Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)

Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300) - Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029630

Enrollment

Registered

2017-10-19

Start date

2018-06-08

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 1 diabetes mellitus

Interventions

Intervention at glargine-U 300 cross over Intervention at degludec cross over

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 1 diabetes patients who were confirmed to have CPR of less than 0.2 ng / mL at least twice by a conventional measurement method 2) Long-acting or intermediate insulin injection once a day and MDI of super fast-acting or fast-acting insulin have been treated for more than 1 year 3) SMBG can be implemented 4) FGM can be implemented

Exclusion criteria

Exclusion criteria: 1)HbA1c > 9.0% 2)other medication to affect glucose concentarion 3)severe hypertension(Systolic blood pressure of 180 mmHg or more, diastolic blood pressure of 100 mmHg or more) 4)severe liver dysfunction (Increase of AST, ALT more than 2.5 times normal upper limit) 5)severe renal dysfunction (Cr > 2) 6)severe heart failure (NYHA>2) 7)Recent serious hypoglycemia, recent hospitalization due to ketoacidosis 8)retinopathy with high bleeding risk 9)pregnant or breast-feeding women 10)Cancer patient 11)psychological disorder 12) others inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Standard deviation of fasting blood glucose by SMBG	—

Secondary

Measure	Time frame
Nocturnal blood glucose fluctuation index by flash glucose monitoring	—

Countries

Japan

Contacts

Public ContactSakaguchi Kazuhiko

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

kzhkskgc@med.kobe-u.ac.jp81-76-382-5861

Outcome results

None listed

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

Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient&#39;s blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)