Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).

Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy). - Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030648

Enrollment

Registered

2018-01-01

Start date

2018-01-04

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

Interventions

Deguldec/Aspart is administered twice in the morning and evening, and the dosage is adjusted to fix the unit going to pre-breakfast and pre-dinner with the goal of 100-130mg/dl. FGM (Flash Glucose Mo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diabetic patients who are needed to glycemic contro

Exclusion criteria

Exclusion criteria: 1.Serious ketosis, history of diabetic coma or precoma 2.Pregnancy or lactation and patients scheduled 3.Serious infection, trauma, undergo surgery 4.Receiving steroid therapy. 5.Severe liver dysfunction 6.Type 1 diabetes 7.Hypersensitivity to degludec/aspart, glargin, glulisine. 8.History of malignancy or malignancy. 9.Judged to be unsuitable for participation for medical reasons.

Design outcomes

Primary

Measure	Time frame
Percentage of time with in the predefined FGM glucose range of 70-179mg/dl(normal range).	—

Secondary

Measure	Time frame
Percentage of time with in the predefined FGM glucose range of >180mg/dl (hyperglycemia range) <70mg/dl(hypoglycemia range) <54mg/dl(severe hypoglycemia range) Nocturnal hypoglycemia(0:00-5:59) mean glucose level,SD-value,CV-value,Mean Amplitude of Glycemic Excursions,M-value,MODD	—

Countries

Japan

Contacts

Public ContactYuji Kawaguchi

Minami Osaka hospital Internal medicine

y.kawaguchi@minamiosaka.com06-6685-0221

Outcome results

None listed

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