Starting Basal Insulin in New Decade

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Starting Basal Insulin in

New Decade

Dr Diana Novitasari SpPD KEMD FINASIM


RS St Elisabeth Semarang

MAT-ID-2100860-V.1 (07/2021)
T2DM is a progressive disease

Lifestyle + OADs
Obesity

Insulin resistance

β-cell function (%)


Basal insulin + OADs
+
Genetic Environmental
factors Titrate dose to reach/maintain glycaemic targets
factors Metabolic Syndrome
+ Basal and 1–3 injections of bolus or premix
Initiate
Beta cells dysfunction
Intensify for mealtime insulin
coverage
Optimise

Type 2 diabetes
“hyperglycemia” Intensif
y

Treatment optimisation and intensification

*In an observational, retrospective analysis of insulin-naïve patients (N=40,627) with T2DM initiating basal insulin in five European countries and the US.5 HRQoL,
health-related quality of life; QoL, quality of life; T2DM, Type 2 diabetes mellitus
1. Berard L, et al. Diabetes Obes Metab. 2018;20:301–308; 2. Khan H, et al. Prim Care Diabetes. 2011;5:251–255; 3. Hayes A, et al. Value Health. 2016;19:36–41; 4.
Cannon A, et al. J Manag Care Spec Pharm. 2018;24(9a Suppl):S5–S13; 5. Mauricio D, et al. Diabetes Obes Metab. 2017;19:1155–1164.
Keputusan untuk memulai Terapi Insulin
Algorithm of Type 2 Diabetes management in Indonesia (PERKENI, 2021)
GOAL THERAPY : HbA1c <7% (Individualised)

HEALTHY LIFESTYLE MODIFICATION


Entry HbA1c Entry HbA1c Entry HbA1c
<7.5% >7.5% >9%

MONOTHERAPY DUAL THERAPY SYMPTOMS


(combination of 2 drugs TRIPLE THERAPY
Metformin (combination of 3 drugs with NO YES
with different
mechanism) different mechanism)
SU/Glinid
SU/Glinid SU/Glinid DUAL INSULIN
AG-I If HbA1c is THERAPY

Metformin or other first line drug


Metformin or other first line drug
not < 7% in ±
AG-i If HbA1c is
TZD 3 months, AG-I not < 7% in 3 Other
OR

Second line drugs


proceed to If HbA1c is months, Agents
DPP-4i DUAL TZD not < 7% in 3 TZD proceed to
THERAPY months, ADD OR TRIPLE
SGLT-2i DPP-4i proceed to DPP-4i INTENSIFY THERAPY
TRIPLE Insulin
THERAPY Therapy
GLP-1 RA SGLT-2i (combination SGLT-2i
of 3 drugs)
Basal
Basal Insulin
Insulin ADD OR INTENSIFY
GLP-1 RA GLP-1 RA INSULIN

1. The selection and use of drugs consider drug cost, availability, effectiveness, cardiorenal benefits, safety profile, effects on body weight, and patients'
choice.
2. Management includes not only blood glucose, but also integrated management of other Cardio-Renal risk factors.
3. Some GLP-1 RA and SGLT-2i show benefits to patients with Atherosclerotic Cardiovascular Disease, Heart Failure, and Kidney Failure
comorbidities. Both classes are suggested as options for patients with mentioned comorbidities / complications.
4. If the HbA1C cannot be checked, then the average blood glucose is used as a guide which is then converted to HbA1C (Point 7 in algorithm
explanation).
FORNAS 2021 terbaru: insulin basal dapat digunakan pada pasien DMT2 dengan
HbA1c >7.5 % / GDS rerata >169 mg/dl

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Kenapa menggunakan Insulin Basal pada Pasien DM tipe 2?

Memperbaiki control Lebih fisiologis


Glikemik1

Profil kerja hampir tanpa


Resiko Hipoglikemia lebih
puncak hingga 24 jam2
rendah1
Basal
Insulin

Kenaikan berat Menurunkan


badan lebih kecil1 glukotoksisitas2

Kepatuhan lebih Regimen yang sederhana


tinggi1 dan mudah digunakan2

References: 1. Lau ANC, et al. CMAJ. 2012 Apr 17; 184(7): 767–776; 2. Philis-Tsimikas A. Am J Med. 2013 Sep;126(9 Suppl 1):S21-7.

