This document summarizes information about the basal insulin Toujeo and compares it to Lantus. It discusses Toujeo's flat and prolonged activity profile, its ability to lower HbA1c levels similarly to Lantus while reducing hypoglycemic events and weight gain. Real-world evidence shows patients switching to Toujeo experienced an average 0.96% drop in HbA1c without changing their basal insulin dose. Toujeo provides flexibility in dosing time and has the potential to improve glycemic control while minimizing side effects for patients.

1. Next Generation Basal Insulin
Lantus

2. 1. Yki-Jarvinen H, et al. (Poster #946) presented at EASD, Vienna, September 15–19 2014. Available from: http://www.easdvirtualmeeting.org/resources/19180. Date accessed: April 2015. 2. Riddle MC, et al. Diabetes Obes Metab.DOI: 10.1111/dom.12472. epub 2015. 3. Bergenstal R, et al. (Poster #949) presented at EASD, Vienna, September 15–19 2014. Available from:
http://www.easdvirtualmeeting.org/resources/18574. Date accessed: April 2015. 4. Yki-Jarvinen H, et al. Diabetes Care 2014;37:3235–3243. 5. Becker RH, et al. Diabetes Care 2015;38(4):637–643. 6. EU, Toujeo® Summary of Product Characteristics. February 2015. 7. Ritzel R et al. (Poster #963) presented at EASD, Vienna, September 15–19 2014. Available from:
http://www.easdvirtualmeeting.org/resources/18908. Date accessed: April 2015. 8. Gerstein HC, et al. New Eng J Med 2012;367:319–328. 9. Ritzel R et al. Diabetes Obes Metab 2015. 10. Shiramoto M et al. Diabetes Obes Metab 2015.11. Lantus® EU SPC, June 2013; 12Jeandidier N et al. Poster presentation at EASD 2014; Abstract 961 Available at:
http://www.easdvirtualmeeting.org/resources/18792 Accessed September 2014
Toujeo‫של‬ ‫המורשת‬ ‫את‬ ‫ממשיך‬Lantus

3. 3
‫לוואי‬ ‫לתופעות‬ ‫יעילות‬ ‫בין‬ ‫איזון‬ ‫נדרש‬ ‫בזאלי‬ ‫באינסולין‬ ‫בטיפול‬
1. Shar VN et al Diabetes Obes Metab. 2013
2. Giordana C. Minerva Endocrinol 2013

4. Israel quality indicators 008-2010
‫סוג‬ ‫סוכרת‬ ‫חולי‬2‫ל‬ ‫מתחת‬ ‫מטרה‬ ‫ליעד‬ ‫מגיעים‬ ‫אינם‬ ‫רבים‬-7%
4
‫בעלי‬ ‫שיעור‬‫רמת‬HbA1c‫נמוכה‬‫או‬‫ל‬ ‫שווה‬-7%‫סוכרת‬ ‫בחולי‬‫בני‬0–75‫שנה‬

5. ‫הסוכרתיים‬ ‫בקרב‬ ‫חשש‬ ‫הוא‬ ‫המשקל‬
1. Peyrot M, Skovlund. Poster presented at ADA 2014; Abstract 56-LB. Available at http://ada.scientificposters.com/epsSearchADA.cfm Accessed July 2014
• DAWN2: 8,274 patients with T1DM and T2DM from 17 countries
53.7 55.1 56.4 52.7 51.5
54.8 52.7
0
10
20
30
40
50
60
70
T2DM no
medication
T2DM
OADs
T2DM
insulin
T1DM T2DM no
medication
T2DM
OADs
T2DM
insulin
T1DM
Medication beliefs, mean (0=fully disagree; 100=fully agree)
“Insulin causes weight gain”“I feel very anxious about my weight”
Not
applicable

6. 6
‫באזלי‬ ‫באינסולין‬ ‫לטיפול‬ ‫דרישות‬
‫יעילות‬
‫קצר‬ ‫לטווח‬ ‫בטיחות‬(‫להיפוגליקמיה‬ ‫סיכוי‬)
‫ארוך‬ ‫לטוח‬ ‫בטיחות‬((CVD
‫למשקל‬ ‫השפעה‬

