Professional Documents
Culture Documents
RTD LEVEMIR®
Outlines
• Prevalence
• Rationale for early initiation
• T2DM management and guideline
• Insulin Levemir® & A1Chieve study
Sources :
1. IDF Diabetes Atlas, 8th ed
Number of people with diabetes worldwide and per region in 2017 and 2045
(20-79 years)
Diabetes:
A Global Emergency
Sources :
1. IDF Diabetes Atlas, 8th ed
Prevalence of Obesity and Diabetes in Indonesia: Health Basic Research,
2013
Insulin resistance
Insulin secretion
PPG
FPG
Microvascular complications
Macrovascular complications
1. Adapted from: Ramlo-Halsted BA, Edelman SV. Clincial Diabetes 2000;18(2): http://journal.diabetes.org/clinicaldiabetes/v18n22000/pg80.htm
Hyperglycemia affects both micro-vascular and macro-vascular complications
Macro-vascular
Micro-vascular
80%
70% 68%
60%
50%
40%
30%
20% 15%
10% 8%
10% 6% 4% 4%
0%
Soewondo, P, et al. The DiabCare Asia 2008 Study – Outcomes on control and complications of type 2 Diabetets
patients in Indonesia. Med J Indones 2010; 19:235-44)
Risk of complications increases as HbA 1c increases
1000 patient-years
Microvascular disease
Incidence per
Myocardial infarction
Outlines
• Prevalence
• Rationale for early initiation
• T2DM management and guideline
• Insulin Levemir® & A1Chieve study
Poor glycemic control (HbA1c) is a global problem
Patients
achieving
targets (%)
60 <7% <7%
50
53
40 51 <7%
<6.5%
30
36
20 31
10
0
USA Canada EUROPE Emerging countries*
(NHANES)1 (DICE)2 (CODE-2)3 (IDPMS)4
*Asia, Eastern Europe, Latin America and the Middle East and Africa
• In the real world, only 50% of patients do not achieve their glycemic goals1
1. Casagrande S, et al. Diabetes Care 2013;36:2271-9; 2. Harris SB, et al. Diabetes Res Clin Pract 2005;70:90-7;
3. Liebl A, et al. Diabetologia 2002;45:S23-8; 4. Chan JC, et al. Diabetes Care 2009;32:227-33.
Patients remain on multiple OAD therapy too long
8.9%
control
• Guidelines encouraging earlier use
of insulin
10.0 +0.2%
0.5%*
−1.0%*
9.0 Pre-treatment
Mean HbA1c (%)
Post-treatment
8.0
7.0
6.0
2 OADs 3 OADs 4 OADs Insulin
*p<0.001
OADs, oral antidiabetic drugs
Calvert et al. Br J Gen Pract 2007;57:455–60
Insulin remains the most efficacious glucose lowering agent
CSII, continuous subcutaneous insulin infusion; MDI, multiple daily injection; OHA, oral hypoglycaemic agent
Weng et al. Lancet 2008;371:1753–60
ESW/MAR-17/RTD LVM-2017/001
Outlines
• Prevalence
• Rationale for early initiation
• T2DM management and guideline
• Insulin Levemir® & A1Chieve study
How to individualize
Insulin Treatment
In Type 2 DM
American Diabetes Association. Diabetes Care Volume 41, Supplement 1, January 2018
Anti-hyperglycemic therapy in adults with type 2 diabetes
A1C is greater than or equal 10%, blood glucose is greater than or equal 300 mg/dL, or
patient markedly symptomatic, consider combination injectable therapy.
Dual Therapy
American Diabetes Association. Diabetes Care Volume 41, Supplement 1, January 2018
Anti-hyperglycemic therapy in adults with type 2 diabetes
A1C is less than 9%, consider monotherapy.
Monotherapy
Triple Therapy
American Diabetes Association. Diabetes Care Volume 41, Supplement 1, January 2018
Anti-hyperglycemic therapy in adults with type 2 diabetes
A1C is less than 9%, consider monotherapy.
A1C is greater than or equal 10%, blood glucose is greater than or equal 300 mg/dL
or patient markedly symptomatic, consider combination injectable therapy.
