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1. LixiLan-L
SAID.SQA.19.04.0145/(04/19)
Hanya Metformin yang dilanjutkan pada fase run-in
DESIGN: Randomized, open-label, parallel-group, 30-week treatment trial
6-week
run-in phase
Insulin glargine 100 U/mL (iGlar) Metformin
Dosis insulin disesuaikan untuk mencapai GD Puasa
target (80 to 100 mg/dL) and capped to 60 U/day pada kedua
groups
iGlarLixi Metformin
30-minggu treatment period
Pasien Diabetes tipe 2
dengan
Basal insulin >6 bulan
Dosis stabil 15 40 U/d
± OADs
HbA1c 10%
GD puasa 200
mg/dL n=367
7% HbA1c %
GD Puasa
Dosis iGlar
n=369
Inisiasi iGlar
dan atau titrasi
FPG, fasting plasma glucose; HbA1c, glycated hemoglobin
OAD, oral antidiabetic drug; U, unit
Aroda VR, et al. Diabetes Care 2016;39:1972 80

2. iGlarLixi adalah self-injected, diberikan 1x sehari, pemberian dalam 1 jam (0 60
min) sebelum sarapan
Setelah 2 minggu dalam dosis stabil, dosis di titrasi sekali dalam seminggu untuk
mencapai target puasa SMPG of 4.4 to 5.6 mmol/L (80 to 100 mg/dL), mencegah
hipoglikemia.
Pasien di
random ke
iGlarLixi
PEN B
Dosis iGlar dari 30 U hingga 60 U; dosis awal 30 U
PEN A
Dosis iGlar dari 10 hingga 40 U; dosis awal 10 U per hari
Dosis iGlar
U/day
sebelum
randomisasi
Dosis iGlar
<30 U/day
sebelum
randomisasi
SMPG, self-measured plasma glucose
Aroda VR, et al. Diabetes Care 2016;39:1972 80
For statistical analysis of the study endpoints, a step-down
testing procedure was applied to control for type 1 error
PPG, postprandial glucose
PRIMARY
Superioritas dari iGlarLixi dibandingkan iGlar 100 U/mL dalam perubahan HbA1c pada minggu ke 30
SECONDARY
Superioritas dari iGlarLixi dibandingkan iGlar pada:
2 jam perjalanan glukosa plasma
Berat badan
7-point SMPG
Persentase pada pasien dengan HbA1c <7% dan tanpa peningkatan berat badan
Dosis iGlar
Persentase pada pasien dengan HbA1c <7% dan tanpa peningkatan berat badan dan/atau tanpa hipoglikemi simptomatik
Gula darah Puasa
Tambahan secondary endpoints termasuk:
Persentase responden dengan HbA1c <7% dan
Persentase pasien dengan HbA1c <7%, tanpa kenaikan berat badan pada minggu 30 and tidak ada resiko hipoglikemia
simptomatik
SAFETY
Didokumentasi hipoglikemi simptomatik
Kejadian efek samping
Aroda VR, et al. Diabetes Care 2016;39:1972 80

3. iGlarLixi
(n=367)
iGlar
(n=369)
Usia (years) 59.6 (9.4) 60.3 (8.7)
Wanita (%) 55.0 51.5
Caucasian/Black (%) 92/5 92/6
Berat badan (kg) at Baseline 87.7 (14.5) 87.1 (14.8)
BMI (kg/m2) at Baseline 31.3 (4.3) 31.0 (4.2)
Durasi Diabetes (years) 12.0 (6.6) 12.1 (6.9)
Durasi penggunaan Basal Insulin (years) 3.1 (3.1) 3.3 (3.1)
Jenis Basal insulin at Screening (%)
iGlar 64 65
Detemir 13 15
NPH 23 20
OAD use at Screening (%)
None 5 5
Metformin 46 52
Sulfonylurea (SU) 4 4
DPP-4 inhibitor 1 1
Metformin + SU 37 32
Metformin + DPP-4 inhibitor 5 5
BMI, body mass index; DPP-4, dipeptidyl peptidase 4;
NPH, neutral protamine Hagedorn insulin; SU, sulfonylurea
Aroda VR, et al. Diabetes Care 2016;39:1972 80
iGlarLixi
(n=367)
iGlar
(n=369)
HbA1c (%)
Screening 8.5 8.5
Baseline 8.1 8.1
FPG, mmol/L
Screening 7.9 8
Baseline 7.3 7.4
iGlar dose (U)
Start of run in 27.3 27.7
End of run in 35.0 35.2
Aroda VR, et al. Diabetes Care 2016;39:1972 80

