UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabetes mellitus
Title of the study (Brief title)	Effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabetes mellitus
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on muscle strength in patients with type 2 diabete
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	grip strength, quadriceps muscle strength
Key secondary outcomes	abdominal fat free area and visceral fat area, Hemoglobin A1C levels, pre/postprandial blood glucose levels, BMI

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	Sodium-dependent glucose co-transporter 2 inhibitors(SGLT2 inhibitors)
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Outpatients 2) Inadequate glucose control even after dietary, exercise and drug therapies for more than 8 weeks 3) HbA1c 6.5 - 10.0% 4) Fasting blood glucose levels 110 - 250mg/dl 5) Patients who themselves can voluntarily provide consent to participate in this study, and can also follow the study protocol
Key exclusion criteria	1) Type 1 diabetes 2) Had ketosis or coma within 6 month 3) Secondary diabetes 4) Patients receiving GLP-1 analogue therapy 5) Poor-controlled diabetes (HbA1c>=10.0 % or fasting blood glucose levels>=250mg/dl) 6) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 7) Patients with complication of severe hepatic disorder, e.g., hepatocirrhosis 8) Renal insufficiency: Ccr<45 mL/min/1.73m2 9) Patients who have serious complication of gastrointestinal disorders or who underwent a surgical operation that is known to affect the absorption of a drug by digestive tract 10) Patients who are susceptible to dehydration 11) Patients who is a chronic heavy drinker 12) Patients with history of urinary infection or genital infection disease 13) Malignancies or other diseases with poor prognosis 14) Pregnant 15) Subjects whose doctor in charge do not agree to join the trial
Target sample size	30

Research contact person
Name of lead principal investigator	Satoshi Ida
Organization	Ise Red Cross Hospital
Division name	Department of Metabolic Diseases
Address	471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL	0596-28-2171
Email	bboy98762006@yahoo.co.jp

Public contact
Name of contact person	Satoshi Ida
Organization	Ise Red Cross Hospital
Division name	Department of Metabolic Diseases
Address	471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL	0596-28-2171
Homepage URL
Email	bboy98762006@yahoo.co.jp

Sponsor
Institute	Ise Red Cross Hospital Department of Metabolic Diseases
Institute
Department

Funding Source
Organization	Ise Red Cross Hospital Department of Metabolic Diseases
Organization
Division
Category of Funding Organization	Self funding
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 07 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 22 Day
Anticipated trial start date	2015 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2015 Year 07 Month 21 Day
Last modified on	2019 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021265