UMIN-CTR Clinical Trial

Basic information
Public title	The clinical study to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients treated with a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor
Acronym	The clinical study to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients treated with a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor
Scientific Title	The clinical study to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients treated with a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor
Scientific Title:Acronym	The clinical study to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients treated with a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor
Region	Japan

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

Objectives
Narrative objectives1	To assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients of type 2 diabetes mellitus treated with an SGLT2 inhibitor (Luseogliflozin), which inhibits glucose reabsorption from renal uriniferous tubule, on glucose variability by using continuous glucose monitoring (CGM), and to establish dietary therapy which reduces the risk of hypoglycemia in patients treated with SGLT2 inhibitors. Also, to collect blood and urine samples for metabolome analysis that will be performed as an extension study of the clinical study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of profile of blood glucose level using CGM
Key secondary outcomes	Clinical laboratory tests Vital signs Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	High GI meal containing 55% carbohydrate
Interventions/Control_2	Low GI meal containing 55% carbohydrate
Interventions/Control_3	High GI meal containing 40% carbohydrate
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Japanese patients with type 2 diabetes (2) Patients aged 20 to 64, inclusive, when obtaining written informed consent, regardless of sex (3) Patients with HbA1c (NGSP) between 7.0 and 10.0 % at screening examination or patients with HbA1c (NGSP) <= 10.0 % (no lower limit) at screening examination if they receive one kind of hypoglycemic drug (oral hypoglycemic drug or GLP-1 receptor agonist) (4) Patients with BMI >= 20 kg/m2 and < 30 kg/m2 (5) Outpatients (6) Patients who was explained about the clinical study, understood the content of the study, and gave written informed consent before participating in the clinical study
Key exclusion criteria	(1)Patients who are diagnosed as diabetes mellitus other than type 2 diabetes, e.g., type 1 diabetes, diabetes with specific mechanism or disease except for type 2 diabetes, pregnancy diabetes (2) Patients with complication of severe kidney dysfunction, e.g., nephrotic syndrome, renal failure, dialytic therapy (3) Patients with eGFR < 45mL/min/1.73m2 at screening examination (4) Patients with complication of severe hepatic disorder, e.g., hepatocirrhosis (5) Patients with complication of severe heart disease, e.g., cardiac infarction, cardiac failure, or of cerebral infarction, or patients with medical history of those within 6 months prior to the initiation of the clinical study (obtaining informed consent) (6) 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 (7) Patients with diabetic microangiopathy, e.g., retinopathy of diabetes, diabetic neuropathy, or others which cannot be fully controlled regardless of continuing treatment (8) Patients who are susceptible to dehydration (Patients with extremely poorly-controlled glycemia) (9) Patients with complication of malignancy (Patients who recovered from malignancy are permitted to participate in the clinical study) (10) Patients with a history of hypersensitivity to Luseogliflozin (11) Patients who is a chronic heavy drinker (12) Female patients who are pregnant, possibly pregnant, or breast-feeding (13) Other patients who are judged as ineligible for enrollment in the clinical study by the principal investigator or subinvestigator
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yutaka Seino
Organization	Kansai Electric Power Hospital
Division name	President
Zip code
Address	2-1-7 Fukushima-ku, Osaka 553-0003, Japan
TEL	06-6458-5821
Email	seino.yutaka@e2.kepco.co.jp

Public contact
Name of contact person	1st name Middle name Last name Daisuke Yabe
Organization	Kansai Electric Power Hospital
Division name	Center for Metabolism and Clinical Nutrition
Zip code
Address	2-1-7 Fukushima-ku, Osaka 553-0003, Japan
TEL	06-6458-5821
Homepage URL
Email	ydaisuke-kyoto@umin.ac.jp

Sponsor
Institute	Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization	Taisho Toyama Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Medical Corporation Heishinkai OCROM Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02500186
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人 平心会　OCROMクリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 09 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 20 Day
Last follow-up date	2015 Year 07 Month 17 Day
Date of closure to data entry	2015 Year 11 Month 20 Day
Date trial data considered complete	2015 Year 11 Month 20 Day
Date analysis concluded	2016 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 08 Day
Last modified on	2016 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020663

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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