UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020314 |
|---|---|
| Receipt number | 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 15:41:16 |
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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
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
katsuyama-hs@umin.org
Sponsor or person
Institute
National Center for Global Health and Medicine Kohnodai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023449
