Phase 3 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-jRCT2080221166

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 meet the following requirements -Patients who have been on a fixed regimen of diet and exercise therapies -Patients who have been taking metformin continuously at a fixed dose -Patients whose HbA1C level is 6.5% <= HbA1C <= 9.0% and is stable over 4 weeks -Patients aged 20 or older -Outpatients etc.

Exclusion criteria

Exclusion criteria: -Patients with history of lactic acidosis -Patients with hepatic dysfunction -Patients with renal dysfunction -Patients with cardiac diseases -Patients with severe hypertension etc.

Design outcomes

Primary

Measure	Time frame
Efficacy: HbA1C etc	—

Outcome results

None listed

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