Type 2 diabetes
Conditions
Interventions
GLP-1 first therapy Liraglutide (6 months)
Insulin GLP-1 relay therapy Insulin degludec from baseline to 3 month (3 months) Liraglutide from 4 to 6 month (3 months)
Sponsors
Kanazawa university Department of Disease Control and Homeostasis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes with HbA1c above 8% No limitation in sex and in or out-patients.
Exclusion criteria
Exclusion criteria: Patients who have history of serious hypersensitivity to Liraglutide, Exenatide, Lixisenatide and insulin degludec. Patients with type 1 diabetes or impaired glucose tolerance due to other specific mechanisms or diseases or gestational diabetes. Patients with diabetic ketoacidosis Patients who have history of severe hypoglycemia with coma or loss of consciousness Patients with serious infection or severe traumatic injury Patients with steroids as unstable daily dose. Patients with unstable hypertension with medication like systolic blood pressure above 160 mmHg or diastolic blood pressure above 100mmHg. Patients with severe hepatic failure or renal failure or cardiac disorder and identified inappropriate patients for this study by the physicians in charge. Patients with proliferative retinopathy (excluding old proliferative retinopathy without necessary of intervention) and patients with maculopathy with necessary of intervention. Patients who have history of malignancy Excluding following patients Patients who have history of cured basal cell tumor by appropriate treatment or uterocervical carcinoma in situ Patients who have history of malignancy more than 1 year before and also have no reappearance Patients who onset malignancy during the period of the study. Patients with severe complication and identified inappropriate patients for this study by the physicians in charge. The pregnant women or women having possibilities of being pregnant and the women with breast-feeding Other patients who are identified inappropriate patients for this study by the physicians in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose control by change in FPG, 1,5-AG and HbA1c. Achievement rate of HbA1c goals below 7%. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in physical findings by change of body weight, adipose mass, basal metabolism and waist circumference 2 Change in biochemical finding 3 Change in lipid metabolism (TC, HDL-C, TG) Change in hepatic and renal function 4 Identification of predictors for improvement of glucose control 5 Upper limit of daily insulin dose which can be changed from insulin therapy to GLP-1 therapy 6 Adverse events 7 Change in hepatokine | — |
Countries
Japan
Contacts
Public ContactToshinari Takamura
Kanazawa university Department of Disease Control and Homeostasis
Outcome results
None listed