UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034083
Receipt number R000038812
Scientific Title Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/05 21:54:17

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Basic information

Public title

Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes

Acronym

Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes

Scientific Title

Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes

Scientific Title:Acronym

Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the efficacy of GLP-1 receptor agonists as an add-on therapy to insulin for steroid-induced hyperglycemia in patients with diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic control and total daily insulin dose

Key secondary outcomes

Glycemic variation, adverse events including hypoglycemia, body weight, blood pressure, and lipid profile


Base

Study type

Interventional


Study design

Basic design

Parallel

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

treat patients with insulin

Interventions/Control_2

treat patients with insulin and GLP-1 receptor agonists

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

1) Subjects with diabetes
2) Subjects who routinely take oral or intravenous steroids
3) Subjects who agree to participate in the study with oral and written informed consent

Key exclusion criteria

1) Subjects who refuse to participate in the study
2) Subjects who type 1 diabetes
3) Subjects with insulin-dependent diabetes
4) Subjects who used GLP-1 receptor agonists within one month
5) Subjects who are critically ill
6) Subjects who have difficulty participating in the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiro Hamasaki

Organization

Tazuke Kofukai Medical Research Institute, Kitano Hospital

Division name

Center for diabetes and endocrinology

Zip code


Address

2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN, 530-8480

TEL

06-6312-1221

Email

a-hamasaki@kitano-hp.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Yoshiji

Organization

Tazuke Kofukai Medical Research Institute, Kitano Hospital

Division name

Center for diabetes and endocrinology

Zip code


Address

2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN, 530-8480

TEL

06-6312-1221

Homepage URL


Email

s-yoshiji@kitano-hp.or.jp


Sponsor or person

Institute

Center for diabetes and endocrinology, Tazuke Kofukai Medical Research Institute, Kitano Hospital

Institute

Department

Personal name



Funding Source

Organization

Center for diabetes and endocrinology, Tazuke Kofukai Medical Research Institute, Kitano Hospital

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

公益財団法人田附興風会医学研究所 北野病院


Other administrative information

Date of disclosure of the study information

2018 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

Preinitiation

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 10 Day

Last modified on

2018 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038812


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name