Unique ID issued by UMIN | UMIN000044126 |
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Receipt number | R000050388 |
Scientific Title | A retrospective observational study: effectiveness of iGlarLixi in treating T2DM patients in clinical practice in Japan |
Date of disclosure of the study information | 2021/05/10 |
Last modified on | 2022/05/30 21:19:28 |
A retrospective observational study of the effectiveness of SOLIQUA in T2DM patients
SPARTA Japan
A retrospective observational study: effectiveness of iGlarLixi in treating T2DM patients in clinical practice in Japan
SPARTA Japan
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To evaluate effectiveness of iGlarLixi on controlling HbA1c from baseline to 6 months after treatment initiation in routine clinical practice in Japan.
Safety,Efficacy
Change in HbA1c from baseline to 6 months after the initiation of iGlarLixi
Observational
18 | years-old | < |
Not applicable |
Male and Female
Adult Japanese patients with T2DM who met all of the following inclusion criteria will be enrolled into the study.
(1)Initiated iGlarLixi at least 6 months before data collection regardless of treatment continuation or discontinuation
(2)Have at least one HbA1c value recorded within 3 months prior to initiation of iGlarLixi
(3)Have body weight data recorded within 6 months prior to iGlarLixi initiation
(4)Have at least one HbA1c value recorded within 6 months after the initiation of iGlarLixi
(5)Signed informed consent
Patients who met any of the following exclusion criteria will be excluded from the study.
(1)Have a diagnosis of type 1 diabetes
(2)Age <18 years old at initiation of iGlarLixi
(3)Pregnant during the observation period
(4)Previously participated in any iGlarLixi clinical trials or enrolled in any clinical trial related to diabetes during the observation period
(5)Previously treated with IDegLira within 3 months prior to initiation of iGlarLixi
(6)Off label use of iGlarLixi (e.g., Administration other than before breakfast, administering twice a day, etc.)
460
1st name | Yasuo |
Middle name | |
Last name | Terauchi |
Yokohama City University Graduate School of Medicine
Department of Endocrinology and Metabolism
236-0004
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.
045-787-2639
terauchi@yokohama-cu.ac.jp
1st name | Public contact |
Middle name | |
Last name | SPARTA Japan public contact |
Sanofi K,K.
General medicine medical
163-1488
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
0120-109-905
Sanofi_Medical@sanofi.com
Sanofi K.K.
Sanofi K.K.
Profit organization
Sone Clinic EC
3-32-8, Shinjuku, Shinjuku-ku, Tokyo
03-6779-8166
naoki-kitazawa@cmicgroup.com
NO
2021 | Year | 05 | Month | 10 | Day |
Published
469
In Japanese T2D participants with suboptimal glycemic control in real-world settings, HbA1c decreased from baseline by 0.85% at 6 months after initiation of iGlarLixi.
The incidence proportion and rate of hypoglycemia were 14.4% and 0.78 event/person-year, respectively. No severe hypoglycemia was reported.
The incidence proportion and rate of GI AEs were 16.3% and 0.51 event/person-year, respectively.
2022 | Year | 05 | Month | 30 | Day |
Main results already published
2020 | Year | 12 | Month | 18 | Day |
2021 | Year | 02 | Month | 24 | Day |
2021 | Year | 06 | Month | 01 | Day |
2021 | Year | 09 | Month | 15 | Day |
2021 | Year | 10 | Month | 31 | Day |
2021 | Year | 11 | Month | 15 | Day |
2021 | Year | 11 | Month | 28 | Day |
Study institutions must be regular prescribers of iGlarLixi to ensure that the target population of 460 eligible patients can be met. In addition to this, study sites will be selected to include those expected to have the most complete datasets available, taking into geographically spread across Japan representing different regions.
The Principal Investigators at each study site will enroll eligible patients who meet the inclusion criteria and do not meet any of the exclusion criteria from patients with a recent visit. Recent visit enrollment in sequential order limits biases in patient selection by the Principal Investigators. In addition, limitations will be placed on the number of patients at each institution to prevent bias between institutions
2021 | Year | 05 | Month | 07 | Day |
2022 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050388
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