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Insulin Initiation :Benefit ofInsulin Detemir in type 2 DMManagement
Sony Wibisono M
Surabaya Diabetes andNutrition Center Dr. Soetomo
Teaching Hospital, Facultyof MedicineAirlanggaUniversity,
Surabaya
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OutlinesPresentation structure
Diabetes is a progressive disease and is increasingin prevalence
The mapping of insulin treatment based recent guidelines
Insulin Initiation, when we should start with basal insulin
Insulin therapy in or outpatient in clinical practice
Conclusion
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20102000171 million1
2030
552 million2
2011
366 million2
Diabetes is a global diseaseEstimated global prevalence of diabetes
1. Wild. Diabetes Care. 2004. 27:1047-1053.2. International Diabetes Federation. IDF Diabetes Atlas. Fifth Edition. 2011
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1. Adapted from: Ramlo-Halsted BA, Edelman SV. Clincial Diabetes 2000;18(2): http://journal.diabetes.org/clinicaldiabetes/v18n22000/pg80.htm
T2DM: Progressive loss of insulin
secretion with increasing insulin resistance
1
Impairedglucose tolerance
Undiagnoseddiabetes
Insulin resistance
Knowndiabetes
Insulin secretionPostprandial glucose
Fasting glucose
Microvascular complications
Microvascular complications
Macrovascular complications
Macrovascular complications
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Diabetes is a progressive disease
Type 2 diabetes (T2DM) progression is characterised by decline in beta-cell function andworsening insulin resistance1
Getting to, or maintaining, target HbA1c levels in T2DM requires intensified treatmentover time2
1. Fonseca VA. Br J Diab Vasc Dis 2008;8:S32. Nathan DM, et al. Diabetes Care 2009;32:193-203
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Diabetes being a progressive disease that is increasing
in prevalence
T2DM results in a progressive loss of insulin secretion with increasing insulinresistance1
By 2030, IDF predicts 552 million people worldwide will have diabetes2
Diabetes is the fourth most common diagnosed chronic condition3
Many people with diabetes do not have good glycaemic control3
1. Ramlo-Halsted BA, Edelman SV. Clincial Diabetes 2000;18(2): http://journal.diabetes.org/clinicaldiabetes/v18n22000/pg80.htm2. International Diabetes Federation. IDF Diabetes Atlas. Fifth Edition. 20113. Brunton. Curr Med Res Opin 2011;2765-72
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New position statement of the ADA and EASD onmanagement of hyperglycemia in type 2 diabetes
I n z u c c i SE , e t a l . D ia b e t o l o g i a . 2 0 1 2
BasalInsulin
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New ADA/EASD Position on Sequential InsulinStrategy in Type 2 Diabetes
Non-InsulinRegimes
Basal Insulin OnlyUsually with OAD
Basal Insulin + 1 mealtimerapid-acting injection Pre-mixed Insulin twice-daily
Basal Insulin + 2 mealtimerapid-acting injection
1
2
+3
Low
Mod.
High
Number ofInjections
RegimenComplexity
FlexibilityLess FlexibleMore Flexible
Convenience*More ConvenientLess Convenient
Inzucci SE, et al. Diabetologia. 2012. * Gumprecht et al. Intensification to to biphasic insulinaspart 30/70. Int J Clin Pract 2009
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Patient Centered Approach
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What is the optimal target HbA1c level?
Goals of optimum HbA1c levels:
Good glycaemic control
Minimise development and progression of microvascularand macrovascular complications
HbA1c
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Treat T2DM early for long-term benefits1
Long-term benefits in reducing cardiovascular risk can be achieved withgood control from diagnosis1
-14%
-37%
-21%
Myocardial infarction
Microvascular complications
Death related to diabetes
Each HbA1cpercentage
pointreductioncounts3
HbA1c
-1%
1. Holman, et al. NEJM2008;359:1577892. UKPDS 6. Diabetes Res 1990;13(1):1-113. Stratton, et al. BMJ2000;321(7258):405-12
50% of patients with T2DM with complicationsalready have them at diagnosis2
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Insulin remains the most efficacious glucoselowering agent
Decrease in HbA1c: Potency of monotherapy
HbA1c
%
Nathan et al., Diabetes Care 2009;32:193-203.
CHOOSING INSULIN EARLIERFOR BETTER EFFICACY
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Insulin can be initiated at any time
Traditionally, insulin has been reserved as the last line of therapy
However, considering the benefits of normal glycemic status, Insulin
can be initiated earlier and as soon as possible
InadequateLifestyle
+ 1 OAD + 2 OAD + 3 OAD
INITIATE INSULIN
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How to start Basal Insulin Start with basal insulin (Insulin Detemir) 10 U or 0,1-0,2 U per Kg BB
Once daily injection, anytime injection but in same time per each day
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Simple Dose titration with Levemir
Patients who experienced hypoglycemia reduced their daily dose by 3 units
FPG target range70-90 mg/dL
FPG 90 mg/dl (5.0 mm/L)
Mean 3-day FPG (mg/dL)
Maintaindose
units
FPG target range80-110 mg/dL
FPG 110 mg/dL (6.1 mmol/L)
Blonde L et al. D ia b et e s O b es M e t ab . 2009; 11(6):623-631.
