UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM): randomised crossover study
Title of the study (Brief title)	Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM)
Region	Japan

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

Objectives
Narrative objectives1	To compare the effect between Insulin glargine 300 U/ml + Tofogliflozin 20 mg + Insulin glargine 300 U/ml + Ipragliflozin 50 mg
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CGM AOC (70 mg/dL) for glycemic variability (0:00-6:00, 24:00) day2 day14
Key secondary outcomes	M-value (0:00-6:00, 24:00, 8:00-24:00) MAGE MODD ADRR mean glucose level (0:00-6:00, 24:00, 8:00-24:00) SD (0:00-6:00, 24:00, 8:00-24:00) Highest postprandial glucose level within 3 hours after each meal Time from start of meal to the highest postprandial glucose level Differences between preprandial and highest postprandial glucose level for each meal post-breakfast glucose gradient AUC (140 mg/dL) for glycemic variability within 3 h of each meal AUC (0 mg/dL) for glycemic variability in 24 h

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	CGM is attached after admission. Tofogliflozin 20 mg + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, Ipragliflozin 50 mg + Insulin glargine 300 U/ml are used on day 13 and day 14.
Interventions/Control_2	CGM is attached after admission. Ipragliflozin 50 mg + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, Tofogliflozin 20 mg + Insulin glargine 300 U/ml are used on day 13 and day 14.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	type 2 diabetic patients medicated Insulin glargine 300 U/ml for 3 month or longer
Key exclusion criteria	severe renal dysfunction (serum creatinine level over 2.0 mg/dL) judged to be unsuitable for participation for medical reasons
Target sample size	35

Research contact person
Name of lead principal investigator	Takeishi Soichi
Organization	General Inuyamachuo Hospital
Division name	Department of Diabetes
Address	6, futakozuka, goroumaru, Inuyama-city, Aichi
TEL	0568-62-8111
Email	souichi19811225@yahoo.co.jp

Public contact
Name of contact person	Takeishi Soichi
Organization	General Inuyamachuo Hospital
Division name	Department of Diabetes
Address	6, futakozuka, goroumaru, Inuyama-city, Aichi
TEL	0568-62-8111
Homepage URL
Email	souichi19811225@yahoo.co.jp

Sponsor
Institute	General Inuyamachuo Hospital
Institute
Department

Funding Source
Organization	General Inuyamachuo Hospital
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	2016 Year 09 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 07 Day
Anticipated trial start date	2016 Year 09 Month 07 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	2016 Year 09 Month 07 Day
Last modified on	2017 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027595