A Postmarketing Clinical Study of Repaglinide in Combination with Insulin in Patients with Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223173

Enrollment

100

Registered

2016-04-19

Start date

2016-05-10

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

Interventions

investigational material(s) Generic name etc : Repaglinide INN of investigational material : Repaglinide Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus who meet the following requirements -Patients who have been on a fixed regimen of diet and exercise therapies -Patients who are on a fixed dosage regimen of long-acting insulin -Patients whose HbA1c level is 7.0% <= HbA1c <= 10.0% and is stable over 4 weeks -Patients aged 20 or older -Outpatients etc.

Exclusion criteria

Exclusion criteria: Patients with hepatic impairment Patients with renal impairment Patients with cardiac diseases Patients with severe hypertension etc.

Design outcomes

Primary

Measure	Time frame
efficacy HbA1c level Change from baseline at Week 12	—

Secondary

Measure	Time frame
safety Proportion of patients who achieved a therapeutic target for diabetes mellitus etc. At each evaluation time point	—

Countries

Japan

Outcome results

None listed

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