Increase
3 units
Decrease
3 units
Levemir Dose Titration Guidelines:3-0-3 Algorithm
Start with Levemir 10 U or 0,1-0,2 U per Kg BB
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Levemir/Glargine Head-to-Head:Similar Profiles in Type 2 Diabetes
Time (h)
Klein O et al. Diab Obes Metab 2007; 9:290-299
Glucoseinfus
ionrate
(mg/kg/m
in)
0 2 4 6 8 10 12 14 16 18 20 22 24
0
0.5
1.0
1.5
2.0
2.5
3.0
0.4 U/kg 0.8 U/kgInsulin detemir
Insulin glargine
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Levemir reduces nocturnal hypoglycaemia by up to65% compared to NPH
Phillis-Tsimikas. Clin Ther 2006;28(10):156981; Riddle et al 2003. Diabetes Care; 26 (11): 3080-6; Asakura T et al, 2008. Expert Opin Pharmacother; 10 (9): 1-5; Hanel H et al 2008. J Diabetes
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Insulin NPH
Insulin Determir
Insulin glargine
Relative
Risk
Riddle et al., 2003 Phillis-Tsimikas et al., 2006
-29% -44% -53% -65%
NPH vs. glargine NPH vs. detemir
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Observational study of people with T2DM inroutine clinical practice
Study objectives
Primary: number of attributed adverse drugreactions (includes major hypoglycaemia)
Secondary: other safety and effectivenessmeasures
BASELINEWeek 0BASELINEWeek 0
INTERIMWeek 12INTERIMWeek 12
FINALWeek 24FINALWeek 24
Start a studyinsulin
Biphasic insulinaspart 30
Insulin detemir Insulin aspart
Start a studyinsulin
Biphasic insulinaspart 30
Insulin detemir Insulin aspart
A1chieve study overview and design
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HbA1c (%) FPG (mg/dl) PPG (mg/dl)
Baseline values 9.5 219 263
n 147 317 295
Levemir OAD:Indonesia efficacy results
-101*
-115*
-120
-100
-80
-2.2*
-3.0
-2.0
-1.0
0.0
Changefrom
baselineto
week24
Insulin nave
*p
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Levemir OAD:Indonesia hypoglycaemia results
5,10
0,30
4,80
0,00 0,00 0,000,0
1,0
2,0
3,0
4,0
5,0
6,0
Overall Major Nocturnal
Insulin nave Insulin nave Insulin nave
No. of pt w/hypo 19 0 1 0 18 0
Perc
entwithatleastoneeven
t
Baseline24 weeks
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A1chieve: Self-rated health in insulin naive
patients (Levemir)
24 weeks
Baseline
Best imaginablehealth
Worst imaginablehealth
Patients onLevemir
0
10
20
30
40
50
6070
80
90
100
Baseline 24 weeks
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Levemir
NovoRapid
Insulin endogen
--------
NovoMix
Breakfast Lunch Dinner Bed time
Physiologic insulin secretionAnalogue insulin mechanisme of action
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2 00 - 3003 00 - 4004 00 - 5005 00 - 6006 00 - 700
468
1012
EXAMPLE :HYPERGLYCEMIA 680 mg/dl
APIDRA
DOSE (S.C.): FORMULA X2.MT6 X2 = 12 UNITS
APIDRA for TOMMOROW : 3 X 12 U
HYPERGLYCAEMIA >200 mg/dl, EXAMPLE : 680 mg/dlFORMULA X2. MT FOR SGC AND MAINTENANCE S.C. DOSEFORMULA X2. MT
BASELINE GLUCOSEBefore SGC (mg/dl)
NOVORAPID DOSESubcutaneous (S.C.) Injection in unit
SUBCUTANEOUS GLYCEMIC CONTROL (SGC)(Clinical Experiencies : Tjokroprawiro 1987-2013)
6 X2 = 12FORMULA X2. MT
680
APIDRA : Onset 5-15 Mins; Peak 1-2 Hrs; Duration 3-4 Hrs
MT = MAINTENANCE
RGC
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Continued
or
- LEVEMIR : 20 units (1/3 of 60) Mornings
- SU : Mornings, or Mornings and EveningsAMETHOD- - NOVORAPID : Formula X2
-LEVEMIR : 20 units Evenings
- SU : Mornings, or Mornings and EveningsBMETHOD- - NOVORAPID : Formula X2
PERKENI-CONSENSUS 2006 : Insulin Dose > 30 Units/day in CTOIis not Recommended STOP OAD, and Give PREMIX Twice Daily (ADA/EASD-2012)
