UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of appropriate nutrient intake for patients treated with sodium-glucose-cotransporter-2 inhibitor.
Title of the study (Brief title)	Effect of SGLT2 inhibitor on nutrient intake
Region	Japan

Condition
Condition	type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of dapaglifozin on the change of nutrient intake and body composition in type2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nutrient intake (at 0.4.12 weeks after administration, estimated by brief-type self-administered diet history questionnaire) Body composition(at 0.12 weeks after administration, calculated by DEXA)
Key secondary outcomes	Fasting plasma glucose,GA,HbA1c Liver function,renal function,serum keton body, lipid level,serum glucagon,C-peptide Blood pressure,body weight,etc.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administiration of dapagliflozin(5mg/day)
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	30 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Outpatient treatment at our medical center
Key exclusion criteria	1. Patients with hypersensitivity to Dapaglifozin 2. Type1 diabetes 3. Subjects with severe ketosis,diabetic coma or precoma 4. Subjects with severe infection,befor and after surgery or severe injury 5. Pregnancy 6. Past history of acute coronary syndrome 7. Malignancy 8. Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size	30

Research contact person
Name of lead principal investigator	Tatsuhide Inoue
Organization	Shizuoka General Hospital
Division name	Center of Diabetes and endoclinology
Address	4-27-1,Kita-Ando,Aoi-ku,Shizuoka,Japan
TEL	054-247-6111
Email	tatsuhide-inoue@i.shizuoka-pho.jp

Public contact
Name of contact person	Rieko Kosugi
Organization	Shizuoka General Hospital
Division name	Center of Diabetes and endoclinology
Address	4-27-1,Kita-Ando,Aoi-ku,Shizuoka,Japan
TEL	054-247-6111
Homepage URL
Email	fwkh7040spring@yahoo.co.jp

Sponsor
Institute	Shizuoka General 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	2017 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 25 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 02 Month 14 Day
Date trial data considered complete	2017 Year 02 Month 14 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 05 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029393