UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The examination of effects of adding on Tofogliflozin or not to add for type 2 diabetes controlled insufficiently by long-acting insulin glargine once daily with DPP-4 inhibitor or GLP-1 analog liraglutide with oral anti-diabetic agents (multicenter study)
Title of the study (Brief title)	Add Tofogliflozin to Oral anti-diabetic Medicine and once-daily Injection Combo (ATOMIC) Study
Region	Japan

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

Objectives
Narrative objectives1	For type 2 diabetes patients controlled inadequately with HbA1c 7.0 to 10.0%, taking oral anti-diabetic drugs including the DPP-4 inhibitors in addition to diet and exercise therapy for 12 weeks or more, to perform switching to human GLP-1 analog liraglutide or adding on long-acting insulin glargine once daily. It is intended to be compared the incidence of adverse events such as hypoglycemia and usefulness in glycemic control between two groups in multicenter.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. difference of glucose improvement by taking Tofo or not 2. difference of glucose improvement by the injection method
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Until December 2016. Assign randomly to a group adding Tofogliflozin and a group not to add for each 3 months. The subcutaneous injection once a day both groups. For glargine group, the attending physician dose adjusted according to the algorithm.
Interventions/Control_2	Group1:withTofo-WashOutPeriod-without Group2:without -WashOutPeriod-withTofo
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) Patients with HbA1c 7.0 to 10% (2) Patients who are registered in the clinical trial (UMIN000012224) (3) Adalts who are 20 years or older (4) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Key exclusion criteria	(1) Type 1 diabetes mellitus patients (2) Patients with severe liver disease (3) Patients with severe renal disease (4) Patients who had myocardial infarction within 3 months, or obvious heart failure case (5) Patients with severe pancreas disease (6) Patients having a cancer (7) Patients with hemoglobin (Hb) less than 11 g/dL (8) Patients that the number of the platelets is less than 100,000 /mm3 (9) Patients with high diabetic neuropathy (10) Patients having a proliferative retinopathy (11) Patients with a serious infectious disease or a serious injury (12) Patients with bowel disease or ileus factors (13) Chronic enteropathy patients with the digestion and absorption abnormality (14) Excessive common custom drinker (15) A pregnant woman or the woman who may be pregnant (16) Patients who was infected with hepatitis B virus or hepatitis C virus (17) In addition, the patient who judged inappropriate by an attendant physician
Target sample size	15

Research contact person
Name of lead principal investigator	Masahiko Miyagi
Organization	Toho University School of Medicine
Division name	Division of diabetes, metabolism and endocrinology
Address	6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL	03-3762-4151
Email	miyagi-m@med.toho-u.ac.jp

Public contact
Name of contact person	Masahiko Miyagi
Organization	Toho University School of Medicine
Division name	Division of diabetes, metabolism and endocrinology
Address	6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL	03-3762-4151
Homepage URL
Email	miyagi-m@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
Institute
Department

Funding Source
Organization	Toho University School of Medicine
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	大森赤十字病院内科（東京都），済生会横浜市東部病院糖尿病内分泌内科（神奈川県），ささもとクリニック（東京都），しんクリニック（東京都），徳島県立中央病院糖尿病・代謝内科（徳島県），徳島大学糖尿病臨床・研究開発センター（徳島県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 20 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2016 Year 04 Month 30 Day
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	Data analysis in

Management information
Registered date	2015 Year 03 Month 30 Day
Last modified on	2018 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018400