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Position of Position of “Premix Insulin” in “Premix Insulin” in the Management of the Management of

Type 2 diabetesType 2 diabetes

Dr. Khalilzadeh /EndocrinologistDr. Khalilzadeh /Endocrinologist

Novo Nordisk A/S Slide no 221 April 2023

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

Novo Nordisk A/S Slide no 321 April 2023

Classification of Diabetes Type 1 Type 2

• 10% of diabetes • Younger usually <20 years• Normal body weight• Normal blood pressure• Absolute insulin deficiency• May or may not have lipid anomalies

• 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)

Novo Nordisk A/S Slide no 421 April 2023 Slide no 4Date

Diabetes (today – tomorrow)Rapid growth in diabetes prevalence

284.6 million 438.4 million

54% in

crease

in

20 years

2010

2030

Slide no 5Date

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

The Clock is ticking for the world’s leaders

One person is dying from diabetes every seven seconds!

IDF 2011 Fact Sheet

4.6 million deaths due to

diabetes in 2011!

Novo Nordisk A/S Slide no 721 April 2023

Rule of halves

T2D Diabetes population in Iran

3,237,559 (age 25-64)

1,717,889 (apprx. 53%)

860,000

430,000

208,000

3,237,559

208,000

*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

Final visit

GLOBAL

Data collection overviewIRAN A1chieve

Interim visitBaseline visit

Week 0 ~Week 24~Week 12

• Weight

• Current diabetes treatment regimen

• Blood glucose control parameters

• Hypoglycaemia

• AE and ADR

• Quality of life - EQ5D

• Weight

• Current diabetes treatment regimen

• Blood glucose control parameters

• Hypoglycaemia

• AE and ADR

• Informed consent• Eligibility• Demographics• Medical history• Diabetes treatment

history• Quality of life – EQ5D

• 3166 investigators• 66726 subjects

Iran• 84 investigators• 919 subjects

AE, adverse event; ADR, adverse drug reaction

HbA1c - by pre-study therapyIRAN A1chieve

57250 4922 33717 18611n=

Global Iran

717 22 453 242

Diabetes-related complication prevalence : IRAN A1chieve

ComplicationsGlobal

n=65513Iran

n=919

Cardiovascular (%) 27.2 27.7

Neuropathy (%) 38.4 57.7

Renal (%) 27.9 27.9

Eye (%) 26.3 38.0

Foot ulcer (%) 5.4 7.9

A patient can have multiple complications

Novo Nordisk A/S Slide no 1121 April 2023

FPG The basal glucose level

PPGThe peak

glucose level

HbA1CThe long-term average glucose level

For Optimal Management We Should Target……

Novo Nordisk A/S Slide no 1221 April 2023

UKPDS-Stratton IM et al. BMJ 2000;321:405-412.

Correlation between a 1% HbA1C decrease and reduced risk of complications (T2DM)

43% 37% 19% 14%

Lower extremity amputation or fatal peripheral

vascular disease

Microvascular disease

Cataract extraction

Myocardial infarction

16%

Heart failure

12%

Stroke

Cardiovascular complications

1% drop in HbA1C

Management of Type 2

Diabetes

13

The different diabetes management guidelines The different diabetes management guidelines all target all target HbAHbA11cc of < 7%of < 7%

ADA (US)1

HbA1c < 7% IDF (Europe)3

HbA1c 6.5%

CDA (Canada)4

HbA1c 7%

NICE (UK)5

HbA1c 6.5–7.5%

AACE (US)2

HbA1c 6.5% ALAD (Latin America)6

HbA1c < 6–7%

APPG (Asia Pacific)7

HbA1c < 6.5%

Australia8

HbA1c 7%

1American 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.

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ADA – EASD Guideline 2012

15

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

23

• 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

24

Less Stringent HbA1c Targets (7.5 – 8.0% or even slightly higher)

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)

26

• 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

32

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 shorter- from the longer-acting component

33

Transitions To and Titrations of Insulin:

Key Message

Again, individualization of therapy is key,

incorporating the degree of hyperglycemia

needing to be addressed and the overall

capacities of the patient.

34

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

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

Novo Nordisk ParsNovo Nordisk Pars1111thth floor, Kian Tower floor, Kian TowerNo. 1387, Vali-e-Asr Ave.No. 1387, Vali-e-Asr Ave.TehranTehranIranIran

NN-Iran/MIP/001/Jan 2010/1