Tokyo, June 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061951) titled 'The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections' on June 18.
Study Type:
Observational
Primary Sponsor:
Institute - Toho University Omori Medical Center
Condition:
Condition - Type 2 diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to gain new insights for future diabetes care by evaluating glycemic control, adherence, and insulin dosage in patients with type 2 diabetes currently receiving intensive insulin therapy, using once-weekly insulin icodec.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key 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
Key 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
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 06 Month 09 Day
Date of IRB - 2026 Year 06 Month 09 Day
Anticipated trial start date - 2026 Year 06 Month 22 Day
Last follow-up date - 2027 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070804
Disclaimer: Curated by HT Syndication.
