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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044126
Receipt No. 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 2021/07/09

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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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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 No longer recruiting
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 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2021 Year 07 Month 09 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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