Article
Reference
Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes after failure of oral therapy in a
real-world setting
PFOHL, Martin, et al .
Abstract
To evaluate the effectiveness and safety of initiating basal insulin-supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs).
PFOHL, Martin, et al . Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes after failure of oral therapy in a real-world setting. Diabetes, Obesity and Metabolism , 2020, vol. 22, no. 5, p. 759-766
DOI : 10.1111/dom.13952 PMID : 31903680
Available at:
http://archive-ouverte.unige.ch/unige:138892
Disclaimer: layout of this document may differ from the published version.
Supplementary Table 1 – Baseline concomitant diseases and lipidaemia (FAS-M12; n=721)
Data shown as mean ± standard deviation, if not otherwise specified; FAS-M12, full analysis set of patients with month 12 data available
Characteristic FAS-M12 N
Concomitant diseases Vascular disorders, n [%]
Nervous system disorders, n [%]
Renal and urinary disorders, n [%]
Eye disorders, n [%]
Cardiac disorders, n [%]
Endocrine disorders, n [%]
Metabolism and nutrition disorders, n [%]
Lipidaemia
Triglycerides [mg/dL]
Total cholesterol [mg/dL]
HDL cholesterol [mg/dL]
LDL cholesterol [mg/dL]
536 [74.3]
236 [32.7]
69 [9.6]
21 [2.9]
120 [16.6]
54 [7.5]
178 [24.7]
220.3±104.0 197.3±45.1
46.9±20.6 118.2±37.6
721 721 721 721 721 721 721
466 510 460 469
Supplementary Table 2 – Four-point SMBG blood glucose profiles at baseline and changes to month 6 and month 12 after initiation of Gla-300 (FAS-M12; n=721)
Timepoint Baseline Change to
month 6 P
value Change to
month 12 P value
mean±SD N mean±SD N mean±SD N
Morning preprandial [mg/dL]
Morning 2 h postprandial [mg/dL]
Lunch 2 h postprandial [mg/dL]
Dinner 2 h postprandial [mg/dL]
176.0±48.5 213.0±62.6 191.7±51.4 186.3±46.5
107 93 91 96
-40.4±54.4 -56.1±63.3 -48.7±46.9 -38.0±54.6
72 61 55 61
<0.0001
<0.0001
<0.0001
<0.0001
-47.8±43.5 -46.4±50.6 -33.2±56.9 -34.3±33.6
56 51 43 51
<0.0001
<0.0001 0.0004
<0.0001 SMBG, self-measured blood glucose; FAS-M12, full analysis set of patients with month 12 data available; SD, standard deviation; Gla-300, insulin glargine 300 U/mL
27.3%
6.9%
3.1%
5.3%
2.9%
0.3%
20.4%
8.5%
3.1%
0.8% 0.4% 2.4%
18.6%
30.4%
5.8%
3.2% 6.4% 2.2%
0.4%
19.8%
7.6%
1.7% 1.0%
0.4% 2.4%
18.7%
Met + DPP-4i Met + SGLT2i
Met + SGLT2i + DPP-4i Met + SU
Met + SU + DPP-4i Met + SU + SGLT2i Met monotherapy DPP-4i monotherapy SGLT2i monotherapy SU + DPP-4i
SU + SGLT2i SU monotherapy Others
B 12 months of Gla-300 treatment Baseline
A
Supplementary Figure 1 – Most often used combinations of oral antidiabetic drugs at baseline (A) and after 12 months of Gla-300 treatment (B) (FAS-M12; n=721); denominator for the percentages is the number of patients in the analysis set, i. e. percentage of patients including “unknown/missing data”; Others, other combinations or unknown; DPP-4i, dipeptidyl peptidase-4 inhibitor; FAS-M12, full analysis set of patients with month 12 data available; Gla-300, insulin glargine 300 U/mL;
SGLT2i, sodium-glucose cotransporter-2 inhibitor; SU, sulfonylurea
Supplementary Figure 2 – Most often prescribed non-insulin antiglycaemic drugs and fix ratio drug combinations at baseline (A) and after 12 months of Gla-300 treatment (B) (FAS-M12; n=721); AGI, alpha glucosidase
inhibitor; DPP-4i, dipeptidyl peptidase-4 inhibitor; FAS-M12, full analysis set of patients with month 12 data 55.2
29.7 21.8
13.5 15.8
3.3 2.9 1.7 1.1 1.0 0.3 0
10 20 30 40 50 60
70 Met DPP-4i
DPP-4i/Met SU
SGLT2i Glinides
GLP-1 RA TZD
Met/TZD SU/TZD
AGI 58.7
31.9 22.9
15.8 12.6
5.1 2.4 2.1 1.2 0.8 0.6 0
10 20 30 40 50 60
70 Met DPP-4i
DPP-4i/Met SU
SGLT2i Glinides
GLP-1 RA TZD
Met/TZD SU/TZD
AGI
Patients with at least one non-insulin antiglycaemic drug prescribed n=664 (92.1%); Total number of OAD prescribed n=1,054
Patients with at least one non-insulin antiglycaemic drug prescribed n=689 (95.5%); Total number of OAD prescribed n=1,111
P ro p or ti on o f p ati en ts [%] P ro p or ti on o f p ati en ts [%]
A Baseline B 12 months of Gla-300 treatment
-0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
-100 0 100 200 300 400 500 600 700 800
Achievem ent probability
Time to target achievement [days]
Not at target 721 418 57 1 0
0.35
180 365
0.58
279
Supplementary Figure 3A – Time to individualized HbA
1cor FPG target achievement after
initiation of BOT with insulin glargine 300 U/mL; brown: median time to target achievement; blue:
Kaplan-Meier estimate for target achievement after 6 and 12 months, respectively; FPG target,
fasting blood glucose ≤ 110 mg/dL (≤ 6.1 mmol/L); BOT, basal insulin supported oral therapy
-0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
-100 0 100 200 300 400 500 600
Duration probability
Duration of target achievement [days]
On target 436 148 3 1
. . . . . . . . . .
. 0.71
180 349
Supplementary Figure 3B – Duration of individualized HbA or FPG target achievement under
-0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
-100 0 100 200 300 400 500 600 700 800
Achievem ent probability
Time to target achievement [days]
Not at target 721 510 70 1 0
0.44
180 365
. . . . . . . . . . .
0.21
379
Supplementary Figure 4A – Time to individualized HbA
1ctarget achievement after initiation of BOT
with insulin glargine 300 U/mL; brown: median time to target achievement; blue: Kaplan-Meier
estimate for target achievement after 6 and 12 months, respectively; BOT, basal insulin supported oral
-0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
-100 0 100 200 300 400 500
Duration probability
Duration of target achievement [days]
0.81
On target 354 217 93 15 1
180 341
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