UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021629
Receipt number R000024946
Scientific Title Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial
Date of disclosure of the study information 2017/01/01
Last modified on 2017/09/27 09:08:41

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Basic information

Public title

Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial

Acronym

Efficacy and safety of IDegAsp switching from basal insulin

Scientific Title

Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial

Scientific Title:Acronym

Efficacy and safety of IDegAsp switching from basal insulin

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To provide appropriate insulin dose recommendations when switching from basal insulin to IDegAsp.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in AUC-Glu during test meal loading before and after switching from basal insulin to IDegAsp

Key secondary outcomes

Change from baseline in insulin dose (U) after 4 weeks of treatment
Changes from baseline in FPG, GA, and 1,5-AG after 4 weeks of treatment
Beta-cell stress assessed by the change of plasma intact proinsulin / C-peptide ratio


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

basal insulin

Interventions/Control_2

IDegAsp

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

Outpatients
Current oral antidiabetic drug(s) treatment with Iglar or IDeg
7.0% <= HbA1c <= 9.0%
BMI <=35 kg/m2

Key exclusion criteria

The exclusion criteria were pregnancy, severe illness, CKD (eGFR < 30 ml/min/1.73m2), and malignancy.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasushi Tanaka

Organization

St. Marianna University School of Medicine

Division name

Division of Metabolism and Endocrinology, Department of Internal Medicine

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

044-977-8111

Email

smu.tainai@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoshio Nagai

Organization

St. Marianna University School of Medicine

Division name

Division of Metabolism and Endocrinology, Department of Internal Medicine

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

044-977-8111

Homepage URL


Email

ynagai@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



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

聖マリアンナ医科大学病院


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1111/jdi.12748/epdf

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

2016 Year 03 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2016 Year 11 Month 30 Day

Date of closure to data entry

2016 Year 12 Month 31 Day

Date trial data considered complete

2016 Year 12 Month 31 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 27 Day

Last modified on

2017 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024946


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name