4. 6.0
6.5
7.0
7.5
8.0
8.5
9.0
0.62
iGlar
HbA1c selama studi (%)
Modified intent-to-treat population
*Weighted average of proportion difference between treatment groups
BL, baseline; CI, confidence interval; HbA1c, glycated hemoglobin; LS, least squares; LOCF, last observation carried forward; S, screening;
SE, standard error
LS mean difference
95% CI, p-value
0.52 ( 0.633 to 0.397)
p<0.0001
iGlarLixi
6.0
6.5
7.0
7.5
8.0
8.5
9.0
Week
iGlarLixi
iGlar
6.9%
7.5%
S BL 8 12 24 30 30
LOCF
1.13LS mean change
HbA1c <7% HbA1c
25.5%*
95% CI:
18.9% 32.1%
p<0.0001
19.8%*
95% CI:
13.9% 25.6%
p<0.0001
iGlarLixi
iGlar
55
34
30
14
0
10
20
30
40
50
60
70
Target HbA1c minggu ke 30
2
1
1
2
3
0
BL 4 8 12 18 24 30 30
LOCF
Time (weeks)
iGlarLixi
iGlar
+0.7 kg
0.7 kg
Body weight (kg) change
from baseline to Week 30
-85.1
-70.2
-25.1
-8.4
95% CI: 70.7 to 52.9
p<0.0001
61.8*
2-hr PPGa (mg/dL) Excursiona (mg/dL)
60.0
95% CI: 70.1 to 50.0
Modified intent-to-treat population; ANCOVA for PPG analyses; MMRM for body weight analyses
aStandardized liquid breakfast meal
*LS mean difference vs iGlar
ANCOVA, analysis of covariance; CI, confidence interval; LOCF, last observation carried forward; LS, least squares; MMRM, mixed-effect model with
repeated measures; PPG, postprandial glucose; SE, standard error

5. Safety population
E/p-y, event/patient-year; GI, gastrointestinal
Documented symptomatic
hypoglycemia
E/p-y 0.02 < 0.01
iGlarLixi
(n = 469)
iGlar
(n = 467)
Nausea 38 (10.4) 2 (0.5)
Discontinuation 4 (1.1) 0
Vomiting 13 (3.6) 2 (0.5)
Discontinuation 2 (0.4) 0
Diarrhea 16 (4.4) 10 (2.7)
Discontinuation 0 0
All data are n (%)
Efek samping GI
iGlarLixi
iGlar
40
42.5
0
10
20
30
40
50
34.2
31.7
19.9
13.4
18.6
0
10
20
30
40
50
60
70
9.0
HbA1c <7% tanpa peningkatan
berat badan di minggu ke 30
HbA1c <7% tanpa peninmgkatan
berat badan di minggu 30 dan
Tanpa hipoglikemia
didokumentasi
HbA1c <7%
tanpa hipoglikemi
didokumentasi
20.8%*
95% CI: 15.0 to 26.7
p<0.0001 13.2%*
95% CI: 7.1 to 19.3
10.9%*
95% CI: 5.9 to 16.0
p<0.0001
mITT population
*Weighted average of proportion difference between
treatment groups; No p-value available as comparison not
specified in step-down testing procedure
Aroda VR, et al. Diabetes Care 2016;39:1972 80
iGlarLixi (n=366)
iGlar (n=365)

6. 0
5
10
15
20
25
30
35
40
45
50
Week
Aroda V, et al. ADA 2016 congress, scientific sessions webcast. Available at:
http://professional.diabetes.org/webcasts-ss2016, last accessed 10 May 2017
Average daily Insulin dose (U)
1 2 3 4 5 6 7 8 9 101112 15 18 21 24 27 30 30
LOCF
Run-in
start Randomization
-4
mITT population
iGlarLixi (n=366)
iGlar (n=365)
iGlar dose (U)
iGlarLixi
(n=365)
iGlar
(n=365)
Start of run-in 28 29
End of run-in 35 35
Week 30 (LOCF) 46 47
*LS mean change in HbA1c from baseline to Week 30.
Proportion of patients affected by documented symptomatic hypoglycemia
- vs iGlar-treated groups.
Mean change in weight from baseline to Week 30.
Proportion of patients who discontinued iGlarLixi treatment as a result of gastrointestinal (GI)
treatment-emergent adverse events.
1. Aroda VR et al. Diabetes Care. 2016;39:1972-1980.
Penurunan HbA1c yang signifikan pada minggu ke 30 1.1%*
Similar Hipoglikemia 40.0 vs 42.5%
Tanpa peningkatan berat badan 0.7 kg
Efek samping GI yang lebih rendah dibandingkan dengan
lixisenatide, yang menyebabkan penghentian pengobatan
1.1%§