Transcript Premix Insulin

NN-Iran/MIP/001/Jan 2010/1
Position of
“Premix Insulin” in
the Management of
Type 2 diabetes
Dr. Khalilzadeh /Endocrinologist
Novo Nordisk A/S
06 April 2016
World Health Organization’s
(WHO) definition of diabetes
A metabolic disorder of multiple
aetiology characterized by chronic
hyperglycaemia with disturbances
of carbohydrate, fat and protein
metabolism resulting from defects
in insulin secretion, insulin
action, or both
Slide no 2
Novo Nordisk A/S
06 April 2016
Classification of Diabetes
Type 1
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10% of diabetes
Younger usually <20 years
Normal body weight
Normal blood pressure
Absolute insulin deficiency
May or may not have lipid anomalies
Type 2
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•
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90 to 95% of diabetes
Older usually > 30 years
Relative insulin deficiency
Insulin resistance syndrome, obesity
High BP
Dyslipedemia
 HDL,
 TG
 LDL (increased small, dense
particles)
Slide no 3
Novo Nordisk A/S
06 April 2016
Date
Diabetes (today – tomorrow)
Rapid growth in diabetes prevalence
284.6 million
438.4 million
2010
2030
Slide no 4
Date
Diabetes Prevalence was underestimated…
The number of people with
diabetes in 2011 has reached a
staggering 366 million
IDF Fact Sheet updated in EASD 2011
Slide no 5
The Clock is ticking for the world’s leaders
4.6 million deaths due to
diabetes in 2011!
One person is dying from
diabetes every seven seconds!
IDF 2011 Fact Sheet
Novo Nordisk A/S
06 April 2016
*Esteghamati A, et al. Third national surveillance of risk factors of non-communicable diseases (SuRFNCD-2007) in Iran: methods and results on
prevalence of diabetes, hypertension, obesity, central obesity, and Dyslipidemia. BMC Public Health 2009, 9:167
T2D Diabetes population in Iran
Rule of halves
208,000
3,237,559 (age 25-64)
3,237,559
1,717,889 (apprx. 53%)
860,000
430,000
208,000
Slide no 7
Data collection overview
IRAN A1chieve
•
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Week 0
~Week 12
Baseline visit
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Iran
• 84 investigators
• 919 subjects
GLOBAL
3166 investigators
66726 subjects
~Week 24
Final visit
Interim visit
Informed consent
Eligibility
Demographics
Medical history
Diabetes treatment
history
• Quality of life – EQ5D
• Weight
• Weight
• Current diabetes
treatment regimen
• Current diabetes
treatment regimen
• Blood glucose control
parameters
• Blood glucose control
parameters
• Hypoglycaemia
• Hypoglycaemia
• AE and ADR
• AE and ADR
• Quality of life - EQ5D
AE, adverse event; ADR, adverse drug reaction
HbA1c - by pre-study therapy
IRAN A1chieve
Global
n=
57250 717
4922 22
33717 453
Iran
18611 242
Diabetes-related complication
prevalence : IRAN A1chieve
Global
n=65513
Iran
n=919
Cardiovascular (%)
27.2
27.7
Neuropathy (%)
38.4
57.7
Renal (%)
27.9
27.9
Eye (%)
26.3
38.0
5.4
7.9
Complications
Foot ulcer (%)
A patient can have multiple complications
Novo Nordisk A/S
06 April 2016
For Optimal Management We
Should Target……
HbA1C
The long-term average glucose level
PPG
The peak
glucose level
FPG
The basal
glucose level
Slide no 11
Novo Nordisk A/S
06 April 2016
Slide no 12
1% drop in HbA1C
Correlation between a 1% HbA1C decrease and reduced risk of
complications (T2DM)
43%
37%
19%
Cataract
extraction
16%
Heart failure
14%
Myocardial
infarction
12%
Stroke
Microvascular
disease
Lower extremity
amputation or
fatal peripheral
vascular disease
Cardiovascular complications
UKPDS-Stratton IM et al. BMJ 2000;321:405-412.
Management of Type 2
Diabetes
13
NN-Iran/MIP/001/Jan 2010/1
The different diabetes management guidelines
all target HbA1c of < 7%
APPG (Asia Pacific)7
HbA1c < 6.5%
(Canada)4
CDA
HbA1c  7%
NICE (UK)5
HbA1c 6.5–7.5%
ADA (US)1
HbA1c < 7%
AACE (US)2
HbA1c  6.5%
1American
ALAD (Latin America)6
Australia8
HbA1c  7%
IDF (Europe)3
HbA1c  6.5%
HbA1c < 6–7%
Diabetes Association. Diabetes Care 2009; 32 (Suppl. 1):S13–S61. 2American Association of Clinical Endocrinologists. Endocr Pract 2009; 15 (6):540-559.
3European Diabetes Policy Group. Diabet Med 1999; 16:716–730. 4Canadian Diabetes Association. Can J Diabetes 2008; 32 (Suppl. 2):S1–S201.
5National Institute for Clinical Excellence. 2002. Available at: http://www.nice.org.uk. 6ALAD. Rev Asoc Lat Diab 2000; Suppl. 1.