6
Mengapa menggunakan insulin basal untuk inisiasi Insulin?

400
Gula darah puasa mewakili lebih dari 70% total kondisi 20
hiperglikemi pada level HbA1c > 10,2
T2DM
300

Plasma glucose (mmol/l)


Plasma glucose (mg/dl)
Most insulin is 15
initiated when
HbA1c >8.5%

100
200
% contribution to HbA1c

PPG
30% FPG 10
80
50% 45% 40% Hyperglycaemia due to an increase in fasting glucose
70%
60

40
50% 55% 60%
70% 100 5
20
30%
Normal
0
<7.3 7.3–8.4 8.5–9.2 9.3–10.2 >10.2 Meal Meal Meal
HbA1c range (%) 0 0
6 10 14 18 22 2 6
Time of day (hours)

Menurunkan gula darah puasa (fasting/basal) akan menurunkan


keseluruhan profil gula darah 24 jam
Monnier L, et al. 2003
Polonsky K, et al. N Engl J Med 1988;318:1231―1239.
Alasan utilisasi insulin yang kurang adekuat:
Pasien terlalu lama pada regimen OHO Multiple
OAD OAD dual OAD triple OAD plus
monotherapy combination combination insulin
Pernyataan ADA/EASD :
10 Jika target HbA1c (<7%) is tidak
tercapai dalam 3 bulan dengan
9
monoterapi dengan metformin +
8 modifiaksi gaya hidup,
Pertimbangkan “kombinasi 2 obat”.
7
The average time to initiation of
HbA1c (%)

2.9 years 7.2 years


6 insulin is ≥ 9 years
6.7 years 1,2 diantara pilihan terapi kombinasi
Duration of Diabetes dengan metformin, guidelines
Patients taking one OAD
menyatakan bahwa insulin basal
Median time from HbA1c cutoff of ≥8.0% to intensification with an additional adalah regimen dengan “efikasi
OAD was 1.6 years, respectively. tertinggi”2
Patients taking two OAD
Median time from HbA1c cutoff of ≥8.0% to intensification with an additional
OAD was 6.9 years, respectively1
Intensification with insulin Median time to intensification with insulin was 7.1,
6.1, or 6.0 years for those taking one, two, or three OADs. 1
OAD: Oral anti-diabetic Drugs; Hba1c: glycated hemoglobin
1. Khunti K, et al Diabetes Care. 2013 Nov;36(11):3411-7. 2. Inzucchi SE, et al. Diabetes Care 2015;38:140–9.

8
Inovasi basal insulin terus dilakukan untuk mendapatkan profil basal insulin
yang semakin fisiologis
Scientific/medical breakthrough Animal-derived insulin 1st generation basal insulin 2nd generaton basal insulin

First diabetic patient treated Development of pen-


1922 with bovine insulin
1985 delivery system

Crystallization of 2005 IDet


1926 insulin
1980 2000
1921 Introduction of basal Glargine 100
bolus concept
Discovery of insulin u/ml
from dog pancreas Ideg100
1978
1936 Synthetic production of
2018
First extended-action Genetic sequence of ‘human insulin’ through 2017
insulin produced insulin determined recombinant DNA
technology
(protamine zinc insulin)
1955 Glargine
300 u/ml 2021-beyond
1950 1963 Ongoing innovation and research
NPH insulin offer patients into technologies offer the
Introduction of insulin
better insulin coverage potential of new therapies that
pumps
can further improve management
of diabetes

Gla-100, insulin glargine 100units/mL; IDeg, insulin degludec, IDet, insulin detemir; NPH, neutral protamine Hagedorn.
Hirsch IB, et al. Endocr. Rev 2020;(41)5:733–755; Vecchio I, et al. Front. Endocrinol 2018;9:613
9
Depot formasi yang compact menghasilkan pelepasan insulin Gla-300 lebih stabil,
tanpa puncak, durasi kerja lebih lama, lebih dari 24 jam1

Gla-300
300 Units/mL

Reduction of
volume by 2/3

Insulin glargine
More compact More gradual
Smaller
SC depot with and slower
volume of
smaller release from
injection1 surface area1,2 depot surface1-4

