Title: Quality of life improves after patients switch to biphasic insulin aspart 30/70 (BIAsp 30): IMPROVE
1Quality 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
2Agenda
- IMPROVE study design
- Objectives for this analysis
- Methods
- Diabetes Medication Satisfaction Questionnaire
- Patients
- Results
- Conclusion
MGSD 2009 - IMPROVE global data cut March 2008
3Study 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
4Significant reduction of HbA1c
HbA1c
Mean HbA1c
Data on file
5No significant change of minor hypoglycaemia
HbA1c
events/patient year
Data on file
6Methods
- 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.
MGSD 2009 - IMPROVE global data cut March 2008
7Objectives
- 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
MGSD 2009 - IMPROVE global data cut March 2008
8Methods - 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
MGSD 2009 - IMPROVE global data cut March 2008
9Results - 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
MGSD 2009 - IMPROVE global data cut March 2008
10Results - 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
MGSD 2009 - IMPROVE global data cut March 2008
11Results - 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
MGSD 2009 - IMPROVE global data cut March 2008
12Results - 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)?
MGSD 2009 - IMPROVE global data cut March 2008
13Conclusions
- 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