UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes
Title of the study (Brief title)	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	Akihiro Hamasaki
Organization	Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name	Center for diabetes and endocrinology
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	Satoshi Yoshiji
Organization	Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name	Center for diabetes and endocrinology
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
Institute	Center for diabetes and endocrinology, Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038812