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 UMIN000016921
Receipt No. R000019640
Scientific Title Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Date of disclosure of the study information 2015/03/26
Last modified on 2015/03/26

* 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 Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Acronym Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Scientific Title Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Scientific Title:Acronym Efficacy of SGLT2 inhibitors on bone mineral density 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 evaluate effects of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density compared to that of a young adult mean
Key secondary outcomes Hemoglobin A1c level, body mass index, renal function parameters in blood and urine and serum lipid profiles

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Luseogliflozin
Interventions/Control_2 Dapagliflozin
Interventions/Control_3 Tofogliflozin
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes patients.
Obtained written informed consent from the patients before participation.
Key exclusion criteria Complicated severe nephropathy.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Kusunoki
Organization Aichi Medical University
Division name Medical Clinic
Zip code
Address 2-12-1, Higashisakura, Higashi-ku, Nagoya
TEL 052-931-2261
Email info@tonyo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Kusunoki
Organization Aichi Medical University
Division name Medical Clinic
Zip code
Address 2-12-1, Higashisakura, Higashi-ku, Nagoya
TEL 052-931-2261
Homepage URL
Email info@tonyo.jp

Sponsor
Institute Akishima Clinic
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 医療法人社団あきしまクリニック(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 31 Day
Last follow-up date
2015 Year 03 Month 11 Day
Date of closure to data entry
2015 Year 03 Month 17 Day
Date trial data considered complete
2015 Year 03 Month 24 Day
Date analysis concluded
2015 Year 03 Month 25 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 26 Day
Last modified on
2015 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019640

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.