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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047953


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name