Unique ID issued by UMIN | UMIN000010474 |
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Receipt number | R000012243 |
Scientific Title | Effect of Insulin Degludec versus twice-daily administration of basal insulin in type 1 diabetes assessed by continuous glucose monitoring system |
Date of disclosure of the study information | 2013/04/15 |
Last modified on | 2014/05/16 12:39:45 |
Effect of Insulin Degludec versus twice-daily administration of basal insulin in type 1 diabetes assessed by continuous glucose monitoring system
JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 2
Effect of Insulin Degludec versus twice-daily administration of basal insulin in type 1 diabetes assessed by continuous glucose monitoring system
JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 2
Japan |
twice-daily administration of basal insulin in type 1 diabetes
Endocrinology and Metabolism |
Others
NO
To compare insulin degludec with insulin glargine or insulin detemir for efficacy and safety in type 1 diabetic patients with twice-daily administration of basal insulin
Safety,Efficacy
Change of HbA1c level of the two treatment
The difference between treatments in following parameters: fasting plasma glucose (FPG), variability (standard deviation) and intra individual variability of 7-point capillary blood glucose profile value measured by SMBG, variability of the two treatments by the continuous glucose monitoring system(Medtronic), frequency and severity of hypoglycemic episodes
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
twice-daily administration of basal insulin is replaced to insulin degludec in type 1 diabetes
20 | years-old | <= |
80 | years-old | >= |
Male and Female
(1)subjcets whose age are more than 20 years and under 80 years.
(2)no restriction on gender
(3)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 serious liver,renal,pituitary and adrenal insufficiency.
3.Patients with diarrhea, vomiting and other gastrointestinal problems.
4.Patients with starvation state or unstable appetite.
5.Patients with serious diabetic complications including proliferative retinopathy.
6.Patients who are pregnant, hope to be pregnant, or are in lactation period.
7.Judged as ineligible by clinical investigators
8.Patients with type 1 diabetes
24
1st name | |
Middle name | |
Last name | Fuki Ikeda |
Juntendo University Graduate School of Medicine
Dept. of Metabolism and Endocrinology
2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
03-3813-3111
fuki@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Fuki Ikeda |
Juntendo University Graduate School of Medicine
Dept. of Metabolism and Endocrinology
2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
03-3813-3111
fuki@juntendo.ac.jp
Juntendo University Graduate School of Medicine
none
Self funding
NO
2013 | Year | 04 | Month | 15 | Day |
Unpublished
Completed
2013 | Year | 03 | Month | 22 | Day |
2013 | Year | 04 | Month | 15 | Day |
2013 | Year | 04 | Month | 12 | Day |
2014 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012243
Research Plan | |
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2018/02/05 | 資料1 臨床研究実施計画書.doc |
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