Gla-100
100 Units/mL

For illustrative purposes only

1. Pettus J et al. Diabetes Metab Res Rev. 2016;32:478-96; 2. Adapted from Sutton G et al. Expert Opin Biol Ther. 2014;14:1849-60; 10
3. Steinstraesser A et al. Diabetes Obes Metab. 2014;16:873-6; 4. Becker RH et al. Diabetes Care. 2015;38:637-43
10
Gla-300 bekerja lebih lama hingga 36 jam dalam menurunkan gula darah
vs Gla100
3 160

Gla-100

Blood glucose (mg/dL)


Mean GIR (mg/min/kg)

140
2
Gla-100

120
Gla-300
1

100 Gla-300

0 6 12 18 24 30 36
0 6 12 18 24 30 36

GIR, glucose infusion rate Time, h

Kadar Gla-300 dalam darah lebih lama, bekerja Kadar Gla-300 mampu menurunkan gula darah lebih
hingga 36 jam vs Gla100 lama hingga 36 jam vs Gla100

Adapted from Becker RH, et al. Diabetes Care. 2015;38(4):637–643; Bailey TS, et al. Diabetes Metab. 2018;44(1):15–21.

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Profil Glukosa yang lebih stabil: time-in-range sebanding, variabilitas Glukosa lebih rendah dan
nocturnal hypoglycemia lebih rendah pada Gla-300 vs Gla-100 pada pasien DM tipe 1
Gla-300 vs Gla-100, overall
Continuous glucose monitoring (CGM) confirms whether PK/PD
205 Gla-300 Gla-100 Gla-100 differences translate to clinically relevant differences
195
glucose (mg/dL)

28 mg/dL
Gla-300
185
Mean (±SE)

14 mg/dL
175 Gla-300 vs Gla-100: Improved glycemic control, with less fluctuation
165
155 Reduced nocturnal confirmed* or severe hypoglycemia: 4.0 vs 9.0
145 events/pt-year rate ratio 0.45; 95% CI 0.24–0.82
135 24
0 2 4 6 8 10 12 14 16 18 20 22
Time (h)

Gla-300 by injection schedule


Gla-100 by injection schedule
205
Morning injection Evening injection 205
195 Morning injection Evening injection
glucose (mg/dL)

195

glucose (mg/dL)
185
Mean (±SE)

185

Mean (±SE)
175
165 175
155 165
155
145
Mean morning injection time: 08:32 h Mean evening injection time: 20:14 h 145
135 Mean morning injection time: 08:07 h Mean evening injection time: 20:29 h
0 2 4 6 8 10 12 14 16 18 20 22 135
0 2 4 6 8 10 12 14 16 18 20 22
*<54 mg/dL by self-monitored plasma glucose
16-week, exploratory, open-label, parallel-group, two-period crossover study (clinicaltrials.gov identifier NCT01658579), 59 adults with type 1 diabetes were randomized (1:1:1:1) to once-daily Gla-300 or Gla-100 given in the morning or evening (with crossover in the injection schedule)Average 24-h glucose
profiles during the last 2 weeks of each treatment period (CGM population; pooled data period A + B). The percentage of time within the target glucose range was comparable between the Gla-300 and Gla-100 groups. There was significantly less increase in CGM-based glucose during the last 4 h of the 24-h
injection interval for Gla-300 compared with Gla-100 (least squares mean difference −14.7 mg/dL [95% CI −26.9 to −2.5]; P = 0.0192).

Bergenstal RM, et al. Diabetes Care. 2017;40(4):554–560.


12
Gla-300 menunjukkan efektivitas dan konsistensi dalam menurunkan HbA1c dalam
Studi RCT
Non-inferior change in HbA1C for Gla-300 vs Gla-100 at Month 6 in the EDITION program
T2DM T1DM
EDITION 11 EDITION 22 EDITION 33 EDITION JP 24 EDITION 45 EDITION JP 16
BB BOT switch Insulin-naïve BOT switch BB BB
LSM difference
0.00% -0.01% 0.04% 0.10% 0.04% 0.13%
(-0.11 to 0.11) (-0.14 to 0.12) (-0.09 to 0.17) (-0.08 to 0.27) (-0.10 to 0.19) (-0.03 to 0.29)
(95% CI)
0.0
LSM HbA1C change from
baseline to Month 6, %

