UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033511
Receipt number R000038212
Scientific Title Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp in patients with type 2 diabetes
Date of disclosure of the study information 2018/07/26
Last modified on 2021/02/01 11:37:49

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Basic information

Public title

Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp in patients with type 2 diabetes

Acronym

Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp

Scientific Title

Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp in patients with type 2 diabetes

Scientific Title:Acronym

Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp

Region

Japan


Condition

Condition

Type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For type2 diabetes patients with insufficient control, to examine the improvement of the quality of life (QOL) and the glycemic effect, as basal insulin was switched to IDegAsp with changing from DPP-4 inhibitor to Liraglutide.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change in QOL scores from baseline to 3 months in patients with switched therapy to Liraglutide/IDegAsp.

Key secondary outcomes

Difference of change in HbA1c, body weight, units of insulin dose, frequency of hypoglycemia (SMBG), SD and CV % of FPG on SMBG, clinical and laboratory parameters


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1)Patients with type 2 diabetes treated with basal insulin and DPP-4 inhibitor.
2)HbA1c>7.5%
3)Patients who can respond to questionnaire survey.
4)Patients who gave written informed consent.

Key exclusion criteria

1)Patients with severe renal dysfunction including patients requiring hemodialysis or peritoneal dialysis(eGFR<30ml/min).
2)pregnant
3)Patients who have severe diabetic ketosis, diabetic coma.
4)Patients with severe infection, severe injury or perioperative state.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Tadashi
Middle name
Last name Yamakawa

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code

232-0024

Address

4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

naibunpi@urahp.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Marina
Middle name
Last name Harada

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code

232-0024

Address

4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

onyogora@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center
Department of Endocrinology and Diabetes

Institute

Department

Personal name



Funding Source

Organization

none

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

Medical Ethics Committee for Humans

Address

3-9 FukuuraKanazawa-ku, Yokohama City, Japan

Tel

0453707627

Email

rinri@yokohama-cu.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

横浜市立大学附属市民総合医療センター
浦舟金沢内科クリニック


Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 26 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

Terminated

Date of protocol fixation

2017 Year 08 Month 23 Day

Date of IRB

2017 Year 03 Month 29 Day

Anticipated trial start date

2017 Year 08 Month 24 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study based on the questionnaire
Diabetes therapy Related QOL(DTR-QOL)
Problem areas in diabetes survey (PAID)


Management information

Registered date

2018 Year 07 Month 25 Day

Last modified on

2021 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name