diabetes
Conditions
Interventions
Insulin intensive therapy (insulin aspart,insulin glargine BS) Diet therapy(28kcal/kg)
Insulin intensive therapy (insulin aspart,insulin glargine BS) Diet therapy(28kcal/kg) Drug therapy Canagl
Sponsors
Toho University School of Medicine Division of diabetes,metabolism and endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Insulin independent Type 2 diabetes patients controlled inadequately with HbA1c more than 8.0% 2. Patients who does not use human GLP-1 analog or insulin or SGLT2 inhibitor 3. Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes mellitus patients or secondary diabetic mellitus 2.Patients who had myocardial infarction within 3 months,or obvious heart failure case 3.Patients who had the past hypersensitivity for the used drug 4.Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma 5.Patients with severe liver disease 6.Patients with severe renal disease 7.Patients with severe pancreas disease 8.Patients during cancer treatment 9.Patients with hemoglobin (Hb) less than 11g/dL 10.Patients that the number of the platelets is less than 100,000 /mm3 11.Patients with severe diabetic neuropathy 12.Patients having a proliferative retinopathy 13.Patients with a serious infectious disease or during a surgery period or a serious injury 14.Excessive common custom drinker 15.A pregnant woman or the woman who may be pregnant 16.In addition, the patients who will be judged inappropriate by an attendant physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| respiratory quotient and energy consumption of meal tolerance test by indirect calorimetry (pre research period,post 7days, 12weeks at the research period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. total insulin use and period until normal blood glucose response (fasting blood glucose less than 110mg/dl,average plasma glucose less than 126mg/dl) 2. index of blood glucose control: change of casual blood glucose by self monitoring blood glucose during research period 3. index of blood ketone body:casual beta-Hydroxybutyric acid measured by beta-ketone body measuring-instrument and total ketone body measured by clinical test during research period 4. changes of body weight,blood pressure, and body mass index during research period 5. change of urine volume,urination frequency, urinary glucose per day during research period 6. an index of lipid parameters(total cholesterol,triglyceride,HDL cholesterol, LDL cholesterol)(pre research period, post 7days,4weeks,8weeks,12weeks at the research period) 7. pancreas beta cell function:plasma CPR etc.(pre research period,post 7days, 12weeks at the research period) 8. degree of satisfaction of treatment: questionnaire with Diabetes Therapy-Related QOL (DTR-QOL) (pre research period,post 12weeks at the research period) 9.neurological evaluation of energy metabolism of meal tolerance test (pre research period,post 12weeks at the research period) 10. evaluation of safety:Symptoms of hypoglycemia or hyperglycemia,digestive or other harmful phenomenon,abnormal data of clinical exam during research period 11.change of plasma marker of energy metabolism, various carbonic acid concentration and body composition (pre research period,post 7days, 12weeks at the research period) 12.evaluation of compliance of nutritional intake by BDHQ (pre research period,post 4weeks,12 weeks at the research period) 13.evaluate changes of blood glucose,the marker of carbohydrate and lipid metabolism,during meal tolerance test. (pre research period,post 7days,12 weeks at the research period) | — |
Countries
Japan
Contacts
Public ContactHiroyuki Igarashi
Toho University School of Medicine Division of diabetes,metabolism and endocrinology
Outcome results
None listed