-0.30
-0.5 -0.45
-0,42 -0.44 -0.43
BB= Basal Bolus
-0.57 -0.56 -0.55 BOT= Basal-oral
Terapi
-0.83 -0.83 Gla-300
-1.0
Gla-100

-1.5 -1.42 -1.46

Modified intention-to-treat population; BB, basal-bolus therapy; BOT, basal-oral therapy; CI, confidence interval; LSM, least squares mean

1. Riddle MC, et al. Diabetes Care. 2014;37(10):2755–2762; 2. Yki-Järvinen H, et al. Diabetes Care. 2014;37(12):3235–3243; 3. Bolli GB, et al. Diabetes Obes Metab.
2015;17(4):386–394; 4. Terauchi Y, et al. Diabetes Obes Metab. 2016 Apr;18(4):366–374 (main article and Supplementary Table 2); 5. Home PD, et al. Diabetes Care.
2015;38(12):2217–2225; 6. Matsuhisa M, et al. Diabetes Obes Metab. 2016;18(4):375–383 (main article and Supplementary Table 1).

13
Gla-300 menurunkan resiko hipoglikemia pada berbagai regimen pengobatan diabetes dengan insulin
(inisiasi insulin, basal-oral terapi, basal bolus)

Confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia vs Gla-100 from baseline to Week 8
Relative risk and 95% CI based
on % of participants with ≥1 Nocturnal (00:00–05:59 h) Any time of day (24 h)
event of one confirmed (≤70 Favors Favors Favors Favors
mg/dL [≤3.9 mmol/L]) or T2DM studies Gla-300 Gla-100 Gla-300 Gla-100
severe hypoglycemia
EDITION 1 BB1 0.79 (0.64 to 0.98) 0.86 (0.78 to 0.94)
EDITION 2 BOT switch2 0.53 (0.39 to 0.72) 0.78 (0.69 to 0.89)

EDITION 3 Insulin naïve3 0.74 (0.48 to 1.13) 0.83 (0.67 to 1.03)


EDITION JP 2 BOT switch4 0.83 (0.45 to 1.52) 0.69 (0.52 to 0.91)
Gla-300
menunjukkan Relative risk (95% CI) Relative risk (95% CI)
BB= Basal Bolus
resiko BOT= Basal-oral Terapi
hipoglikemia T1DM studies
lebih rendah
EDITION 4 BB5 0.82 (0.70 to 0.96) 0.98 (0.92 to 1.04)
pada fase titrasi
EDITION JP 1 BB6 0.71 (0.56 to 0.91) 0.91 (0.84 to 0.99)

Relative risk (95% CI) Relative risk (95% CI)

1. Adapted from Riddle MC, et al. Diabetes Care. 2014;37(10):2755–2762; 2. Yki-Järvinen H, et al. Diabetes Care. 2014;37(12):3235–3243; 3. Bolli GB, et al. Diabetes Obes Metab.
2015;17(4):386–394; 4.Terauchi Y, et al. Diabetes Obes Metab. 2016;18(4):366–374 (main article and Supplementary Table 4); 5. Home PD, et al. Diabetes Care. 2015;38(12):2217–2225
(Supplementary Table 2); 6. Matsuhisa M, et al. Diabetes Obes Metab. 2016;18(4):375–383 (Supplementary Table 3).

14
Gla300 mengurangi kenaikan berat badan

Switching to Gla300 offers significant less weight gain


in patients who required titration

EDITION 2

35%
Less weight gain
with Gla300 in 6
months

Gla300
Gla100
Gla300
Gla100

Adapted from Ritzel et al Diabetes care Metab. 17:859, 2015 and RitzeL R et al EASD 2015 poster 975.
Yki-Järvinen H, et al. Diabetes Care. 2014;37(12):3235–3243

15
Gla-300 dapat digunakan oleh berbagai tipe populasi pasien diabetes

T1DM adult patients Gla-300 provides comparable glycemic control and reduced hypoglycaemia
(nocturnal) risk during the titration period vs Gla-100 in adults with T1DM1

Patients with impaired renal function Gla-300 provides comparable glycemic control and a reduced hypoglycemia risk vs
Gla-100 in T2DM patients regardless of renal function2

