Type 2 diabetes mellitus
Conditions
Interventions
Oral medication of bazedoxifene(20mg/day). Taking blood and urine samples at 0, 4, 8 and 12 weeks after administration of the bazedoxifene.
Sponsors
Yokohama City University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.The type 2 diabetes patients under 85 years of age with the interval of 2 years after the menopause. 2.HbA1c fluctuation is less than 0.5% for the past 12 weeks. 3.HbA1c level is less than 8.4%(NGSP). 4.Body Mass Index is less than 30. 5.Renal function is more than eGFR 30 ml/min/1.73m2. 6.Neither a new start nor alteration of medication is required for treatment of diabetes during the period from 4 weeks before the start of administration of bazedoxifene to 12 weeks after the administration. 7. Neither a new start nor alteration of medication is required for treatment by use of ACE-I, ARB, Statin, PPI during the period from 4 weeks before the start of administration of bazedoxifene to 12 weeks after the administration. 8.Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Past history of bone fractures related to non-traumatic accident. 2.Current use of pioglitazone (regardless of treatment duration). 3.Current use of steroid hormones (regardless of treatment duration). 4.The patients with the thyroid function abnormality for which treatment is needed. 5.Current use of other medications for osteoporosis: Vitamin D: within 12 weeks after the suspension of administration. Vitamin K2:within 12 weeks after the suspension of administration. Bisphosphonates:within 24 weeks after the suspension of administration. The others SERM(raloxifene):within 24 weeks after the suspension of administration. PTH:within 24 weeks after the suspension of administration. 6.Past history of deep vein thrombosis. 7.Cancer bearing patients. 8.Patients determined to be inappropriate by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes to be shown in levels of serum adiponectin during the period from the start of medication to the last medication after 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes to be shown on glucose metabolism markers, such as FPG, HbA1c (NGSP), IRI, s-CPR during the period from the start of medication to the last medeication after 12 weeks. 2.Changes to be shown on the bone quality markers, such as s-homocysteine, s-pentosidine, and also on the bone metabolism markers, such as TRAP-5b, u-CTX, NTX, osteocalcin, ucOC during the period from the start of medication to the last medeication after 12 weeks. 3.Changes to be shown on biochemical markers, such as TC, LDL-C, TG, HDL-C, hsCRP, ferritin, s-Cr, cystatin C during the period from the start of medication to the last medeication after 12 weeks. 4.Changes to be shown on the PWV during the period from the start of medication to the last medeication after 12 weeks. | — |
Countries
Japan
Contacts
Public ContactYamada Masayo
Yokohama Sakae Kyousai Hospital, Federation of National Public Service Personnel Mutual Associations Department of Endocrinology & Metabolism
Outcome results
None listed