UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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)
Acronym
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)
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)
Scientific Title:Acronym
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)
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standard deviation of fasting blood glucose by SMBG
Key secondary outcomes
Nocturnal blood glucose fluctuation index by flash glucose monitoring
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention at glargine-U 300
cross over
Interventions/Control_2
Intervention at degludec
cross over
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sakaguchi |
| Middle name | |
| Last name | Kazuhiko |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
81-76-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakaguchi |
| Middle name | |
| Last name | Kazuhiko |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
81-76-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kobe University Hospital
Address
7-5-1, Kusunoiki-Cho, Chuoku, Kobe
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250619/
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1111/dom.14161
Number of participants that the trial has enrolled
46
Results
Comparing the SD of FBG level, IDeg was noninferior to IGla-300 in SD of FBG.
Results date posted
| 2021 | Year | 10 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 03 | Day |
Baseline Characteristics
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 %.
Participant flow
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.
Adverse events
During the study period, severe adverse event was not reported.
Outcome measures
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.
Plan to share IPD
No
IPD sharing Plan description
Not applicable
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031895
