Tokyo, Aug. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058702) titled 'Effects of antidiabetic drugs on endogenous insulin secretion in non-insulin-dependent type 1 diabetes mellitus' on Aug. 6.
Study Type:
Others,meta-analysis etc
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study will identify a population of people who were initially diagnosed with type 2 diabetes and later re-diagnosed with type 1 diabetes, a group presumed to include individuals with features of slowly progressive type 1 diabetes (SPIDDM). The impact of diabetes medications on the trajectory of endogenous insulin secretion will then be examined in this cohort using real world data.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - People who were initially diagnosed with type 2 diabetes (ICD-10 code: E12) and treated with antidiabetic drugs, and then diagnosed with type 1 diabetes (ICD-10 code: E10) between 90 days and less than 10 years after their type 2 diabetes diagnosis and in whom treatment with insulin preparations was initiated
Key exclusion criteria - 1.People who developed diabetic ketoacidosis (E101 and E141) or were hospitalized within one month before or after the diagnosis of type 1 diabetes
2.The prescription of both long-acting and rapid-acting or ultra-rapid-acting insulin preparations prior to the diagnosis of type 1 diabetes had already been used.
3.The initiation of SGLT2i treatment followed the diagnosis of type 1 diabetes.
Target Size - 5000
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 05 Month 20 Day
Date of IRB - 2025 Year 07 Month 28 Day
Anticipated trial start date - 2025 Year 07 Month 28 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=R000067117
Disclaimer: Curated by HT Syndication.