UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective study on beta cell function in type 2 diabetic patients using GLP-1 receptor agonist
Title of the study (Brief title)	A retrospective study on beta cell function in type 2 diabetic patients using GLP-1 receptor agonist
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy on beta cell functions in long-term-GLP-1 use
Basic objectives2	Others
Basic objectives -Others	To compare the effect of a GLP-1RA or DPP-4is
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum CPR level with glucagon challenge test
Key secondary outcomes	HbA1c level, Body weight

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	( a ) Beta cell function was assessed with Glucagon challenge test ( GCT ) which is using 1mg intravenous glucagon injection. ( b ) DPP4is or liraglutide was administrated for 5years. ( c ) 5 years after administration of DPP-is or liraglutide, beta cell function was re-assessed using GCT.
Key exclusion criteria	type 1 diabetes, an estimated glomerular filtration rate (eGFR) < 30ml/min, liver cirrhosis, steroid or any hyperglycemic drugs use and malignant desease
Target sample size	60

Research contact person
Name of lead principal investigator	Takeshi Yamamoto
Organization	Showa University of medicine
Division name	the department of internal medicine, the division of diabetology, metabolism and endocrinology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8947
Email	tak3105@med.showa-u.ac.jp

Public contact
Name of contact person	Takeshi Yamamoto
Organization	Showa University of medicine
Division name	the department of internal medicine, the division of diabetology, metabolism and endocrinology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8947
Homepage URL
Email	tak3105@med.showa-u.ac.jp

Sponsor
Institute	Showa University of medicine, the department of internal medicine, the division of diabetology, metabolism and endocrinology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	昭和大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 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	This study is retrospective cohort study analyzed data from the medical records of T2D patients treated with DPP-4is or liraglutide for 5 years. Those patients visited to Showa University Hospital between June 2010 and September 2017. The glucagon chellenge test was carried out before and 5 years after treatment.

Management information
Registered date	2018 Year 03 Month 13 Day
Last modified on	2018 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036201