Quality of life improves after patients switch to biphasic insulin aspart 30/70 (BIAsp 30): IMPROVE

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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. 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
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Agenda

• IMPROVE study design
• Objectives for this analysis
• Methods
• Diabetes Medication Satisfaction Questionnaire
• Patients
• Results
• Conclusion

MGSD 2009 - IMPROVE global data cut March 2008
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Study design- Design overview
Primary endpoints
Secondary endpoints
Study design

• 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

• 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 (NovoMix30) therapy
MGSD 2009 - IMPROVE global data cut March 2008
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Significant reduction of HbA1c
HbA1c
Mean HbA1c
Data on file
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No significant change of minor hypoglycaemia
HbA1c
events/patient year
Data on file
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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
Apr15(3)481-91.
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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

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Methods - Patients by pre-study therapy and
country
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
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Results - Overview of baseline characteristics
by pre-study therapy
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
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Results - QoL for total cohort of all pre-study
treated
11.9
10.9
17.0
28.0
NSNot Significant ) plt0.05 ) plt0.01 )
plt0.001
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Results - QoL by pre-study therapy
17.0 14.5
11.9 11.7
11.2 8.4
28.6 23.2
NSNot Significant ) plt0.05 ) plt0.01 )
plt0.001
Symptoms
Burden
Efficacy
Overall score
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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)?
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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

MGSD 2009 - IMPROVE global data cut March 2008