An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus

An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus - An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025122

Enrollment

Registered

2017-01-01

Start date

2016-12-02

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

Insulin glargine U300 will be administered daily for six months. Glargine U300 will be started at the same dose as glargine U100 administered before switching. The dosage of glargine U300 will be adju

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients with type 2 diabetes who is administered insulin glargine U100 for over three months

Exclusion criteria

Exclusion criteria: Patients whose medications for diabetes (kinds or dosages of insulin, GLP-1 agonists or oral hypoglycemic agents) have been changed in last two months

Design outcomes

Primary

Measure	Time frame
Level of glycohemoglobin (HbA1c) at six months after switching basal insulin	—

Secondary

Measure	Time frame
Fasting blood glucose, body weight, frequency and severity of hypoglycemia, circadian variation in blood glucose (M Value), dosage of insulin, results of the questionnaire about quality of life (QOL) and device convenience	—

Countries

Japan

Contacts

Public ContactRie Jo

Kanagawa-ken Keiyu-kai Keiyu hospital Department of internal medicine

r.oga925@nifty.com045-221-8181

Outcome results

None listed

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