UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044126
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Sanofi K.K.

Institute

Department

Personal name



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

Value
https://center6.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