7. ‫מאינסולין‬ ‫החלפה‬‫בזאלי‬‫ל‬-Toujeo,‫האיזון‬ ‫בשיפור‬ ‫מלווה‬‫הגליקמי‬
• Real world evidence - retrospective, observational study of data obtained by physician
survey and from medical charts of patients with T2D, in the US, switching to Toujeo from
other basal insulins (mean duration of treatment with Toujeo – 4 months).
Adapted from Tong L. et al. AMCP Sep 2016 Poster
Mean HbA1c
before
initiation of Toujeo (n=176)
Mean HbA1c
after
initiation of Toujeo (n=70)
7.61%
8.57%
-0.96%
P<0.0001

8. ‫ה‬ ‫ברמות‬ ‫דומה‬ ‫ירידה‬-HbA1c‫לאחר‬6‫חודשים‬
7.0
7.2
7.4
7.6
7.8
8.0
8.2
8.4
LS mean difference at Month 6:
0.00 (95% CI –0.08 to 0.07) %
Toujeo
Lantus®
Mean (SE) HbA1C, % HbA1C, mmol/mol
Baseline Week 12 Month 6
53
55
57
59
61
63
65
67
69
• Data were pooled from EDITION 1,2,3 studies conducted in patients with T2DM
(n=2,400). Average A1c – 8.31%, BMI – 34.7kg/m^2, DM Duration - 12.7 years.
1. Ritzel R et al , Diabetes Obesity and Metabolism 17 : 859-867 2015

9. ‫ה‬ ‫ברמת‬ ‫משמעותי‬ ‫הבדל‬-A1c,‫מטופלי‬ ‫לטובת‬Toujeo‫לאחר‬12‫חודשים‬
Adapted from Ritzel R et al. Poster presentation at ADA 2015; Abstract 1030-P;
LS mean difference at Month 12:
–0.10 (95% CI –0.18 to –0.02) %
P=0.0174
8.8
8.0
7.4
7.0
BL W12 M9 M12
Mean (SE) HbA1C, %
M6
8.6
8.4
8.2
7.8
7.6
7.2
Toujeo
Lantus®

10. Hypoglycaemia Basal Insulin Dose
‫מאינסולין‬ ‫החלפה‬‫בזאלי‬‫ל‬-Toujeo,‫אירועי‬ ‫במספר‬ ‫בהפחתה‬ ‫מלווה‬
‫ההיפוגליקמיה‬‫האינסולין‬ ‫במינון‬ ‫שינוי‬ ‫ללא‬ ‫וזאת‬‫הבזאלי‬
Tong L. et al. AMCP Sep 2016 Poster
P<0.0001
0.75
0.17
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
Before Switch After Switch
HypoglycaemicEvents(npts-year)
0.7
0.61
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
Before Switch After Switch
DailyBasalInsulinDose(U/kg)
n = 159
P=0.1395
-77%
n = 169 n = 71 n = 95

11. Toujeo‫ל‬ ‫בהשוואה‬ ‫יותר‬ ‫וארוך‬ ‫שטוח‬ ‫פעילות‬ ‫פרופיל‬ ‫בעל‬ ‫הינו‬-Lantus
Becker RH et al. Diabetes Care 2015;38:637–643

12. EDITION 1-2-3 T2DM Pooled Analysis
‫ב‬ ‫בשימוש‬ ‫ההיפוגליקמיה‬ ‫היארעות‬-Toujeo‫במשך‬24‫שעות‬
Lantus
Toujeo
0%
10%
20%
30%
40%
50%
60%
70%
0 to 2 2 to 4 4 to 6 6 to 8 8 to 10 10 to 12 12 to 14 14 to 16 16 to 18 18 to 20 20 to 22 22 to 24
Clock time, hours
Patients with ≥1 confirmed (≤70 mg/dL [3.9 mmol/L]) or severe hypoglycemia, %
Lantus®
Nocturnal
hypoglycemia
Ritzel R et al. Poster presentation at EASD 2014; Abstract 963 Available at: http://www.easdvirtualmeeting.org/resources/18908 Accessed September 2014
0
10
20
30
40
50
60
70
SAGLB.DIA.14.06.0065a(1) / 2014.09

13. ‫ב‬ ‫בשימוש‬ ‫במשקל‬ ‫פחותה‬ ‫עלייה‬-Toujeo‫ל‬ ‫בהשוואה‬-Lantus
Mean (SE) weight change from baseline, kg
LS mean difference at Month 6:
–0.28 (95% CI –0.55 to –0.01) kg
P=0.039
1.0
–0.5
BL
0.5
0.0
W2 W4 W8 W12 M4 M6
Toujeo
Lantus®
1.5
LOV
1/Ritzel R et al , Diabetes Obes and Metab 17:859-867 , 2015
EDITION 1-2-3 T2DM Pooled Analysis

