UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective observational study of the effectiveness of SOLIQUA in T2DM patients
Acronym	SPARTA Japan
Scientific Title	A retrospective observational study: effectiveness of iGlarLixi in treating T2DM patients in clinical practice in Japan
Scientific Title:Acronym	SPARTA Japan
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effectiveness of iGlarLixi on controlling HbA1c from baseline to 6 months after treatment initiation in routine clinical practice in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c from baseline to 6 months after the initiation of iGlarLixi
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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.)
Target sample size	460

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.
TEL	045-787-2639
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Public contact Middle name Last name SPARTA Japan public contact
Organization	Sanofi K,K.
Division name	General medicine medical
Zip code	163-1488
Address	3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	0120-109-905
Homepage URL
Email	Sanofi_Medical@sanofi.com

Sponsor
Institute	Sanofi K.K.
Institute
Department

Funding Source
Organization	Sanofi K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sone Clinic EC
Address	3-32-8, Shinjuku, Shinjuku-ku, Tokyo
Tel	03-6779-8166
Email	naoki-kitazawa@cmicgroup.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	469
Results	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.
Results date posted	2022 Year 05 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 12 Month 18 Day
Date of IRB	2021 Year 02 Month 24 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2021 Year 09 Month 15 Day
Date of closure to data entry	2021 Year 10 Month 31 Day
Date trial data considered complete	2021 Year 11 Month 15 Day
Date analysis concluded	2021 Year 11 Month 28 Day

Other

Other related information

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

Management information
Registered date	2021 Year 05 Month 07 Day
Last modified on	2022 Year 05 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050388