Long-term Effects of Imeglimin on Japanese Patients with Type 2 Diabetes Mellitus

A retrospective, 12-month longitudinal cohort study of imeglimin 1,000 mg twice daily evaluating glycemic control, beta-cell function, and glycemic variability in Japanese patients with type 2 diabetes mellitus - LITE study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057714

Enrollment

Registered

2025-05-01

Start date

2024-10-28

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 Mellitus (T2DM)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: Adults aged 20 years or older. Diagnosis: Japanese patients with a confirmed diagnosis of type 2 diabetes mellitus (T2DM). Start of treatment: Patients must start treatment with 1,000 mg of Imeglimin twice daily between June 1, 2021 and March 31, 2025. Duration of treatment: Patients must continue using Imeglimin for at least 52 weeks (12 months) after starting treatment. Data availability: Sufficient clinical and laboratory data required for primary analysis, such as HbA1c, GA, and C-peptide reactivity index (CPI) at baseline and each follow-up time (1, 3, 6, and 12 months), must be available.

Exclusion criteria

Exclusion criteria: Diagnosis of type 1 diabetes: Patients who have been clearly diagnosed with type 1 diabetes. Pregnant or breastfeeding: Pregnant or breastfeeding women. Renal impairment: Patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2. Severe infection: Patients with a severe infection requiring treatment. Pre- or post-operative condition: Patients in a state of acute physical stress, such as before or after surgery. Data deficient: Patients for whom sufficient clinical and test data required for primary analysis cannot be obtained.

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin A1c (HbA1c) from baseline to 52 weeks	—

Secondary

Measure	Time frame
Change in the glycated albumin to HbA1c ratio (GA/HbA1c) from baseline to 52 weeks Change in C-peptide reactivity index (CPI) from baseline to 52 weeks	—

Countries

Japan

Contacts

Public ContactYohei Fujita

Osaka General Medical Center Department of Diabetes and Endocrinology

fujita.yohei93@gmail.com0666921201

Outcome results