UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027368 |
|---|---|
| Receipt number | R000031366 |
| Scientific Title | Which is the best ultra-rapid acting insulin to improve postprandial glycemic variability? Comparison of insulin glulisine vs. insulin lispro vs. insulin aspart using FreeStyle Libre Pro: randomised triple crossover study |
| Date of disclosure of the study information | 2017/05/17 |
| Last modified on | 2019/08/27 09:04:12 |
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Basic information
Public title
Which is the best ultra-rapid acting insulin to improve postprandial glycemic variability? Comparison of insulin glulisine vs. insulin lispro vs. insulin aspart using FreeStyle Libre Pro: randomised triple crossover study
Acronym
Comparison of insulin glulisine vs. insulin lispro vs. insulin aspart using FreeStyle Libre Pro: randomised triple crossover study
Scientific Title
Which is the best ultra-rapid acting insulin to improve postprandial glycemic variability? Comparison of insulin glulisine vs. insulin lispro vs. insulin aspart using FreeStyle Libre Pro: randomised triple crossover study
Scientific Title:Acronym
Comparison of insulin glulisine vs. insulin lispro vs. insulin aspart using FreeStyle Libre Pro: randomised triple crossover study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate which is the best ultra-rapid acting insulin to improve postprandial glycemic variability, insulin glulisine, insulin lispro or insulin aspart.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
08:00 to 24:00 percentage of time in target range (70~140 mg/dL)
Key secondary outcomes
08:00 to 24:00 mean absolute glucose (MAG)
08:00 to 24:00 glycemic variability percentage (GVP)
08:00 to 24:00 mean glucose level
08:00 to 24:00 standard deviation (SD)
08:00 to 24:00 coefficient of variation (CV)
Highest postprandial glucose level within 3 hours after each meal
Differences between preprandial and highest postprandial glucose level for each meal
Post-breakfast glucose gradient
AOC (<70 mg/dL) for glycemic variability (0:00~8:00, 8:00~12:00, 12:00~18:00, 18:00~24:00)
M-value (8:00~24:00,24h)
MAGE
ADRR
Time from start of meal to the highest postprandial glucose level
MODD
08:00 to 24:00 low blood glucose index (LBGI)
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FreeStyle Libre Pro is worn after admission. insulin glulisine are evaluated on day 3 and day 4. Then, insulin lispro are evaluated on day 8 and day 9. Then, insulin aspart are evaluated on day 13 and day 14.
Interventions/Control_2
FreeStyle Libre Pro is worn after admission. insulin aspart are evaluated on day 3 and day 4. Then, insulin glulisine are evaluated on day 8 and day 9. Then, insulin lispro are evaluated on day 13 and day 14.
Interventions/Control_3
FreeStyle Libre Pro is worn after admission. insulin lispro are evaluated on day 3 and day 4. Then, insulin aspart are evaluated on day 8 and day 9. Then, insulin glulisine are evaluated on day 13 and day 14.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients medicated with basal+bolus therapy (insulin glulisine+ insulin glargine 300 U/ml) for 3 month or longer
Key exclusion criteria
Patients with severe renal dysfunction (serum creatinine level more than 2.0 mg/dL)
Patients who were aware that they were hypoglycemic and took glucose tablets
Patients considered not suitable for participation due to medical reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyamachuo Hospital
Division name
Department of Diabetes
Zip code
Address
6, futakozuka, goroumaru, Inuyama-city, Aichi
TEL
0568-62-8111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyamachuo Hospital
Division name
Department of Diabetes
Zip code
Address
6, futakozuka, goroumaru, Inuyama-city, Aichi
TEL
0568-62-8111
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
General Inuyamachuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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 | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 17 | Day |
Last modified on
| 2019 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031366
