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

Quality of life improves after patients switch to biphasic insulin aspart 30/70 (BIAsp 30): IMPROVE™ Study data from 39,015 patientsM. Benroumpi1, T. Christensen2, J. Gumprecht3

1Diabetes Centre, General Hospital of Athens "POLYKLINICI", Athens, Greece. 2Global Health Economics and Outcomes Research, Novo Nordisk A/S, Bagsvaerd, Denmark.3Department of Internal Diseases, Silesian School of Medicine, Zabrze, Poland.

MGSD 2009 - IMPROVE global data cut March 2008

2

Agenda

• IMPROVE™ study design

• Objectives for this analysis

• Methods

– Diabetes Medication Satisfaction Questionnaire

– Patients

• Results

• Conclusion


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


Significant reduction of HbA1cH

bA

1c

[%]

* p<0.001

Baseline

Final visit

9,4

7,0

6

7

8

9

10

Global cohort

Mean H

bA

1c %

Data on file

No significant change of minor hypoglycaemia

HbA

1c

[%]

2,26 2,80

0

1

2

3

4

Global cohort

events

/pati

ent

year

Baseline

Final visit

Data on file

6

Methods


Design of the DiabMedSat questionnaire

• Diabetes Medication Satisfaction Questionnaire (DiabMedSat) has been validated1

• 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 0-100 point scale with higher scores indicating greater satisfaction

1 Brod M e t al. Qual Life Res. 2006 Apr;15(3):481-91.

7

Objectives


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

Pre-study therapy

19%

81%

OAD Only

Insulin +/ - OAD Insulin ± OADs OAD alone Total

Canada 829 626 1455

China 1766 12 886 14 652

India 4026 11 510 15 536

Japan 24 1721 1745

Poland 0 3656 3656

Russia 959 1012 1971

Total 7604 31 411 39 015


9

Insulin +/- OAD OAD alone

Number enrolled 7604 31.411

Mean age ± SD (years) 57.1 ± 12.0 56.2 ± 11.6

Gender, M/F (%) 55/45 57/43

Mean weight ± SD (kg) 72.54 ± 16.80 70.84 ± 14.55

Mean BMI ± SD (kg/m2) 26.97 ± 5.46 26.08 ± 4.63

Mean diabetes duration ± SD (years) 10.16 ± 7.38 7.34 ± 5.36

Mean HbA1c ± SD (%) 9.29 ± 1.87 9.23 ± 1.77

Results - Overview of baseline characteristics by pre-study therapy


10

56,8

63,6 64,2

43,0

73,8 75,5 75,071,0

0

10

20

30

40

50

60

70

80

90

100

Overall score(N=16,550)

Burden(N=15,959)

Symptoms(N=16,246)

Efficacy(N=16,205)

Tre

atm

ent

sati

sfact

ion

Baseline

Final

17.0***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


11

56,559,4

63,4 64,6 63,9 66,2

42,447,6

73,8 73,9 75,3 76,3 75,1 74,671,0 70,8

0

10

20

30

40

50

60

70

80

90

100

OAD only(N=14,720)

Insulin +/-OAD

(N=1858)

OAD only Insulin +/-OAD



Tre

atm

en

t sa

tisf

act

ion

Baseline Final

17.0*** 14.5***

NS=Not Significant

*) p<0.05

**) p<0.01

***) p<0.001

Results - QoL by pre-study therapy


11.9*** 11.7*** 11.2*** 8.4*** 28.6*** 23.2***

Overall scoreBurden Symptoms Efficacy

12

0%

24%

37%

16%

12%

8%

1%0% 1%3%

8%

29%

53%

6%

0%

10%

20%

30%

40%

50%

60%

Extremelydissatisfied

Verydissatisfied

Slightlydissatisfied

Neitherdissatisfiedor satisfied

Slightlysatisfied

Verysatisfied

Extremelysatisfied

Baseline (N=17208)

Final (N=14943)

Results - Distribution of Q7. Total cohort


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


• 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

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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