type 2 diabetes
Conditions
Interventions
administration of svorexant
don'
t administretion of svorexant
Sponsors
Toho University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Type 2 diabetes patients controlled inadequately with HbA1c 6.0 to 9.9 and changed within 1 (2)Patient received drug medical treatment in addition to diet and exercise therapy for 12 weeks or more (3)Adults who are 20 years or older and 80 years or younger (4)Patients diagnosed having a sleep disorder by Pittsuburgh score 6 points or more (5)Patients do not take a sleeping drugs or antipsychotic within one year (6)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 taking a sleeping drugs or antipsychotic within one year. (3) Patients who had myocardial infarction within 3 months, or obvious heart failure case (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 with severe diabetic neuropathy (9) Patients having a proliferative retinopathy (10) Patients with a serious infectious disease or a serious injury (11) Excessive common custom drinker (12) A pregnant woman or the woman who may be pregnant (13) In addition, the patients who will be judged inappropriate by an attendant physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes of validation by continuas glcose monitor (CGM) 16 weeks later. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)changes of quality of life(QOL),questionnaire about the sleep,and dietary intake 16 weeks later. (2)a reduction degree of HbA1c,GA and fasting blood prasma glucose 16 weeks later. (3)a reduction degree of lipid parameters(HDL cholesterol,LDL cholesterol,triglyceride)and albumin in urine 16 weeks later. (4)changes of blood or urine hormone level 16 weeks later. (5)changes of body weight,blood pressure,abdominal circumscription,and body composition 16 weeks later. | — |
Countries
Japan
Contacts
Public ContactTakahisa Hirose
Toho University School of Medicine Divsion of diabetes, metabolism and endocrinology
Outcome results
None listed