UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sodium glucose cotransporter inhibitor 2, Tofogliflozin versus glimepiride, comparative trial in Patients with type 2 diabetes On Body composition (STOP-OB study)
Title of the study (Brief title)	Sodium glucose cotransporter inhibitor 2, Tofogliflozin versus glimepiride, comparative trial in Patients with type 2 diabetes On Body composition (STOP-OB study)
Region	Japan

Condition
Condition	Type 2 Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects (efficacy) of a SGLT2 inhibitor (tofogliflozin hydrate) as an add-on treatment on body weight, body fat and insulin resistance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in body fat percentage from baseline to the 24th week
Key secondary outcomes	Examine the following indexes from baseline to the 24th week 1. Change in body composition other than body fat percent (fat mass, lean body mass, muscle mass, amount of body water, body water percentage, estimated bone mass, basal metabolic rate, level of basal metabolism, visceral fat level, leg muscle score, degree of obesity) 2. Change in body weight, abdominal circumstance, BMI 3. Change in indexes related to glycemic control and beta-cell function: HbA1c, blood glucose level, insulin level, C-peptide, glucagon, HOMA-beta, HOMA-R 4. Change in indexes related to lipid metabolism and arteriosclerosis: TC, HDL-C, TG, LDL-C, adiponectin, leptin 5. Indexes related to liver function: AST, ALT, gamma GTP, ketone body (total ketone, acetoacetic acid, beta hydroxybutyric acid), type IV collagen (7S), ferritin, hyaluronic acid 6. Change in indexes related to diabetic renal disease or renal function: serum creatinine, urinary albumin, eGFR 7. Change in uric acid 8. Occurrence rate of any adverse event related to the study drugs 9. Medication adherence

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: Administer tofogliflozin Patients in this tofogliflozin group orally take tofogliflozin 20 mg once a day before breakfast for 24 weeks.
Interventions/Control_2	Group B: Administer glimepiride Patients in this glimepiride group start with glimepiride 0.5 mg, and also orally take it once a day before breakfast for 24 weeks.
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	Patients who meet all of the following criteria are included in this study. 1. Patients with type 2 diabetes 2. Patients who have used a dual treatment of a DPP-4 inhibitor with metformin for 4 weeks or longer until consenting *Those who have not changed the type of DPP-4 inhibitor or metformin as well as the dosage and administration within that time period **The dosage of metformin must be in the range of 500 mg per day or more but no more than 1,500 mg per day 3. Patients with HbA1c 7.0% or higher, and lower than 9.0% at the time of giving their consent 4. Female and male patients at age of 20 or older, and younger than 75 years of age 5. Patients who can give their consent in a written form
Key exclusion criteria	Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with type 1 diabetes or secondary diabetes 2. Patients who have used antidiabetic medication other than DPP-4 inhibitors or metformin (e.g. insulin, GLP-1 receptor agonist) within the 12 weeks until consenting 3. Patients who have changed the dosage of a diuretic agent or started a new diuretic agent within the 12 weeks until consenting 4. Patients with BMI below 18.5 kg/m2 or BMI 35 kg/m2 or higher at the time of consenting 5. Patients with conditions contraindicated the use of study drugs 6. Patients with a medical history of hypersensitivity to the study drugs 7. Patients with moderate to severe renal function impairment, or at the terminal stage of renal failure (eGFR< 60mL/min/1.73m2) 8. Patients with severe hepatic impairment 9. Patients with a medical history of stroke or cerebral infarction 10. Patients who are currently or possibly pregnant, breastfeeding or planning to be pregnant 11. Patients with moderate to severe heart failure (New York Heart Association [NYHA] functional class III or higher) 12. Patients with urinary tract infection or genital infection 13. Patients currently with a malignancy, or with a medical history of a malignancy (excluding those who are not currently treated for the malignancy or show no redevelopment of it, or a physician assures no relapse during the study period) 14. Patients with other conditions that investigators/physicians think inappropriate to join the study
Target sample size	64

Research contact person
Name of lead principal investigator	Professor Hisamitsu Ishihara
Organization	Nihon University
Division name	Division of Diabetes and Metabolic Diseases, School of Medicine
Address	30-1 Oyaguch-Kamicho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	ishihara.hisamitsu@nihon-u.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Address	NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Japan society for Patient Reported Outcome
Institute
Department

Funding Source
Organization	Kowa Company, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 01 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	2017 Year 02 Month 16 Day
Last modified on	2019 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030062