T2 diabetes
Conditions
Interventions
Start insulin therapy. Subjects that meet "
the insulin treatment withdrawal criteria"
during a follow-up period finish insulin and start DPP-4 inhibitor. An intervention period is until it meets the omission standard after change to DPP-4 inhibitor or from an intervention start to 72
during a follow-up period continue insulin therapy.An intervention period is from start to 72 weeks.
Sponsors
Division of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes untreated in HbA1c 9.0% or more, HbA1c 8.0% or more despite in diabetes drug use, who needs insulin introduction. And, admitted to Devision of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School hospital. (Who have to do basal bolus therapy and self-monitoring of blood glucose.)
Exclusion criteria
Exclusion criteria: A)Under 20 years old B)treatment insulin C)Under insulin treatment within 12 months D)Diabetic coma E)Dysautonomia F)Unconscious hypoglycemia G)Advanced retinopathy (preproliferative diabetic retinopathy / preproliferative diabetic retinopathy) H)Renal dysfunction (eGFR<30mL/min) I)Infection J)During treatment or treatment plan of malignant neoplasm K)Autoimmune disease L)Use of Steroid medicine and/or immunosuppressor M)Active liver disease (ALT or AST >100IU/L or total bilirubin level >2.5 mg/dL) N)Pregnant, possibility of pregnancy, nursing or hope to become pregnant during the study period O)In addition, principal investigator or researcher deems inappropriate as a target
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change of insulin secretory capacity | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Correlation between change of insulin secretory capacity and clinical background 3. The items related to insulin therapy 2-1.The ratio of subjects leaving insulin therapy 2-2.Period until leaving insulin therapy 2-3.Insulin dose in subjects continuing insulin 2-4.Frequency of hypoglycemia and change of body weight in subjects with insulin 4. Examination item only for subjects leaving insulin therapy | — |
Countries
Japan
Contacts
Public ContactMasashi Shimoda
Kawasaki Medical School Division of Diabetes, Endocrinology and Metabolism
Outcome results
None listed