Older patients Gla-300 results in comparable reductions in HbA1C and low or lower risk of
documented symptomatic hypoglycemia vs Gla-100 in older patients with T2DM,
particularly those ≥ 75 years3
Pregnancy The use of Gla-100 or Gla-300 during pregnancy is not associated with any specific
adverse events4

Children, Adolescent Gla-300 provides similar glycemic control and comparable risk of hypoglycemia
and lower risk of severe hypoglycemia to Gla-100 in children and adolescents
aged 6–17 years with T1D5
Studi ORION pada pasien yang menjalankan puasa, Gla-300 menurunkan HbA1c
Pasien yang berpuasa dari pre- hingga post- Ramadan dengan insidens hipoglikemia yang rendah1

the use of glargine U300 in the hospital setting is as effective as glargine U100 for the
Inpatient Setting management of medical and surgical patients with T2D. Glargine U300 may decrease the
incidence of hypoglycemia in this population.7
• 1. Home PD, et al. Diabetes Obes Metab. 2018;20(1):121–128; 2. Escalada J, et al. Diabetes Obes Metab. 2018;20(12):2860–2868;
3. Ritzel R, et al. Diabetes Care 2018;41(8):1672–1680; 4. Bertolini M, et al. Poster presentation at EASD 2017; Abstract 937;
5. Danne T et al. Diabetes Care 2020;43:1512–9 6. Hassanein, M et al, Research and Clinical Pract, 2020 7. Pasquel FJ, et al.
Diabetes Care. 2020;43(6):1242-1248
Perbandingan basal insulin generasi kedua
PK/PD Insulin Glargine U300 vs Insulin Degludec


PK/PK profile

The within-day fluctuation of metabolic activity was 20% lower (p=0.047) for Gla-300 than iDeg

GLA 300 provides a more stable profile than degludec with less within-day fluctuations
Bailey T, et al. (abstract) presented at 14th World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease; 2016 Dec 1–3;
Los Angeles, California. Available from: http://journals.aace.com/doi/pdf/10.4158/1934-2403-23.1.1A. Date accessed: February 2017.
18
BRIGHT was the first head-to-head trial comparing Gla-
300 vs degludec 100 U/mL1

BRIGHT was a randomised, multicentre, open-label, non-inferiority


study comparing Gla-300 vs degludec 100 U/mL1

929
insulin-naïve patients with T2DM
24 weeks
on-treatment; the active titration period
inadequately controlled by OADs with or (Weeks 0–12), and the maintenance period
without GLP-1 receptor agonists1 (Weeks 13–24)1

What has Gla-300 shown compared


with degludec 100 U/mL in BRIGHT?
Comparable glycaemic control, meeting the primary endpoint* 1
Comparable hypoglycaemia** risk in the maintenance and full study period 1
Less hypoglycaemia** in the titration period†1

*For non-inferiority in HbA1c reduction;1 **Anytime (24 h) confirmed hypoglycaemia (≤70 and <54 mg/dL) and nocturnal (00:00–05:59 h) confirmed hypoglycaemia (≤70 mg/dL);1 †Titration period: 0–12 weeks.1
Degludec 100 U/mL, insulin degludec 100 U/mL; GLP-1, glucagon-like peptide 1; OADs, oral antidiabetic drugs; T2DM, Type 2 diabetes mellitus
1. Rosenstock J, et al. Diabetes Care. 2018;41:2147–2154.
Bagaimana data pengalaman penggunaan inisiasi &
beralih ke Gla-300 di dunia?
Gla-300 pada pasien T2DM yang tidak terkontrol OAD menunjukkan perbaikan control glikemik dan
hipoglikemia yang rendah

ATOS: Observational study of clinical effectiveness of Gla-300 initiation after OAD in insulin-naïve T2DM
(N=4527)in Asia, Middle East, North Africa, Latin America, and Eastern Europe

6 months 12 months
HbA1c change from baseline* (95% CI) -1.51 (-1.54, -1.47) -1.89 (-1.99, -1.80)

Hypoglycemia incidence (event rate PPY, %)


Any 0.99% (0.036) 1.19% (0.037) Symptomatic (≤70 mg/dL) 0.75% (0.026) 0.88% (0.027)
Symptomatic (≤54 mg/dL) 0.13% (0.003) 0.20% (0.004) Severe 0.04% (0.001) 0.04% (0.001)

