Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes

Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes - ESSENTIAL STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017625

Enrollment

Registered

2015-05-19

Start date

2014-12-01

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

Type 2 diabetes mellitus

Interventions

Patients with uncontrolled blood sugar after middle dose of DPP-4I treatment in addition to coronary artery disease and/or high risk are enrolled. The patients receive combination with middle dose of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with HbA1c = or > 7.0 % after treatment of middle dose of DPP-4I more than 8 weeks. 2.Patients with coronary artery disease and/or high risk. 3.Patients who give their informed consent to participate for the present study.

Exclusion criteria

Exclusion criteria: 1.Severe ketosis and diabetic coma 2.Type 1 diabetes mellitus 3.Severe liver dysfunction 4.Severe renal dysfunction 5.Pregnancy or lactation in women 6.Patients with a history of allergy to any component of the study medications 7.Patients corresponding to the contraindication of study medications 8.Ineligible patients according to the judgment by physician

Design outcomes

Primary

Measure	Time frame
HbA1c levels	—

Secondary

Measure	Time frame
glycoalbumin, FMD, blood pressure, biochemical parameters (including inflammation markers and urinary albumin)	—

Countries

Japan

Contacts

Public ContactShin-ichiro Miura

Fukuoka University Hospital Department of Cardiology

miuras@cis.fukuoka-u.ac.jp092-801-1011

Outcome results

None listed

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