Monotherapy
Dual Therapy
Triple Therapy Lifestyle Management + Metformin + 2 additional agent
American Diabetes Association. Diabetes Care Volume 41, Supplement 1, January 2018
Combination Injectable therapy for type 2 Diabetes
American Diabetes Association. Diabetes Care Volume 41, Supplement 1, January 2018
Fasting plasma glucose is having high contribution in HbA1c > 8,5%
overall hyperglycaemia
Relative contribution to
100
80 30%
45% 35%
50%
60 70%
(%)
40 70%
65%
50% 55%
20
30%
0
<7.3 7.3–8.4 8.5–9.2 9.3–10.2 >10.2
HbA1c quintiles
FPG PPG
Start: 4 units, or 0.1kg, or 10% basal dose. If A1C Start: Add additional injection before lunch
<8%, consider lower basal by same amount If goals not met, consider
changing to injectable Adjust: increase dose by 1-2 units or 10-15% once
Adjust: increase dose by 1-2 units or 10-15% once or therapy or twice weekly until SMBG target reached
twice weekly until SMBG target reached
For hypo: Determine & address cause; if no clear
For hypo: Determine & address cause; if no clear Reason for hypo, reduce dose by 2-4 units or 10-20%
Reason for hypo, reduce dose by 2-4 units or 10-20%
American Diabetes Association. Diabetes Care Volume 41, Supplement 1, January 2018
ESW/MAR-17/RTD LVM-2017/001
Outlines
• Prevalence
• Rationale for early initiation
• T2DM management and guideline
• Insulin Levemir® & A1Chieve study
Efficacy of Basal Insulin Focus on Detemir
29
Levemir®
2012–2014 tolerability profile
2010–2011 demonstrated over
•SOLVE™
2007–2009
A1chieve™ >17.000 patients7 10 years
TITRATE™ >66,000
2004–2006 of clinical
>224 patients3 patients5 •DIET™8
experience and
Klein et al1 evidence 1–8
PREDICTIVE™ TRANSITION™
6
1. Klein O et al. Diab Obes Metab 2007; 9:290-299, 2. Phillis-Tsimikas. Clin Ther 2006;28(10):1569–81, 3. Blonde L et al. Diabetes Obes
Metab. 2009; 11(6):623-631, 4. Hollander et al. Diab Obes Metab 2011; 13:268-275, 5. Home et al. Diabetes Res Clin Pract 2011;94:352–63,
6. Khunti et al. Diabetes Obes Metab. 2012, 7. Hollander PA, Diabetologia 2012; 55 (Suppl. 1): Abstract 939-P
ESW/MAR-17/RTD LVM-2017/001
30
Adapted from Heise T et al. Diabetes. 2004;53:1614-20.
Home et al. Diabetes Res Clin Pract 2011;94:352–63
A1chieve overview
Insulin Detemir use in Indonesia
Start
Start aa study
study BASELINE
BASELINE INTERIM
INTERIM FINAL
FINAL
insulin
insulin Week
Week 00 Week
Week 12
12 Week
Week 24
24
•• Biphasic
Biphasic insulin
insulin
aspart
aspart 30
30
•• Insulin
Insulin detemir
detemir • Study objectives
•• Insulin
Insulin aspart
aspart • Primary: number of attributed adverse drug
reactions (includes major hypoglycaemia)
• Secondary: other safety and effectiveness
measures
Detemir ± OAD:
*p<0.001
Soewondo et al. DRCP 2013. 100;(Suppl 1):S10-S16
Detemir ± OAD:
Indonesia hypoglycaemia results
Baseline
24 weeks
Overall Major Nocturnal
No. of pt w/hypo 19 0 1 0 18 0
Percent with at least one
event
Significant
Significant improvement
improvement
(p<0.001)
(p<0.001)
*p<0.001
Soewondo et al. DRCP 2013. 100;(Suppl 1):S10-S16
Initiation & titration of basal Insulin
Goal: 3.9–5.0 mmol/L Goal: 4.4–6.1 mmol/L
(70–90 mg/dL)1 (80–110 mg/dL)1
If FPG is If FPG is
+3
units
>5.0 mmol/L (>90 mg/dL) >6.1 mmol/L (>110 mg/dL)
–3
<3.9 mmol/L (<70 mg/dL) units <4.4 mmol/L (<80 mg/dL)
Summary
Indonesia is one of the largest diabetes population
Insulin therapy is the most efficacious therapy and can reduce HbA1c up to
2,5%
Starting with basal insulin detemir 10 U once daily and titrate based on
patient condition to reach glycemic control