Long-term study on combinational therapy of SMP-508 with metformin in patients with type 2 diabetes mellitus

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221167

Enrollment

120

Registered

2010-07-23

Start date

2010-07-23

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 whose blood glucose levels are not adequately controlled by metformin in addition to diet and exercise therapies

Interventions

investigational material(s) Generic name etc : SMP-508 (repaglinide) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus who participated in the previous study "Phase 3 study on combinational therapy of SMP-508 with metformin in patients with type 2 diabetes mellitus", and meet all of the following requirements. -Patients who underwent the surveys, observations, and tests, etc. scheduled to be conducted in week 16 of the previous study. -Patients who, prior to admission to the study, voluntarily agree to participate in the study after receiving an explanation of the study objectives, methods, and potential risks, -Patients who provide written informed consent.

Exclusion criteria

Exclusion criteria: -Women who are pregnant or have a potential of pregnancy during the study, women who are at risk of pregnancy due to lack of appropriate contraceptive measures, or lactating mothers -Patients who will require surgery. -Patients whom the investigator or subinvestigator considers to be unsuitable for administration to the study for any other reason.

Design outcomes

Primary

Measure	Time frame
Efficacy: HbA1C etc	—

Outcome results

None listed

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