Type 2 Diabetes
Conditions
Interventions
Switching from existing basal insulin therapy to insulin icodec, a weekly subcutaneous basal insulin analogue.
Sponsors
Amami Central Hospital Department of Diabetes Akiko Tsuchiya
Eligibility
Sex/Gender
All
Inclusion criteria
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%.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline at 24 weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be checked at baseline, 12 weeks, and 24 weeks. 1.Glycemic evaluation parameters: HbA1c (except at 24 weeks), fasting blood glucose level by SMBG (Self-Monitoring of Blood Glucose) 2.Other major laboratory parameters: ALT, AST, gamma-GTP, T-CHO, HDL-C, TG, FwLDL-C, Cre, eGFR, UA, serum albumin, urinary albumin, hemoglobin 3.Body weight, BMI 4.Blood pressure, pulse rate 5.Frequency of hypoglycemia (assessed by medical interview) 6.Occurrence of adverse events 7.Questionnaire to evaluate caregiver satisfaction (STCD2-J) In addition to the above, the glycemic profiles during the initial phase and at 24 weeks post-initiation will be observed using CGM (Continuous Glucose Monitoring), with a particular focus on confirming the occurrence of hypoglycemia (including Time Below Range [TBR] values). Furthermore, an exploratory analysis of factors associated with hypoglycemia will be conducted. | — |
Countries
Japan
Contacts
Public ContactManabu Saito
Toho University Omori Medical Center Diabetes, Metabolism and Endocrinology Center
Outcome results
None listed