type 2 diabetes insomnia
Conditions
Interventions
The group that oral medication of 8 mg ramelteon tablet once daily before sleep for 6 months
The group that oral medication of 8 mg ramelteon tablet once daily for first 3 months and then withdrawal
Sponsors
Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The insomnic patients with type 2 diabetes who signed the informed consent in this study 2.HbA1c fluctuation is less than 0.5% over the last 3 months 3.HbA1c level is less than 8% over the last 3 months 4.Neither new start nor change of medications for diabetes and insomnia required at least 3 months before and after administration.
Exclusion criteria
Exclusion criteria: 1.Past history of administration for insomnia over the last 3 months 2.Medication for psychiatric disorder 3.severe liver disorder 4.Patients determined to be inappropriate by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1c from baseline to 6 months after administration of ramelteon | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of folowing items from baseline to 6 months after administration of ramelteon 1 glucose metabolism (IRI, sCPR, FPG, GA) 2 PSQI 3 SF-36 4 TC, LDL-C, TG, HDL-C, hsCRP, ferritin 5 blood pressure, body weight 6 adverse event after administration of ramelteon | — |
Countries
Japan
Contacts
Public ContactTetsuji Tsunoda
Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations Department of Endocrinology & Metabolism
Outcome results
None listed