UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017838 |
|---|---|
| Receipt number | 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 09:34:11 |
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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
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
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020663