14. ‫ב‬ ‫בטיפול‬ ‫במשקל‬ ‫פחותה‬ ‫עליה‬-Toujeo
‫בהשוואה‬‫ל‬-Lantus‫מסוג‬ ‫סוכרת‬ ‫בחולי‬1
EDITION JP 1
LS mean difference at Month 6:
–1.0 (95% CI –1.5 to −0.5) kg
P=0.0003
U300
–1.0
0.0
1.0
–0.5
0.5
BL LOVM6W2 W4 W8 W12 M4
Mean (SE) weight change from baseline, kg
Lantus®
Terauchi Y et al. Poster presentation at EASD 2014; Abstract 976 Available at:
http://www.easdvirtualmeeting.org/resources/19078 Accessed September 2014

15. ‫המתן‬ ‫בזמן‬ ‫גמישות‬
Jeandidier N et al. Poster presentation at EASD 2014; Abstract 961 Available at: http://www.easdvirtualmeeting.org/resources/18792 Accessed September 2014
Toujeo‫ביום‬ ‫פעם‬ ‫ניתן‬,‫יום‬ ‫בכל‬ ‫שעה‬ ‫באותה‬ ‫רצוי‬.
‫במידת‬‫הצורך‬,‫את‬ ‫להזריק‬ ‫ניתן‬Toujeo‫עד‬3‫או‬ ‫לפני‬ ‫שעות‬‫הקבוע‬ ‫הנטילה‬ ‫זמן‬ ‫אחרי‬.
3+‫שעות‬
3-‫שעות‬
‫ההזרקה‬ ‫שעת‬
‫הקבועה‬

16. ‫ב‬ ‫טיפול‬ ‫התחלת‬-Toujeo

17. ‫הטיפול‬ ‫להצלחת‬ ‫הכרחי‬ ‫שלב‬ ‫היא‬ ‫טיטרציה‬

18. ‫המטופל‬ ‫של‬ ‫לצרכיו‬ ‫ומותאם‬ ‫משופר‬ ‫עט‬
Toujeo Israeli PIL 01/2016

19. ‫היום‬ ‫בסוף‬,‫היא‬ ‫המטרה‬‫ה‬ ‫רמות‬ ‫את‬ ‫להוריד‬-HbA1c‫לרמה‬
‫למטופל‬ ‫המותאמת‬
‫הפחתה‬
‫בהיפוגליקמיות‬
‫עליה‬ ‫פחות‬
‫במשקל‬
‫משופר‬ ‫עט‬
‫הזרקה‬ ‫נפח‬
‫קטן‬
‫פעילות‬ ‫פרופיל‬
‫ושטוח‬ ‫ארוך‬
‫הפחתה‬
‫של‬ ‫בתנודתיות‬
‫הסוכר‬ ‫רמות‬*
1. Yki-Jarvinen H, et al. (Poster #946) presented at EASD, Vienna, September 15–19 2014. Available from: http://www.easdvirtualmeeting.org/resources/19180. Date accessed: April 2015. 2. Riddle MC, et al. Diabetes Obes Metab. DOI: 10.1111/dom.12472. epub
2015. 3. Bergenstal R, et al. (Poster #949) presented at EASD, Vienna, September 15–19 2014. Available from: http://www.easdvirtualmeeting.org/resources/18574. Date accessed: April 2015. 4. Yki-Jarvinen H, et al. Diabetes Care 2014;37:3235–3243. 5. Becker
RH, et al. Diabetes Care 2015;38(4):637–643. 6. Toujeo Israeli SPC 01/2016 . 7. Ritzel R et al. (Poster #963) presented at EASD, Vienna, September 15–19 2014. Available from: http://www.easdvirtualmeeting.org/resources/18908. Date accessed: April 2015. 8.
Gerstein HC, et al. New Eng J Med 2012;367:319–328. 9. Ritzel R et al. Diabetes Obes Metab 2015.
‫בזמן‬ ‫גמישות‬
‫ההזרקה‬
‫רבים‬ ‫בפרמטרים‬ ‫התלוי‬ ‫מורכב‬ ‫נושא‬ ‫הינו‬ ‫איזון‬.‫בעזרת‬ ‫טיפול‬Toujeo‫רבים‬ ‫ביתרונות‬ ‫מלווה‬,
‫ה‬ ‫ברמות‬ ‫לשיפור‬ ‫יביאו‬ ‫אלו‬ ‫האם‬-Hba1c?
?HbA1c
‫וניסיון‬ ‫בטיחות‬
‫ב‬ ‫שנים‬ ‫רב‬-
Glargine
* In T1DM patients

