Tokyo, Feb. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060700) titled 'Evaluation of Treatment Efficacy, Including Patient Satisfaction with Once-Weekly Basal Insulin Icodec in Patients with Type 1 and Type 2 Diabetes' on Feb. 20.
Study Type:
Observational
Primary Sponsor:
Institute - Toho University Omori Medical Center
Condition:
Condition - Type 1 and Type 2 Diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study evaluates the efficacy and safety, including quality of life, in clinical practice of switching from daily basal insulin to weekly insulin icodec in patients with type 1 and type 2 diabetes undergoing insulin bolus therapy and continuous glucose monitoring (CGM).
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - About Type 1 Diabetes
1. Patients with type 1 diabetes
2. Patients aged 18 years or older but under 75 years at the start of the study (at the time of ethics committee approval)
3. Patients undergoing treatment with frequent insulin injections
4. Patients with HbA1c <8.0% at the start of the study (at the time of ethics committee approval)
5. Patients capable of consenting to participate in this study and able to understand the consent form and other explanatory documents
About Type 2 Diabetes
1. Patients with Type 2 Diabetes
2. Patients aged 18 years or older at the start of the study (at the time of ethics committee approval)
3. Patients undergoing treatment with frequent insulin injections
4. Patients with HbA1c <10.0% at the start of the study (at the time of ethics committee approval)
5. Patients capable of consenting to participate in this study and able to understand the consent form and other explanatory documents
Key exclusion criteria - About Type 1 Diabetes
Patients meeting any of the following criteria are excluded from this study.
1. Type 2 diabetes
2. Heavy alcohol drinkers (pure alcohol intake of 60g/day or more for men, 30g/day or more for women)
3. Patients with dementia
4. Pregnant women, women who may be pregnant, women who wish to become pregnant, and breastfeeding women
5. Patients whose primary physician determines they have poor adherence
6. Other patients deemed unsuitable for participation in this study by the responsible physician
About Type 2 Diabetes
Patients meeting any of the following criteria are excluded from this study.
1. Type 1 diabetes
2. Heavy alcohol drinkers (pure alcohol intake of 60g/day or more for men, 30g/day or more for women)
3. Patients with dementia
4. Pregnant women, women who may be pregnant, women who wish to become pregnant, and breastfeeding women
5. Patients deemed to have poor adherence by their primary physician
6. Other patients deemed unsuitable for participation in this study by the responsible physician
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 27 Day
Anticipated trial start date - 2026 Year 02 Month 23 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069429
Disclaimer: Curated by HT Syndication.
