UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes.
Acronym	Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes.
Scientific Title	Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes.
Scientific Title:Acronym	Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes.
Region	Japan

Condition
Condition	Type 1 and type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects between Humalog and ultra rapid lispro(URLi), Fiasp on postprandial blood glucose and daily blood glucose profile.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the effects between Humalog and URLi, Fiasp by measuring blood glucose 10 times a day and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast.
Key secondary outcomes	(1) Daily blood glucose fluctuation by AUC (trapezoidal method) of each insulin by CGM (Continuous Blood Glucose Monitoring Device) (2) Evaluation of endogenous insulin secretion by blood sampling of C-peptide 10 times a day (conducted only for type 2 diabetic patients) (3) Number of occurrences of hypoglycemia (4) Changes in mean blood glucose level on CGM (5) Changes in blood glucose SDlog on CGM (6) Comparison of the effects between URLi and Fiasp by measuring blood glucose 10 times a day and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast. (7) Comparison of the effects between URLi and Fiasp by CGM and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast.

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	This study is an open-label, crossover study. By allocation, Fiasp or URLi will be administered before each meal on the 1st and 2nd days, and Humalog will be administered on the 3rd day. Blood is collected 10 times on each administration day (before breakfast, 30 minutes after breakfast, 60 minutes, 120 minutes, 180 minutes, before lunch, 120 minutes after lunch, before dinner, 120 minutes after dinner, 23:00). Postprandial blood glucose / blood glucose daily variation (AUC) will be compared on the day of administration of URLi and the day of administration of Humalog. The insulin dose under study will not be changed.
Interventions/Control_2	This study is an open-label, crossover study. By allocation, Fiasp or URLi will be administered before each meal on the 1st and 2nd days, and Humalog will be administered on the 3rd day. Blood is collected 10 times on each administration day (before breakfast, 30 minutes after breakfast, 60 minutes, 120 minutes, 180 minutes, before lunch, 120 minutes after lunch, before dinner, 120 minutes after dinner, 23:00). Postprandial blood glucose / blood glucose daily variation (AUC) will be compared on the day of administration of Fiasp and the day of administration of Humalog. The insulin dose under study will not be changed.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	For patients who meet all of the following criteria 1) Age: Type 1 and type 2 diabetic patients whose age at the time of consent is 20 to 75 years old 2) Gender: No matter 3) Patients admitted to our hospital 4) Patients who have been hospitalized for more than 1 week and whose blood glucose level is stable and reproducible using rapid-acting insulin 3 times a day
Key exclusion criteria	Patients who fall under any of the following will not be included in this study. 1) Patients with severe ketosis, diabetic coma or precoma 2) Patients with severe infections, before and after surgery, and with serious external injury 3) Patients with severe renal dysfunction or end-stage renal disease on dialysis 4) Patients judged by the attending physician to be inappropriate for this study due to other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Tsuriya
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 handayama higashi-ku Hamamatsu city
TEL	053-435-2263
Email	dtsuri@hama-med.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Tsuriya
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 handayama higashi-ku Hamamatsu city
TEL	053-435-2263
Homepage URL
Email	dtsuri@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Second Division, Department of Internal Medicine,Hamamatsu University School of Medicine
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	Clinical Research Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 handayama higashi-ku Hamamatsu city
Tel	053-435-2680
Email	rinri@hama-med.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	浜松医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 07 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	Preinitiation
Date of protocol fixation	2020 Year 08 Month 18 Day
Date of IRB	2020 Year 09 Month 01 Day
Anticipated trial start date	2020 Year 10 Month 12 Day
Last follow-up date	2023 Year 07 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	2020 Year 10 Month 07 Day
Last modified on	2020 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047953