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A retrospective observational study of the effectiveness of SOLIQUA in T2DM patients

A retrospective observational study: effectiveness of iGlarLixi in treating T2DM patients in clinical practice in Japan - SPARTA Japan

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000044126
Enrollment
460
Registered
2021-05-10
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Sponsors

Sanofi K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.)

Design outcomes

Primary

MeasureTime frame
Change in HbA1c from baseline to 6 months after the initiation of iGlarLixi

Countries

Japan

Contacts

Public ContactPublic contact SPARTA Japan public contact

Sanofi K,K. General medicine medical

Sanofi_Medical@sanofi.com0120-109-905

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026