UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen.
Title of the study (Brief title)	Efficacy of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen (ECLIPS).
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 aim of this study is to assess the efficacy and safety of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The reduction degree of the HbA1c in 12 and 24 weeks.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	The group which changes ultra-rapid insulin to canagliflozin 100mg p.o. for 24 weeks.
Interventions/Control_2	The group which changes ultra-rapid insulin to liraglutide 0.9mg s.c. 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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) We screened type 2 diabetic patients who regularly attended Toho University Oomori Hospital. (2) Disease duration 1 to 25 years. (3) Patient taking basal-bolus insulin therapy, with insulin glargine or insulin degurudegu, and ultra-rapid insulin more than 6 months. (4) Glycated hemoglobin (HbA1c) of less than 7.5%, and stable glycemic control with HbA1c variation less than 1.0% during the preceding 2 months. (5) Body mass index (BMI) is over 22. (6) Negative history of GLP-1 agonist. (7) Patient taking equal or less than two kinds of oral anti-diabetes drugs, except DPP-4 inhibitor or SGLT2 inhibitor. (8) Adults who are 20 years or older. (9) 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 or steroid induced diabetes mellitus. (2) Patients with aspartate aminotransferase or alanine aminotransferase more than 100 IU/L. (3) Patients with plasma creatinine more than 2.0mg/dL. (4) Patients who had myocardial infarction within 3 months. (5) Patients with severe pancreas disease (6) Patients taking cancer treatment (7) Patients with hemoglobin (Hb) less than 11 g/dL. (8) Patients whose the number of the platelets is less than 100,000 /mm3. (9) Patients with severe diabetic neuropathy (10) Patients having proliferative retinopathy. (11) Patients with serious infectious disease or operative state. (12) Patients with inflammatory bowel disease and chronic bowel disease. (13) Heavy alcohol drinkers. (14) Patients who are pregnant, hope to be pregnant, or are in lactation period. (15) Patients with positive of HBV or HCV. (16) In addition, the patients who will be judged inappropriate by an attendant physician.
Target sample size	40

Research contact person
Name of lead principal investigator	Takahisa Hirose
Organization	Toho University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541,Japan
TEL	03-3762-4151
Email	yasuyo@med.toho-u.ac.jp

Public contact
Name of contact person	Yasuyo Ando
Organization	Toho University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541,Japan
TEL	03-3762-4151
Homepage URL
Email	yasuyo@med.toho-u.ac.jp

Sponsor
Institute	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 17 Day
Anticipated trial start date	2015 Year 10 Month 19 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 10 Month 16 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022411