Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor

Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor - Prospective, randomized, open-label, clinical trial comparing the different Sufonyl Urea(SU) combination with DPP4 inhibitor

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003006

Enrollment

Registered

2010-01-09

Start date

2011-03-01

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

Diabetes Mellitus

Interventions

after using gliclazide for 3 months, then substitute to glibenclamide after using glibenclamide for 3 months,then substitute to gliclazide after glimepiride for 3 months, then substitute to gliclazide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type2 Diabetes initiated to use sitagliptin(DPP4 inhibitor) and mean HbA1c 6.5%-7.5% for 3months and when gliclazide, daily dose within 40mg when glimepiride, daily dose within 1 mg when glibenclamide, daily dose within 1.25 mg

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to sulfonyl urea or sitagliptin 2.During the pregnancy and nursing 3. Severe renal dysfunction (serum creatinin>2.0mg/dl) 4. Severe liver dysfunction (AST, ALT>50IU/ml) 5. 6.Inadequate to entry this study

Design outcomes

Primary

Measure	Time frame
Diabetic Control (HbA1c, 1,5AG) beta cell function (proinsulin/ insulin ratio, CPR index)	—

Secondary

Measure	Time frame
systolic BP, diastolic BP LDL-cho, HDL-cho, TG	—

Countries

Japan

Contacts

Public ContactKazuhiko Sakaguchi

Kobe University Graduate School of Medicine Division of Diabetes,Metabolism and Endocrinology, Department of Internal Medicine

kzhkskgc@med.kobe-u.ac.jp

Outcome results

None listed

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