UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015876 |
|---|---|
| Receipt number | R000018476 |
| Scientific Title | Open prospective randomized controlled trials on efficacy of dapagliflozin and low carbohydrate diet on glycemic and lipid control |
| Date of disclosure of the study information | 2014/12/08 |
| Last modified on | 2017/01/18 12:47:31 |
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Basic information
Public title
Open prospective randomized controlled trials on efficacy of dapagliflozin and low carbohydrate diet on glycemic and lipid control
Acronym
Comparative testing by dapagliflozin and low carbohydrate diet
Scientific Title
Open prospective randomized controlled trials on efficacy of dapagliflozin and low carbohydrate diet on glycemic and lipid control
Scientific Title:Acronym
Comparative testing by dapagliflozin and low carbohydrate diet
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between dapagliflozin administration group and the conventional therapy+low carbohydrate diet group
1)the change of small, dense LDL(sd-LDL) and IDL, LDL, VLDL, and HDL
2) blood glucose level, HbA1c
3) body weight, blood pressure
4) HOMA-beta, HOMA-IR
5) the changes in the kidney-associated markers(serum Cr, cystatin and urinary albumin)
6)change of dietary lifestyle and behavioral changes
7) To evaluate the the safety of dehydration and the urinary tract infections and genital infections
(Mainly urinary sediment, urine culture wil be carried out.)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Improvement effect of sd-LDL and IDL and LDL, HDL using by Lipopho AS
2) Improvement effect of lipid general profile(TC, TG, HDL-C, LDL-C, LDL/HDL-C ratio, non HDL-C)
Key secondary outcomes
1)Lowering effect of body weight, blood pressure
2) Improvement effect of hs-CRP, HOMA-beta, and HOMA-IR
3) Lowering effect of HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Orally administration of 5mg dapagliflozin(usual dose) once a day for 24 weeks
Interventions/Control_2
Dapagliflozin non-administration group (continuation of conventional therapy group)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Aged from 20 less than 65 years at providing consent which is obtained in writing by voluntary
2)Patients with type 2 diabetes with BMI 24 kg/m2 or more
3)HbA1c(NGSP value) was from 7% to less than 10% for 3 months or more under convetional treatment (HbA1c>=7.5% in the case of SU agent or glinides drug users)
Key exclusion criteria
Patients
1)with receiving SGLT2 inhibitor, insulin, either GLP-1 receptor agonists
2)with obvious ischemic heart disease (angina pectoris, myocardial infarction), a history of ischemic cerebrovascular disease
3)male:serum Cr>=1.2 mg/dL
woman:serum Cr>=1.0 mg/dL
4)fasting serum triglyceride is greater than or equal to 400 mg/dL
5)HbA1c was changed more than 2% within 3 months
6)with unconscious thirst (impossible self-judgement enough water intake)
7)with contraindication for dapagliflozin
a)with a history of hypersensitivity to dapagliflozin
b)Severe ketosis, diabetic coma or precoma
c)Severe infection, before and after surgery, patients with severe trauma
8)Cosidered as inadequated by the investigator and doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
38 Morohongo, Moroyamacho, Irumagun, Saitama 350-0495, Japana
TEL
049-276-1875
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
38 Morohongo, Moroyamacho, Irumagun, Saitama 350-0495, Japana
TEL
049-276-1875
Homepage URL
i1901018@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
熊谷外科病院、間柴医院、坂戸内科医院、明海大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Date of protocol fixation
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 08 | Day |
Last modified on
| 2017 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018476
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
