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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027368
Receipt No. 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

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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
Email 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
Email souichi19811225@yahoo.co.jp

Sponsor
Institute General Inuyamachuo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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