UMIN-CTR Clinical Trial

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