPROVE global data cut March 2008

*** 14.5*** NS=Not Significant *) p<0.05 **) p<0.01 ***) p<0.001 Results - QoL by pre-study therapy MGSD IMPROVE global data cut March *** 11.7***11.2 *** 8.4***28.6 *** 23.2*** Overall score Burden Symptoms Efficacy

12 Results - Distribution of Q7. Total cohort MGSD IMPROVE global data cut March 2008 Overall, thinking about each of the aspects of your diabetes medication(s) mentioned above, how DISSATISFIED or SATISFIED have you been with your current diabetes medication(s)?

13 Conclusions MGSD IMPROVE global data cut March 2008 Applying the DiabMedSat to 39,015 patients included in the IMPROVE™ study revealed that treatment with BIAsp 30 over 26 weeks significantly improved patient satisfaction (reflected in the mean overall score) Significant improvements in the relief of burden, relief of symptoms, and effectiveness domains were achieved Although the highest score was observed in the relief of symptoms domain, the greatest improvement was seen in the effectiveness domain, which in turn should enhance patient satisfaction, promote treatment adherence and self- management, ultimately leading to improvements in glycaemic control All improvements were judged as clinically relevant