• Data shown are mean ± SD and change from baseline is absolute mean. Mean baseline HbA1c was 9.3%. The interim analysis was undertaken when ≥50% of participants had 6-months’ follow-up data (cut-off: July 1, 2019). Safety analyses
were undertaken in the eligible population (N=4527; those meeting the inclusion/exclusion criteria who started Gla-300 ±30 days from study start). Efficacy analyses were undertaken in the evaluable population (n=3373; eligible patients with an
HbA1c assessment at Month 6, of whom n=612 had a HbA1c assessment at Month 12). The primary endpoint was proportion of patients at predefined individualized goals at month 6 but due to the observational nature of the study, data were
not available for each endpoint in all participants; as such, population numbers varied slightly for each endpoint. The 6-month period was defined as from the first treatment administration to visit 3 (Month 6) or treatment discontinuation,
whichever occurred first; the 12-month treatment period was defined as from the first treatment administration to visit 4 (Month 12) or treatment discontinuation, whichever occurred first. CI, confidence interval; FPG, fasting plasma glucose; SD,
standard deviation; SMPG, self-monitored plasma glucose; OAD, oral antidiabetic drugs; U, units.
• Glastyan GR, et al. Presented at ADA 2020; 1028-P

21
Beralih ke Gla-300 (dari basal insulin lain) menurunkan kejadian hipoglikemia yang membutuhkan
rawat inap dan kunjungan IGD pada pasien DMT2

Patients with hypoglycemia associated with Adjusted* hypoglycemia event rate associated with
hospitalization/ED encounter hospitalization/ED encounter
Adjusted* odds ratio = 0.58 LSM difference -0.10
P=0.001 P=0.041
8 0.35

Events/per patient per year


Patients with event (%)

7 0.3
6
7.0 0.31
0.25 32%
42%
5
0.2
4 0.21
3
4.0 0.15

0.1
2

1 0.05

0 0
Gla-300 Other BI Gla-300 Other BI

Following on from the DELIVER-1 pilot study, DELIVER-2 was a retrospective observational analysis of matched cohorts (matched at a 1:1 ratio on a propensity score based on baseline demographics and clinical characteristics) of patients with T2DM on prior basal insulin
who were switched to either Gla-300 or another basal insulin (Gla-100, insulin detemir or IDeg), US PHIE EMR database (March 2015 to March 2016) (n=1819 per cohort). At baseline, Gla-100 was the basal insulin in 71.4% of patients in the Gla-300 group and 73.0% of
patients in the other BI group. The remainder of patients in each cohort switched from IDet *Adjusted for baseline hypoglycemia event rate.
Zhou FL, et al. Diabetes Obes Metab 2018;20:1293–1297

22
Bagaimana inisiasi Gla300

• Pada pasien DM tipe 1: Gla-300 digunakan 1 kali sehari bersamaan dengan insulin
meal-time dan memerlukan titrasi dosis individual​
• Pada pasien DM tipe 2: Dosis inisiasi yang dianjurkan adalah 0.2 units/kg diikuti
dengan titrasi dosis individual  

Switching dari basal insulin lain ke Gla-300:​
– Insulin basal 1 kali sehari: sesuai dosis sebelumnya (unit-to-unit conversion​)
– Insulin basal 2 kali sehari: dosis Gla 300 yang direkomendasikan adalah 80% dari
total dosis harian insulin basal sebelumnya

Pemantauan metabolik yang ketat direkomendasikan selama switching dan di


minggu awal setelah switching

BPOM, PI LANTUS XR, 2021

23
Gla 300 dapat dititrasi menggunakan berbagai algoritme dengan efikasi yang baik

Penggunaan Gla-300 dalam berbagai algoritme titrasi Clinical trial


FPG target
Algorithm
Titration
(mg/dL) frequency
*
Fasting blood/plasma glucose (mg/dL)

