UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029630
Receipt number R000031895
Scientific Title Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Date of disclosure of the study information 2017/10/19
Last modified on 2021/10/26 17:21:48

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Basic information

Public title

Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)

Acronym

Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)

Scientific Title

Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)

Scientific Title:Acronym

Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)

Region

Japan


Condition

Condition

Type 1 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the difference that two different ultra-long acting insulin affect the fasting blood glucose fluctuation in type 1 diabetic patients who are depleted of endogenous insulin secretion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Standard deviation of fasting blood glucose by SMBG

Key secondary outcomes

Nocturnal blood glucose fluctuation index by flash glucose monitoring


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

Intervention at glargine-U 300
cross over

Interventions/Control_2

Intervention at degludec
cross over

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

99 years-old >

Gender

Male and Female

Key inclusion criteria

1) Type 1 diabetes patients who were confirmed to have CPR of less than 0.2 ng / mL at least twice by a conventional measurement method
2) Long-acting or intermediate insulin injection once a day and MDI of super fast-acting or fast-acting insulin have been treated for more than 1 year
3) SMBG can be implemented
4) FGM can be implemented

Key exclusion criteria

1)HbA1c > 9.0%
2)other medication to affect glucose concentarion
3)severe hypertension(Systolic blood pressure of 180 mmHg or more, diastolic blood pressure of 100 mmHg or more)
4)severe liver dysfunction (Increase of AST, ALT more than 2.5 times normal upper limit)
5)severe renal dysfunction (Cr > 2)
6)severe heart failure (NYHA>2)
7)Recent serious hypoglycemia, recent hospitalization due to ketoacidosis
8)retinopathy with high bleeding risk
9)pregnant or breast-feeding women
10)Cancer patient
11)psychological disorder
12) others inappropriate for this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Sakaguchi
Middle name
Last name Kazuhiko

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology Department of Internal Medicine

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

81-76-382-5861

Email

kzhkskgc@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Sakaguchi
Middle name
Last name Kazuhiko

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology Department of Internal Medicine

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

81-76-382-5861

Homepage URL


Email

kzhkskgc@med.kobe-u.ac.jp


Sponsor or person

Institute

Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

no

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

IRB of Kobe University Hospital

Address

7-5-1, Kusunoiki-Cho, Chuoku, Kobe

Tel

078-382-6669

Email

chiken@med.kobe-u.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

神戸大学医学部附属病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 19 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250619/

Publication of results

Published


Result

URL related to results and publications

http://dx.doi.org/10.1111/dom.14161

Number of participants that the trial has enrolled

46

Results

Comparing the SD of FBG level, IDeg was noninferior to IGla-300 in SD of FBG.

Results date posted

2021 Year 10 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 08 Month 03 Day

Baseline Characteristics

The participants were individuals with type 1 diabetes whose serum C-peptide immunoreactivity was less than 0.2 ng/mL. 14 male and 32 female participated this study. The age was 53.3 +/- 14.7 years old. The average HbA1c value was 7.6 +/- 0.7 %.

Participant flow

The registration pace was slower than expected. The number of patients registered at each facility was 22 from Kobe University Hospital, accounting for about 50%, while all other facilities had less than 5 patients. There were no patient registrations at three centers. CGM data was insufficient for 14 patients.

Adverse events

During the study period, severe adverse event was not reported.

Outcome measures

The primary aim of the study was evaluation of the noninferiority of IDeg relative to IGlarU300 in terms of day-to-day variability of FBG levels as evaluated by the standard deviation (SD) determined from SMBG data.

Plan to share IPD

No

IPD sharing Plan description

Not applicable


Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 11 Month 29 Day

Anticipated trial start date

2018 Year 06 Month 08 Day

Last follow-up date

2019 Year 08 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

2017 Year 10 Month 19 Day

Last modified on

2021 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031895


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name