UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026780 |
|---|---|
| Receipt number | R000030734 |
| Scientific Title | Comparison of Insulin glargine U-300 vs Insulin degludec using FreeStyle Libre Pro:randomised crossover study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/07/05 13:20:37 |
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Basic information
Public title
Comparison of Insulin glargine U-300 vs Insulin degludec using FreeStyle Libre Pro:randomised crossover study
Acronym
Comparison of Insulin glargine U-300 vs Insulin degludec using FreeStyle Libre Pro:randomised crossover study
Scientific Title
Comparison of Insulin glargine U-300 vs Insulin degludec using FreeStyle Libre Pro:randomised crossover study
Scientific Title:Acronym
Comparison of Insulin glargine U-300 vs Insulin degludec using FreeStyle Libre Pro:randomised crossover study
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the safety and efficacy of insulin glargine U-300 and insulin degludec
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<70mg/dL hypoglycemia
Key secondary outcomes
CV-value
mean glucose level,SD
M-value,MODD,
<54mg/dL hypogliycemia
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
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Type 2 diabetes patients using degludec were assigned to glargin U-300 group and degludec group by the envelope method, each patient was fitted with Libre Pro and targeted to the pre-breakfast blood glucose of 100 mg / dl, the patient self- Titration is done for one week (adjustment period).
Interventions/Control_2
The dose is fixed for the next week and the blood glucose level of Libre Pro is evaluated (evaluation period)
Interventions/Control_3
Preliminary treatment basal insulin is switched to glargine U-300, degludec 1 week before each patient was fitted with Libre Pro and targeted to the pre-breakfast blood glucose of 100 mg / dl, the patient self- Titration is done for one week (adjustment period)
Interventions/Control_4
The dose is fixed for the next week and the blood glucose level of Libre Pro is evaluated (evaluation period)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
40 patients with type 2 diabetes using insulin degludec (excluding patients with additional insulin)
Key exclusion criteria
Severe renal dysfunction
Judged to be unsuitable for participation for medical reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Yamabe |
Organization
Murakami Memorial Hospital
Division name
Department of Diabetes Internal medicine
Zip code
7220014
Address
1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
TEL
0848-22-3131
mk-hp2@able.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Yamabe |
Organization
Murakami Memorial Hospital
Division name
Department of Diabetes Internal medicine
Zip code
7220014
Address
1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
TEL
0848-22-3131
Homepage URL
mk-hp2@able.ocn.ne.jp
Sponsor or person
Institute
Murakami Memorial Hosupital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Murakami Memorial Hospital
Address
1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
Tel
0848223131
mk-hp2@able.ocn.ne.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/journaljdi
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/journaljdi
Number of participants that the trial has enrolled
24
Results
Glucose levels less than 70 mg/dL were not significantly different between the two insulin treatments. Nocturnal hypoglycemia with Gla300 was significantly lower than that with Deg treatment. Incidence of nocturnal hypoglycemia with Deg treatment was associated with the concomitant use of metformin.
Results date posted
| 2020 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 07 | Month | 10 | Day |
Baseline Characteristics
24 Japanese patients with type 2 diabetes
Participant flow
We compared the efficacy and safety of insulin glargine 300 U/mL (Gla300) and insulin degludec U100 (Deg) using a flash glucose monitoring system.
Adverse events
None
Outcome measures
The primary end-points were the mean percentage of time in the target glucose range (70~179 mg/dL) and hypoglycemia (less than 70 mg/dL), as measured using flash glucose monitoring during the last 7 days of each 14-day period
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2020 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030734
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/05 | 3MBAstudy英文.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
