type 2 diabetes
Conditions
Interventions
Switching IDegLira after IDegAsp prior treatment
Switching IDegAsp after IDegLira prior treatment
Sponsors
Minami Osaka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who have been diagnosed with type 2 diabetes for more than 1 year before this study and have been treated with oral hypoglycemic drugs and/or long-acting insulin (excluding IDegAsp and IDegLira) for at least 6 months before screening. 2.Patients with glycated hemoglobin (HbA1c) levels of 7.0% or more and less than 11.0%.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of severe ketosis, diabetic coma or previous coma within 6 weeks of this study. 2.Patients with a history of severe hypoglycemia (diabetic coma or pre-coma and convulsions needing third person assistance) within 6 weeks of this study. 3.Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine 2.0mg/dL and more) or end-stage renal failure on dialysis. 4.Patients with proliferative retinopathy (however, patients who have undergone photocoagulation and have stable symptoms can be included). 5.Patients with a history of surgery for severe gastrointestinal disease. 6.Pregnant or possibly pregnant and lactating patients. 7.Patients with severe infections, before and after surgery, with severe trauma. 8.Patients receiving systemic corticosteroids. 9.Patients with severe liver dysfunction (high AST or ALT 100 U/L and more). 10.Patients with a history of allergy to the drug to be used in this study. 11.Patients with malignancy or a history of malignancy. 12.Patients judged by the investigator to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time of 3-day blood glucose 70-180 mg/dl (within target range), blood glucose 60 minutes, 90 minutes, and 120 minutes after each meal by using Flash Glucose Monitoring (FGM) for each treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of time of 3-day blood glucose level less than 70 mg/dl (below target range), blood glucose level above 180 mg/dl (above target range), blood glucose level less than 54 mg/dl (severe hypoglycemic range), blood glucose level less than 70 mg/dl during night (0:00-6:00), The frequency of severe hypoglycemia (requiring the assistance of a third person, such as diabetic coma or precoma, convulsions), average blood glucose level, standard deviation value, coefficient of variation value, day to day variation, M-value, mean amplitude of glycemic excursions, C-peptide index pre and post-treatment, fasting blood glucose in early morning, Insulin degludec dose in each insulin-containing injection | — |
Countries
Japan
Contacts
Public ContactYuji Kawaguchi
Minami Osaka Hospital Internal medicine
Outcome results
None listed