The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections

The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections - The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061951

Enrollment

Registered

2026-06-18

Start date

2026-06-22

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes 2. Patients aged 20 to 75 years at the time of obtaining informed consent 3. Patients who have been receiving continuous treatment with long-acting insulin and either ultra-rapid-acting or rapid-acting insulin for at least 12 weeks at the time of obtaining informed consent 4. Patients with an HbA1c level of 6.0% or higher but less than 10.0% at the time of obtaining informed consent 5. Patients who have the capacity to consent to participation in this study and are able to understand the consent form and other explanatory documents

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes 2. Patients with a history of diabetic ketoacidosis within 90 days of obtaining informed consent 3. Patients with a history of hospitalization due to myocardial infarction, stroke, unstable angina, or transient ischemic attack within 180 days of obtaining informed consent 4. Patients with a history of pancreatic disease that affects blood glucose control 5. Patients with dementia 6. Pregnant women, women who may be pregnant, women planning to become pregnant, and breastfeeding women 7. Patients whom the attending physician has determined to have poor adherence 8. Any other patients whom the attending physician has determined to be unsuitable for participation in this study

Design outcomes

Primary

Measure	Time frame
Change in HbA1c 24 weeks after starting insulin icodec	—

Secondary

Measure	Time frame
The proportion of supplemental insulin in the total insulin dose. Additionally, changes in fasting blood glucose levels, body weight, BMI, treatment adherence, DTSQ scores, DTR-QOL scores, and supplemental insulin dose before starting Insulin Icodec and at 4, 12, and 24 weeks after initiation.	—

Countries

Japan

Contacts

Public ContactKota Takuma

Toho University Omori Medical Center Diabetes, Metabolism and Endocrinology Center

kota.takuma@med.toho-u.ac.jp03-3762-4151

Outcome results