7Asian-Pacific Policy Group. Practical Targets and Treatments (3rd Edition). 8NSW Health Department. 1996.
ADA – EASD
Guideline 2012
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Management of Hyperglycemia in
Type 2 Diabetes:
A Patient-Centered Approach
Position Statement of the American Diabetes Association
(ADA) and the European Association for the Study of
Diabetes (EASD)
April 19, 2012
More Stringent HbA1c Targets (6.0 – 6.5%)
• Short disease duration
• Long life expectancy
• No significant CVD
If this can be achieved without significant
hypoglycemia or other adverse effects of
treatment
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Less Stringent HbA1c Targets (7.5 – 8.0%
or even slightly higher)
• History of severe hypoglycemia
• Limited life expectancy
• Advanced complications
• Extensive comorbid conditions
In whom the target is difficult to attain despite
intensive self-management education, repeated
counseling, and effective doses of multiple
glucose-lowering agents, including insulin
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Lifestyle Interventions:
At diagnosis, highly motivated patients with
HbA1c already near target (<7.5%) could be
given the opportunity to engage in lifestyle
change for a period of 3–6 months before
embarking
on
pharmacotherapy
(usually
metformin)
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Transitions to and titrations of
Insulin:
• Perhaps more convenient but less adaptable
method involves “premixed” insulin
• Traditionally, administered twice daily, before
morning and evening meals
• In comparison with basal insulin alone, premixed
regimens tend to lower HbA1c to a larger degree,
but often at the expense of slightly more
hypoglycemia and weight gain
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Transitions To and Titrations of
Insulin:
“premixed” insulin approach
•This strategy may be appropriate for certain
patients who eat regularly and may be in need of a
simplified approach beyond basal insulin
•Disadvantages: inability to titrate the shorterfrom the longer-acting component
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Key Message
Again, individualization of therapy is key,
incorporating the degree of hyperglycemia
needing to be addressed and the overall
capacities of the patient.
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2011 IDF Guideline
NovoMix® 30 - Abbreviated prescribing
information
Abbreviated Prescribing Information
NovoMix® 30 (biphasic insulin aspart).
Refer to the Summary of Product Characteristics (SPC) before prescribing.
Presentations: NovoMix® 30 FlexPen®. All presentations contain soluble insulin aspart/ protamine-crystallised insulin aspart 100 units/ml in the ratio
of 30/70. Indication: Treatment of diabetes mellitus. Dosage: Individual by subcutaneous injection. NovoMix® 30 has a faster onset of action than
biphasic human insulin and should generally be given immediately before a meal. When necessary, NovoMix ® 30 can be given soon after start of a
meal. In patients with type 2 diabetes, NovoMix® 30 can be given in monotherapy or in combination with metformin when the blood glucose is
inadequately controlled with metformin alone. Contraindications: Hypoglycaemia, hypersensitivity to insulin aspart or to any other of the
ingredients. Warnings and precautions: Inadequate dosages or discontinuation of treatment may lead to hyperglycaemia and ketoacidosis, which
are potentially lethal. A change in the usual early warning symptoms of hypoglycaemia may be seen upon tightening control. The fast onset of action
should be considered in patients where a delayed absorption of food might be expected. Transferring to a new type or brand of insulin should be done
under strict medical supervision. Too much insulin, omission of a meal or strenuous exercise may lead to hypoglycaemia. Compared with biphasic
human insulin, NovoMix® 30 may have a stronger hypoglycaemic effect up to 6 hours after injection. This may need to be compensated for through
adjustment of dose and/or food intake. Hypoglycaemia may constitute a risk when driving or operating machinery. Elderly patients: NovoMix® 30
can be used in elderly patients; however there is limited experience with the use of NovoMix ® 30 in combination with OADs in patients older than 75
years. Pregnancy and lactation: Limited clinical experience in pregnancy. No restrictions on use during lactation. Side effects: Most of the
following undesirable effects are uncommon, rare or very rare. Hypoglycaemia. Oedema, refraction anomalies and local hypersensitivity can occur on
instituting therapy and are usually transitory in nature. Acute painful peripheral neuropathy may occur upon fast improvement in blood glucose
control but is usually reversible. Generalised hypersensitivity reactions are rare but potentially life-threatening. Lipodystrophy, worsening of diabetic
retinopathy. Major drug interactions: Oral Hypoglycemic Agents (OHAs), Monoamine Oxidase Inhibitors (MAOIs) and non-selective beta-adrenergic
blocking agents may reduce the patient’s insulin requirements. Oral contraceptives and thyroid hormones may increase the patient’s insulin
requirements. Please refer to the patient information leaflet for more information. Prescription only medicine Full prescribing information can
be obtained free of charge from Novo Nordisk. IRC number: 1228066993
Novo Nordisk Pars
11th flr. Kian Tower, No.1387
Naseri St. Vali e Asr Ave.Tehran
Tel: 88645221-28
NN-Iran/MIP/001/Jan 2010/1
Novo Nordisk Pars
11th floor, Kian Tower
No. 1387, Vali-e-Asr Ave.
Tehran
Iran