Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060405) titled 'Exploration of an Outpatient Initiation and Titration Algorithm for Insulin Icodec in Japanese Patients with Type 2 Diabetes' on Jan. 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Kansai Rousai Hospital

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

Objective: Narrative objectives1 - To Evaluate the Efficacy and Safety of a Body Weight Based Initiation and Glycemia Guided Titration Protocol Using Long-Acting Insulin Icodec in the Treatment of Type 2 Diabetes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Insulin icodec is initiated at a dose of 1 unit/kg and titrated every two weeks according to the protocol, based on pre-breakfast blood glucose levels. The pre-breakfast blood glucose value is defined as the average of the measurements obtained on the day of insulin adjustment and the preceding day.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients who are able to provide written informed consent to participate in the study of their own free will. 2) Patients who meet the diagnostic criteria for type 2 diabetes mellitus. 3) Patients aged 20 years or older at the time informed consent is obtained. 4) Patients for whom insulin dose adjustment every two weeks after intervention is feasible. Key exclusion criteria - 1) Patients with contraindications to insulin icodec used in this study. 2) Patients with active malignancy. 3) Patients with severe hepatic or renal impairment that may affect the safety evaluation of the study drug. 4) Women who are pregnant or may be pregnant. 5) Breastfeeding women. 6) Patients receiving treatment with oral systemic corticosteroids. 7) Patients deemed ineligible by the principal investigator or sub-investigators for any other reason. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 26 Day Anticipated trial start date - 2026 Year 01 Month 26 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069095

Disclaimer: Curated by HT Syndication.