Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs

Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs - Efficacy and safety of once daily insulin glargine therapy for people with type 2 diabetes inadequately controlled with DPP4 inhibitor and several OADs

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007375

Enrollment

100

Registered

2012-02-27

Start date

2011-11-01

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

Interventions

Add once daily injection of insulin glargine before breakfast Starting dose will be 2~20 unit and titrated according to FPG when the patients visit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients who were treated with OADs containing DPP4 inhibitor with HbA1c 7.0%<=HbA1c<10.0, Who can measure FPG before breakfast by SMBG

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1) Patients except type 2 diabetic patients. 2) Patients taking Probucol, vitamin E and/or vitamin C. 3) Alcoholic,or heavy drinker. 4) Patients operated malignant and gastro extraction. 5) Patients with serious complications of DM. Nephropathy:*. Retinopathy:** 6) Drug anaphylaxis patient. 7) Pregnant or patients who plan to carry, or currently breast-feeding woman. 8) Patients who were judged inappropriate to participate in this study by the doctor of study director or cooperative

Design outcomes

Primary

Measure	Time frame
Reduction of HbA1c Reduction of FPG	—

Secondary

Measure	Time frame
Achievement ratio of HbA1c below 6.5 and 7.0%. Change of BW	—

Countries

Japan

Contacts

Public ContactTakaaki Kobayashi

Tokyo Medical University The 3rd Department of Internal Medicine

03-3342-6111

Outcome results

None listed

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