Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058383) titled 'Efficacy and safety of weekly basal insulin icodec in elderly type 2 diabetes patients with insufficient self-management of insulin therapy' on July 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Amami Central Hospital Department of Diabetes Akiko Tsuchiya

Condition: Condition - Type 2 Diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate the efficacy and safety of once-weekly basal insulin icodec under real-world clinical conditions in elderly patients with type 2 diabetes who have insufficient self-management of their insulin therapy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Switching from existing basal insulin therapy to insulin icodec, a weekly subcutaneous basal insulin analogue.

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Outpatients with type 2 diabetes at Amami Central Hospital. 2.Patients who have difficulty with self-management of their treatment and require assistance from family or home-visit nursing care. 3.Patients aged 65 years or older (based on age at the date of consent). 4.Patients who, or whose family members, have the capacity to consent to participate in the study and are able to understand the informed consent form and other explanatory documents. 5.Patients who have been treated with once-daily basal insulin for the past three months and have not used any other types of insulin. 6.Patients with a baseline HbA1c of 6.5% or higher and less than 10.0%. Key exclusion criteria - Patients who meet any of the following criteria will be excluded from the study:

1.Patients with type 1 diabetes. 2.Patients with severe liver disease, or those with AST (GOT) or ALT (GPT) levels of 100 IU/L or higher. 3.Patients with severe renal disease, or those with a serum creatinine level of 2.0 mg/dL or higher. 4.Patients with manifest heart failure or those who have had a myocardial infarction within 3 months prior to the study start. 5.Patients with severe pancreatic disease. 6.Patients with acute or severe medical conditions that may affect glycemic control. 7.Patients with severe infections, severe trauma, or those in the perioperative period. 8.Patients with severe chronic intestinal diseases such as inflammatory bowel disease, colonic ulcer, localized intestinal obstruction, predisposition to intestinal obstruction, or conditions associated with digestive/absorptive abnormalities. 9.Habitual heavy alcohol drinkers (e.g., an average daily consumption of more than 3 'go' of sake, 3 large bottles of beer, 3 double whiskies, 6 glasses of wine, or 2 'go' of shochu). 10.Patients with a baseline BMI of 30 kg/m2 or higher. 11.Patients with a baseline basal insulin dose exceeding 30 units/day. 12.Patients who experience one or more episodes of hypoglycemia per week during the baseline period. 13.Other patients deemed unsuitable for the study by the investigator. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 23 Day Date of IRB - 2025 Year 06 Month 23 Day Anticipated trial start date - 2025 Year 06 Month 25 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066723

Disclaimer: Curated by HT Syndication.