UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of sodium/glucose cotransporter 2 (SGLT2) inhibitors on metabolic parameters in patients with type 2 diabetes: A chart-based analysis
Title of the study (Brief title)	Effects of SGLT2 inhibitors in patients with type 2 diabetes
Region	Japan

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

Objectives
Narrative objectives1	To understand the effects of SGLT2 inhibitors on metabolic parameters in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	body weight, blood pressure, plasma glucose, HbA1c, serum low-density lipoprotein-cholesterol (LDL), triglyceride (TG), high-density lipoprotein-cholesterol (HDL), non-HDL-cholesterol (non-HDL), aspartate aminotransferase (AST), alanine aminotransferase (ALT), eGFR
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with type 2 diabetes, who had been prescribed SGLT2 inhibitors for 1 month or longer between April 2014 and November 2015
Key exclusion criteria	none
Target sample size	75

Research contact person
Name of lead principal investigator	Hisayuki Katsuyama
Organization	National Center for Global Health and Medicine Kohnodai Hospital
Division name	Department of Internal Medicine
Address	1-7-1 Kohnodai, Ichikawa, Chiba, 272-0034, Japan
TEL	+81-47-272-0034
Email	katsuyama-hs@umin.org

Public contact
Name of contact person	Hisayuki Katsuyama
Organization	National Center for Global Health and Medicine Kohnodai Hospital
Division name	Department of Internal Medicine
Address	1-7-1 Kohnodai, Ichikawa, Chiba, 272-0034, Japan
TEL	+81-47-272-0034
Homepage URL
Email	katsuyama-hs@umin.org

Sponsor
Institute	National Center for Global Health and Medicine Kohnodai Hospital
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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 02 Day
Anticipated trial start date	2015 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/27429679
Publication of results	Published
URL releasing results
Results
Other related information	We compared the data at baseline and at 1, 2, 3 and 6 months after the start of SGLT2 inhibitors. Body weight, blood pressure, plasma glucose, HbA1c, serum low-density lipoprotein-cholesterol (LDL), triglyceride (TG), high-density lipoprotein-cholesterol (HDL), non-HDL-cholesterol (non-HDL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in studied subjects were measured almost at the same time point at the baseline and at 1, 2, 3 or 6 months after the start of SGLT2 inhibitors.

Management information
Registered date	2015 Year 12 Month 22 Day
Last modified on	2016 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023449