UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020314
Receipt No. R000023449
Scientific Title Effects of sodium/glucose cotransporter 2 (SGLT2) inhibitors on metabolic parameters in patients with type 2 diabetes: A chart-based analysis
Date of disclosure of the study information 2015/12/22
Last modified on 2016/12/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of sodium/glucose cotransporter 2 (SGLT2) inhibitors on metabolic parameters in patients with type 2 diabetes: A chart-based analysis
Acronym Effects of SGLT2 inhibitors in patients with type 2 diabetes
Scientific Title Effects of sodium/glucose cotransporter 2 (SGLT2) inhibitors on metabolic parameters in patients with type 2 diabetes: A chart-based analysis
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisayuki Katsuyama
Organization National Center for Global Health and Medicine Kohnodai Hospital
Division name Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Hisayuki Katsuyama
Organization National Center for Global Health and Medicine Kohnodai Hospital
Division name Department of Internal Medicine
Zip code
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)

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

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

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/27429679
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 12 Month 02 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.