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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017838
Receipt No. R000020663
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
Date of disclosure of the study information 2015/06/09
Last modified on 2016/12/09

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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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