type 2 diabetes
Conditions
Interventions
Gla300-Deg
Deg-Gla300
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 the start of the study and have been treated with oral hypoglycemic drugs and/or long-acting insulin (excluding Gla300 and Deg) for more than 6 months before screening 2. Patients of glycated hemoglobin (HbA1c) levels 7.0% or more and less than 11.0%
Exclusion criteria
Exclusion criteria: 1. Patients with a history of severe ketosis, diabetic coma or precoma within 6 weeks 2. Patients who developed severe hypoglycemia (diabetic coma or precoma, convulsions requiring third party assistance) within 6 weeks 3. Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine level above 2.0mg/dL) or endstage renal failure patients 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 severe gastrointestinal tract surgery 6. Pregnant women or women who may be pregnant and breastfeeding patients 7. Patients with severe infections, before and after surgery, and severe trauma 8. Patients receiving systemic corticosteroids 9. Patients with severe liver dysfunction (AST or ALT higher than 100U/l) 10. Patients with a history of allergies to the drug to be used for research 11. Patients with malignant tumor or history of malignant tumor 12. Other patients judged by the investigator as inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between blood glucose level, serum albumin level and free fatty acid in BOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Time range of blood glucose level less than 70mg/dl (hypoglycemic range), blood glucose level 180mg/dl or higher (hyperglycemic range), blood glucose level 70-179mg/dl (normal range), blood glucose level less than 54 mg/dl (severe hypoglycemia range), nocturnal hypoglycemia (0: 00-5: 59, less than 70 mg / dl) in 3 days FGM, severe hypoglycemia (diabetic coma or pre-coma, convulsions requiring third-party assistance), mean blood glucose level, standard deviation value, coefficient of variation value, daily fluctuation, M value, mean amplitude of glycemic excursions, changes in the dose of insulin | — |
Countries
Japan
Contacts
Public ContactYuji Kawaguchi
Minami Osaka Hospital Internal medicine
Outcome results
None listed