type 2 diabetes
Conditions
Interventions
long-acting insulin analogues including ultra-long acting insulin analogue and oral hypoglycemic agents
Sponsors
The jikei University School of Medicine
Tokyo Wemen'
s medical University Yachiyo medical center, Tokyo Dental College Ichikawa, Asahi central hospital, Japanese Red Cross Narita, and Funabashi Municipal Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes who are older than 65 y.o., and have been already receiving diet therapy and/or oral agents for more than 3 months, but not receiving any insulin therapy. The patients' HbA1c (NGSP) should be more than 7.9 % for at least the recent two months. 2. Introduce once-daily therapy with long-acting insulin analogue. Oral hypoglycemic agents may be added to the therapy.
Exclusion criteria
Exclusion criteria: Patients who are ketosis-prone, have advanced renal failure or nephritic syndrome, proliferative retinopathy, severe cardiac disease, liver damage, and also who have active malignancies with poor prognosis. Patients who are impossible to do the self-injection therapy nor answer to the DTQS by themselves. Patients whom the doctors would judge as inappropriate for the inclusion should also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose-lowering effect to the target level and QOL satisfaction in elderly patients without any severe problem in management of diabetesby one-daily long acting insulin and once-daily oral agents | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of laboratory data including HbA1c, 1,5-AG and FPG, of frequency of hypoglycemia during the trial, and of the QOL score (Diabetes Treatment Satisfaction Questionnaire:DTSQ). | — |
Countries
Japan
Contacts
Public ContactKenji Yamashiro
The Jikei University Kashiwa Hospital Division of Diabetes, Metabolism and Endocrinology
Outcome results
None listed