Unique ID issued by UMIN | UMIN000010885 |
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Receipt number | R000012730 |
Scientific Title | Investigation of efficacy and safety of basal supported oral therapy by alternate-day insulin degludec injection |
Date of disclosure of the study information | 2013/06/05 |
Last modified on | 2015/05/25 12:28:12 |
Investigation of efficacy and safety of basal supported oral therapy by alternate-day insulin degludec injection
JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 3
Investigation of efficacy and safety of basal supported oral therapy by alternate-day insulin degludec injection
JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 3
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
We compare daily insulin degludec injection with alternate-day injection in diabetic patients starting BOT and investigate the efficacy and safety of alternate-day injection.
Efficacy
Changes of HbA1c and fasting glucose levels from baseline
Daily glucose profile by SMBG
Frequency and severity of hypoglycemia and other adverse events
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Intervention group:injection of insulin every other day
Control group:injection of insulin degludec every day
20 | years-old | <= |
90 | years-old | > |
Male and Female
1)subjects with HbA1c(NGSP) 7.4 and more despite the treatment by medications
2)subjcets whose age are more than 20 years
3)no restriction on gender
4)written informed consent was obtained from all subjects after they had been provided with sufficient information
about the study.
1)Patients with past medical history of hypersensitivity to Degludec
2)Patients with hypoglycemia
3)Patients with serious liver,renal,
pituitary and adrenal insufficiency.
Patients with diarrhea, vomiting and
other gastrointestinal problems.
Patients with starvation state or
unstable appetite.
4)Patients with serious diabetic complications including proliferative retinopathy (except for stable condition by photocoagulation).
5)Patients who are pregnant, hope to be pregnant, or are in lactation period.
6)Judged as ineligible by clinical investigators
40
1st name | |
Middle name | |
Last name | Akio Kanazawa |
Juntendo University Graduate School of Medicine
Dept. of Metabolism and Endocrinology
2-1-1 Hongo Bunkyo-ku, Tokyo
1st name | |
Middle name | |
Last name |
Juntendo University Graduate School of Medicine
Dept. of Metabolism and Endocrinology
2-1-1 Hongo Bunkyo-ku, Tokyo
Juntendo University Graduate School of Medicine
none
Self funding
NO
2013 | Year | 06 | Month | 05 | Day |
Unpublished
Terminated
2013 | Year | 05 | Month | 24 | Day |
2013 | Year | 06 | Month | 06 | Day |
2013 | Year | 06 | Month | 05 | Day |
2015 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012730
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