220 (Based on median fasting


#RE SMPG from last 3 days)
200 F! ≥140: 6 U↑ Weekly
>100 to <140: 3 U↑ (no more
180 #RE EDITION 80–100
≥60 to <80: 3 U↓ often than 3
160 F! <60 or severe/multiple hypo: ≥3 days)
+6U U↓ or at investigator’s
140 discretion
#RE
120 F! >180: 4 U↑
AUTOMATI >130 to 180: 2 U↑
100 +2U X
90–130
70 to <90: 2 U↓
every 3 days
+1U <70: 4 U↓
80
Tar +1U/day until FPG is reached
60 get INSIGHT 80–100
-1U/day if below target
Daily
EDITION AUTOMATIX INSIGHT
(Weekly) (3 days) (Daily)

*Not specified in algorithm; **Dose adjustment >126 mg/dL not specified in algorithm

Gla-300 dapat dititrasi baik per hari, per 3 hari maupun per minggu dalam mencapai target FPG

• Adapted from: Riddle MC, et al. Diabetes Care. 2014;37:2755–62; Yki-Jarvinen H, et al. Diabetes Care. 2014;37:3735–43; Bolli GB, et al. Diabetes Obes Metab. 2015;17:386–94;
Edelman S, et al. ADA 77th Scientific Sessions 2017, late breaking poster 131-LB; Gerstein HC, et al. Diabet Med. 2006;23:736–42; Philis-Tsimikas A, et al. Adv Ther. 2013;30:607–22

24
Gla-300 lebih flexible dalam waktu pemberian

Pooled EDITION 1 and 2 substudies in T2DM (Months 6–9)


6-hour flexible
Flexible dosing* Fixed dosing Fixed dosing dosing time window
HbA1C,%
n=99 n=95 time

Month 6, mean (SD) 7.30 (0.93) 7.30 (0.96)


Month 6–9, Flexible dosing Flexible dosing
0.05 (0.06) 0.00 (0.07) time: time:
LS mean change (SE)
- 3 hours + 3 hours
LS mean difference 0.05
(95% CI) (–0.13 to 0.23)

Gla-300 may allow some flexibility in timing


injections until 6-hour dosing time window
to deal with the situational variability
experienced in daily life

*Flexible dosing time: Once-daily injection intervals of 24 ± 3 h

Adapted from Riddle M, et al. Diabetes Technol Ther. 2016;18(4):252–257.

25
Kesimpulan
Basal Insulin adalah dasar pengobatan diabetes karena progesivitas
diabetes yang akhirnya membutuhkan insulin
• Inisiasi dengan Insulin basal efektif • Gla-300 memiliki variabilitas lebih rendah 20%
menurunkan HbA1c dan GDP dengan dibandingkan Deg-100. Gla-300 memiliki efikasi
hanya sekali suntik. Penurunan GDP, akan sebanding dengan resiko hipoglikemia yang lebih
turut menurunkan GD2PP (Gula Darah 2 jam rendah vs Deg-100
Post prandial).
• Beralih ke Gla-300 (dari basal insulin lain)
• Gla-300 efektif untuk management pasien menurunkan kejadian hipoglikemia yang
T1DM dan T2DM dengan studi lengkap, membutuhkan rawat inap dan kunjungan IGD
mulai dari pasien umur 6 tahun, pasien pada pasien DMT2
CKD, hingga pasien tua dengan resiko
tinggi, dengan kenaikan berat badan lebih • Gla-300 mudah dalam penggunaan dengan waktu
sedikit injeksi yang lebih fleksibel yaitu hingga 6 jam
jendela waktu pemberian.
• Dosis inisiasi Gla-300 adalah 0.2 u/kg BB.
Untuk beralih dari basal insulin lain ke Gla-
300, menggunakan dosis sesuai
sebelumnya (1:1)
GLARGINE 300 U/ML TELAH MASUK DALAM FORNAS 2021 DAN DAPAT DIAKSES PASIEN
JKN PER 1 JAN 2022

Reference:
1. Keputusan Menteri Kesehatan Republik Indonesia, 2021, Formularium Nasional, 2021, Nomor HK.01.07/MENKES/6485/2021
2. BPOM, PI LANTUS XR, 2021
3. Yki-J¨arvinen H et al; Diabetes Care 2014;37:3235–3243
4. American Diabetes Association Diabetes Care 2021 Jan; 44 (Supplement 1): S111-S124.https://doi.org/10.2337/dc21-S009
MAT-ID-2101348 -V.1.0 (10/2021)

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