UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042039 |
|---|---|
| Receipt number | R000047953 |
| Scientific Title | Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes. |
| Date of disclosure of the study information | 2020/10/07 |
| Last modified on | 2020/10/07 16:06:57 |
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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
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
dtsuri@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047953