INPATIENTS TREATED withAPIDRA 3x 20Units per Day:1Total dose of NOVORAPID 60 units perDay
USE FORMULA 1/3METHOD- A OR B
(Clinical Experiences : Tjokroprawiro 2007-2013)(Clinical Experiences : Tjokroprawiro 2007-2013)
CTOI with FORMULA 1/3 for DISCHARGED-PATIENTS
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or
2 DIABETIC OUTPATIENTS FAILED with 2-4 OADs :
the figures of the first two fe. : 1-h PG450 mg/dL, theFirst two is45depending on 1-h PG (OneHour PlasmaGlucose) , and Special attention to
FORMULA 1/3 (based onthe figures of the first two , that is 45):Thus, the Initial Dose : 1/3 of 45 = 15 Units
(Clinical Experiences : Tjokroprawiro 2007-2013)(Clinical Experiences : Tjokroprawiro 2007-2013)
CTOI with FORMULA 1/3 for DIABETIC-OUTPATIENTS16
- LEVEMIR : 15 Units Mornings (At the Same Time of the Day)
- SU : Mornings, or Mornings and EveningsAMETHOD- - NOVORAPID : Formula X2
- LAVEMIR : 15 units Evenings (At the Same Time of the Day)
- SU : Mornings, or Mornings and EveningsBMETHOD- - NOVORAPID : Formula X2
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3 Units Increase if Pre Prandial PG(Morning-Glucose) : 130-200 mg/dL
5 Units Increase if Pre Prandial PG(Morning-Glucose) : > 200 mg/dL
II STEP-DOWN FORMULAS TO END LEVEMIR INJECTIONTHE 1st FIGURE ( 2or1 ) INDICATES DAY, whereas :
THE 2nd FIGURE ( 2or1 ) INDICATES DECREASE in LEVEMIR DOSE
FORMULA 2-2 : Every 2Days 2 U Decrease , until LEVEMIR INJECTIONOFF
Every2Days 1 U Decrease ,FORMULA 2-1 : until LEVEMIROFFFORMULA 1-2 : EveryDay 2 U Decrease , until LANTUSOFF
FORMULA 1-1 : EveryDay 1 U Decrease , until LANTUSOFF
(Clinical Experiences : Tjokroprawiro 2003-2013)(Clinical Experiences : Tjokroprawiro 2003-2013)
FORMULAS : 1/3 , STEP-UP : 3-3-5 , STEP-DOWN : 2-2 , 2-1 , 1-2 , 1-1
ISTEP-UP FORMULA 3-3-5 WITH LEVEMIR
THE 1st 3 INDICATES DAY, whereas the 2nd & 3rd 3& 5 INDICATE LEVEMIR DOSE
INCREASING INSULIN DOSE (3 or 5 units) after 3 DAY-EVALUATION
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FORMULA MP-25.4
FORMULA DEX-4.4
(Clinical Experiences: Tjokroprawiro 2010-2013)
APIDRA FORMULA for STEROID TREATED DM-Pts
FORMULA MP-25.4 and DEX-4.4
1 INTRAVENA METHYL PREDNISOLONE(MP) 25 mg :
This 25 mg MP SHOULD be BACKED UPwith 4 unitsAPIDRA SCor IVMETHYL PREDNISOLONE(MP)50 mg : with 8 unitsNovorapid SCor IV
METHYL PREDNISOLONE (MP) 125 mg :with 20 units Novorapid SC / IV / PUMP
INTRAVENA DEXAMETHASON (DEX) 4 mg: BACKED UPwith 4 unitsAPIDRA SCor IV
INTRAVENA DEXAMETHASON (DEX) 8 mg: BACKED UPwith 8 units Novorapid SCor IV
INTRAVENA DEXAMETHASON (DEX) 16mg: BACKED UPwith 16units Novorapid SC/ IV
2
3
1
2
3
INTRAVENA METHYL PREDNISOLONE (MP) 25 mg :
Every 25 mg MP SHOULD be BACKED UPwith 4 units NOVORAPID SCor IV
INTRAVENA DEXAMETHASON (DEX) 4 mg : BACKED UPwith 4 units Novorapid SCor IV
1 Flacon 2 ml : 125 mg MP. Diluted with 3 ml NaCl 0.9%
5 ml with 125 MP . Thus : 1 ml Contains 25 mg MP
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Conclusion
Diabetes is a progressive disease that is increasing in prevalence in the world
Starting with basal insulin detemir is easy way to reach better glycemic control
In Indonesia, in real life clinical practice (A1chieve study) Levemir show significantimprovements in overall glycaemic control in terms of HbA1c, FPG and PPG.
Premixed insulin NovoMix is one option for insulin intensification, provide simple andconvenient for patients
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Thank You