Long-term study on combinational therapy of SMP-508 with dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221738

Enrollment

Registered

2012-03-09

Start date

2012-03-09

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

Interventions

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

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 sitagliptin continuously at a fixed dose -Patients whose HbA1c level is 6.9% <= HbA1c (NGSP) <= 9.4% and is stable over 4 weeks -Patients aged 20 or older -Outpatients etc.

Exclusion criteria

Exclusion criteria: -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 Final visit	—

Secondary

Measure	Time frame
Efficacy: Confirmation of therapeutic target etc Final visit and every evaluation visit	—

Outcome results

None listed

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