UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023914
Receipt number R000027439
Scientific Title The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Date of disclosure of the study information 2016/10/01
Last modified on 2018/09/04 11:18:29

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Basic information

Public title

The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus

Acronym

The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus

Scientific Title

The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus

Scientific Title:Acronym

The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigete the change on efficacy and safety associated with a switch from basal insulin to dulaglutide in patients with type 2 diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of continuous glucose monitoring when switching from basal insulin to dulaglutide

Key secondary outcomes

HbA1c and body waight after 24 weeks,QOL wtih DTSQ,occurrence of hypoglycemia


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We measure continuous glucose monitoring when switching basal insulin to dulaglutide. We measure the QOL of DTSQ at baseline of therapy with basal insulin and at after 24 weeks of therapy with dulaglutide.

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

The inclusion criteria were age => 20 years, diagnosis of type 2 diabetes, treatment with basal insulin for at least 24 weeks before entry into this study, and less than 1.0% HbAic change during the 24 weeks before entry into this study

Key exclusion criteria

1,Type 1 diabetes mellitus
2,Any patient who could not understand the device of ATEOS and DTSQ questionnaire
3,Any other condition which the attending physician feels would interfere with trial participation

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mohiriho Okada

Organization

Japan Community Healthcare Organization Kanazawa Hospital

Division name

Department of Pharmacy

Zip code


Address

Ha-15 Oki-machi, Kanazawa City, Ishikawa, Japan

TEL

076-252-2200

Email

okada-knz@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mohiriho Okada

Organization

Japan Community Healthcare Organization Kanazawa Hospital

Division name

Department of Pharmacy

Zip code


Address

Ha-15 Oki-machi, Kanazawa City, Ishikawa, Japan

TEL

076-252-2200

Homepage URL


Email

okada-knz@umin.ac.jp


Sponsor or person

Institute

Japan Community Healthcare Organization Kanazawa Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Community Healthcare Organization Kanazawa Hospital

Organization

Division

Category of Funding Organization

Japanese Governmental office

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



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 01 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

Completed

Date of protocol fixation

2015 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 09 Month 02 Day

Last modified on

2018 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027439


Research Plan
Registered date File name
2017/09/05 デュラグルチド研究計画書ver2正本.doc

Research case data specifications
Registered date File name
2017/09/05 Dulaglutide仕様書.xlsx

Research case data
Registered date File name
2017/09/05 Dulaglutideデータ.xlsx