20. Toujeo‫הבריאות‬ ‫בסל‬ ‫מוכלל‬‫מסוג‬ ‫לסוכרתיים‬1‫ומסוג‬2
(‫גיל‬ ‫מעל‬18(
http://www.old.health.gov.il/units/pharmacy/trufot/PerutSalTrufa.asp?RegNum=155%2031%2034440%2000 April 2016
‫מחיר‬
‫אריזה‬
‫למטופל‬:
44₪

21. ‫סיכום‬-Toujeo
1. Yki-Jarvinen H, et al. (Poster #946) presented at EASD, Vienna, September 15–19 2014. Available from: http://www.easdvirtualmeeting.org/resources/19180. Date accessed: April 2015. 2. Riddle MC, et al. Diabetes Obes Metab. DOI: 10.1111/dom.12472. epub
2015. 3. Bergenstal R, et al. (Poster #949) presented at EASD, Vienna, September 15–19 2014. Available from: http://www.easdvirtualmeeting.org/resources/18574. Date accessed: April 2015. 4. Yki-Jarvinen H, et al. Diabetes Care 2014;37:3235–3243. 5. Becker RH,
et al. Diabetes Care 2015;38(4):637–643. 6. EU, Toujeo® Summary of Product Characteristics. February 2015. 7. Ritzel R et al. (Poster #963) presented at EASD, Vienna, September 15–19 2014. Available from: http://www.easdvirtualmeeting.org/resources/18908.
Date accessed: April 2015. 8. Gerstein HC, et al. New Eng J Med 2012;367:319–328. 9. Ritzel R et al. Diabetes Obes Metab 2015.

22. ‫אדון‬X–‫כללים‬ ‫פרטים‬
24
•‫גיל‬-64
•‫סוג‬ ‫סוכרת‬ ‫חולה‬2
•‫כ‬ ‫מזה‬ ‫מאובחן‬-12‫שנים‬
70
27 88
140 mmHg
75mmHg

23. ‫אדון‬X–‫רפואית‬ ‫היסטוריה‬
25
•‫רקע‬ ‫מחלות‬
–HTN
–IHD
–Hyperlipidemia
•‫משפחתית‬ ‫היסטוריה‬
•‫סוכרת‬ ‫סיבוכי‬
–MicroalbuminuriaMild
–NPDRMild

24. ‫אדון‬XXXX–‫תרופתי‬ ‫טיפול‬
26
•‫סוכרת‬ ‫לאיזון‬ ‫נוכחי‬ ‫תרופתי‬ ‫טיפול‬
–Januet 1000/50x2/d
–Amaryl 3mgx1/d
•‫תרופתי‬ ‫טיפול‬‫נוסף‬
–Microporin100mg
–Lipitor40mg
–Tritace comp 5/12.5mg

25. ‫אדון‬X–‫גליקמיים‬ ‫פרמטרים‬
27
9.1% 180
230

26. ‫אדון‬X–‫סוכרים‬ ‫מעקב‬ ‫טבלת‬
28

27. ‫אדון‬XXXX–‫פרמטרים‬‫גליקמיים‬
29
‫מטרה‬ ‫יעדי‬
6.5% 80-130
140-180

28. ‫אדון‬X–‫התרופתי‬ ‫הטיפול‬ ‫בבחירת‬ ‫שיקולים‬
30
•‫כלליות‬ ‫הערות‬
•‫יעילות‬
•‫בטיחות‬
•‫למשקל‬ ‫השפעה‬
•‫טיפוליות‬ ‫אופציות‬
–GLP1
–Insulin
–SGLT2

29. ‫אדון‬X–‫ביקור‬ ‫סיכום‬
31
•‫שהופסק‬ ‫תרופתי‬ ‫טיפול‬
–DDP4
–SU
•‫טיפול‬‫שהותחל‬ ‫תרופתי‬
–‫בזאלי‬ ‫אינסולין‬Toujeo
–SGLT2

30. ‫אדון‬X–‫גליקמיים‬ ‫פרמטרים‬
32
7.1% 110
170
26 86 130mmHg
75mmHg

31. 33
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