Unique ID issued by UMIN | UMIN000029630 |
---|---|
Receipt number | R000031895 |
Scientific Title | Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300) |
Date of disclosure of the study information | 2017/10/19 |
Last modified on | 2021/10/26 17:21:48 |
Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Japan |
Type 1 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To clarify the difference that two different ultra-long acting insulin affect the fasting blood glucose fluctuation in type 1 diabetic patients who are depleted of endogenous insulin secretion.
Safety,Efficacy
Standard deviation of fasting blood glucose by SMBG
Nocturnal blood glucose fluctuation index by flash glucose monitoring
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Intervention at glargine-U 300
cross over
Intervention at degludec
cross over
20 | years-old | <= |
99 | years-old | > |
Male and Female
1) Type 1 diabetes patients who were confirmed to have CPR of less than 0.2 ng / mL at least twice by a conventional measurement method
2) Long-acting or intermediate insulin injection once a day and MDI of super fast-acting or fast-acting insulin have been treated for more than 1 year
3) SMBG can be implemented
4) FGM can be implemented
1)HbA1c > 9.0%
2)other medication to affect glucose concentarion
3)severe hypertension(Systolic blood pressure of 180 mmHg or more, diastolic blood pressure of 100 mmHg or more)
4)severe liver dysfunction (Increase of AST, ALT more than 2.5 times normal upper limit)
5)severe renal dysfunction (Cr > 2)
6)severe heart failure (NYHA>2)
7)Recent serious hypoglycemia, recent hospitalization due to ketoacidosis
8)retinopathy with high bleeding risk
9)pregnant or breast-feeding women
10)Cancer patient
11)psychological disorder
12) others inappropriate for this study
50
1st name | Sakaguchi |
Middle name | |
Last name | Kazuhiko |
Kobe University Graduate School of Medicine
Division of Diabetes and Endocrinology Department of Internal Medicine
650-0017
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
81-76-382-5861
kzhkskgc@med.kobe-u.ac.jp
1st name | Sakaguchi |
Middle name | |
Last name | Kazuhiko |
Kobe University Graduate School of Medicine
Division of Diabetes and Endocrinology Department of Internal Medicine
650-0017
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
81-76-382-5861
kzhkskgc@med.kobe-u.ac.jp
Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine
no
Other
IRB of Kobe University Hospital
7-5-1, Kusunoiki-Cho, Chuoku, Kobe
078-382-6669
chiken@med.kobe-u.ac.jp
NO
神戸大学医学部附属病院(兵庫県)
2017 | Year | 10 | Month | 19 | Day |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250619/
Published
http://dx.doi.org/10.1111/dom.14161
46
Comparing the SD of FBG level, IDeg was noninferior to IGla-300 in SD of FBG.
2021 | Year | 10 | Month | 26 | Day |
2020 | Year | 08 | Month | 03 | Day |
The participants were individuals with type 1 diabetes whose serum C-peptide immunoreactivity was less than 0.2 ng/mL. 14 male and 32 female participated this study. The age was 53.3 +/- 14.7 years old. The average HbA1c value was 7.6 +/- 0.7 %.
The registration pace was slower than expected. The number of patients registered at each facility was 22 from Kobe University Hospital, accounting for about 50%, while all other facilities had less than 5 patients. There were no patient registrations at three centers. CGM data was insufficient for 14 patients.
During the study period, severe adverse event was not reported.
The primary aim of the study was evaluation of the noninferiority of IDeg relative to IGlarU300 in terms of day-to-day variability of FBG levels as evaluated by the standard deviation (SD) determined from SMBG data.
No
Not applicable
Completed
2017 | Year | 09 | Month | 01 | Day |
2017 | Year | 11 | Month | 29 | Day |
2018 | Year | 06 | Month | 08 | Day |
2019 | Year | 08 | Month | 31 | Day |
2017 | Year | 10 | Month | 19 | Day |
2021 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031895