Clinical study to investigate the effects of mitiglinide add-on therapy with pioglitazone in patients with type 2 diabetes and cardiovascular disease.

Clinical study to investigate the effects of mitiglinide add-on therapy with pioglitazone in patients with type 2 diabetes and cardiovascular disease. - Vascular endothelial function by mitiglinide add-on therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004480

Enrollment

Registered

2010-10-30

Start date

2010-04-01

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

Patients withtype 2 diabetes and cardiovascular disease or atherosclerosis-prone.

Interventions

dual treatment with mitiglinide (30 mg/day) and pioglitazone (15-30 mg/day) for 12 weeks monotherapy with pioglitazone (15-30 mg/day) alone for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: high-risk patients with cardiovascular disease with type 2 diabetes 1. pioglitazone usage (> 3 months) 2. HbA1c 6.5-8.0% (variance <0.5% in recent 2 months) 3. patients who agree the study dezine and protocol

Exclusion criteria

Exclusion criteria: 1. acute coronary syndrome (< 3 weeks) 2. moderate to severe heart failure (BNP > 200 pg/mL) 3. SU usage in recent 3 months 4. insulin usage 5. severe diabetic retinopathy 6. mitiglinide usage 7. impossible to use mitiglinide or pioglitazone 8. impossible to evaluate precise effects of mitiglinide or pioglitazone

Design outcomes

Primary

Measure	Time frame
Efficacy: Changes from baseline in vascular endothelial function Safety: adverse event and laboratory tests	—

Countries

Japan

Outcome results

None listed

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