UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014422 |
|---|---|
| Receipt number | R000016779 |
| Scientific Title | Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2015/07/01 16:21:27 |
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Basic information
Public title
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Acronym
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Scientific Title
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Scientific Title:Acronym
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between the non-administration group and the administration group of SGLT2 inhibitor
1) Change of s-dense-LDL (sd-LDL), IDL, LDL, VLDL and HDL
2) Change of body weight, blood pressure
3) Change of HOMA-beta, HOMA-IR, hsCRP
4) Change of serum creatinine, cystatin C and urinary albumin
5) Change of HbA1c and GA
6) To evaluate the change of dietary lifestyle (based on dietary habits questionnaire)
7) To evaluate the safety such as dehydration, urinary tract infection and genital infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Improving effects of sd-LDL, IDL, LDL and HDL using by Lipofo-AS
2) TC, TG, HDL-C, LDL-C, LDL/HDL-C rate and non HDL-C
Key secondary outcomes
1) Lowering effects of body weight and blood pressure
2) Improving effects of hsCRP, HOMA-beta and HOMA-R
3) Lowering effects of HbA1c and GA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks
Interventions/Control_2
Ipragliflozin non-administrated group (Continuation of conventional therapy)
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 to less than 65 years at providing consent
2) Type 2 diabetes patients with BMI >= 24 kg/m2
3) HbA1c (NGSP) was from 7% to less than 10% for 3 months or more, under conventional thrapy (HbA1c >= 7.5% in case of having sulfonylureas and glinides)
Key exclusion criteria
1) With receiving insulin therapy
2) With a history of ischemic heart disease (angina pectoris, myocardial infarction) and ischemic stroke
3) Serum Creatinine >= 1.2 mg/dL
4) Fasting serum triglycerides levels >= 400 mg/dL
5) HbA1c was changed 2% or more within 3 months
6) With unconscious thirst (impossible self-judgement water intake)
7) With contraindication for ipragliflozin
a) History of hypersensitivity to ipragliflozin
b) Severe ketosis, diabetic or precoma
c) Severe infection, pre or post surgery, and severe trauma
8) Considered as inadequate by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Bando |
Organization
Fukui-ken Saiseikai Hospital
Division name
internal
Zip code
Address
Funabashi 7-1, Wadanaka-cho, Fukui-city, Fukui, Japan
TEL
0776-23-1111
Y-BANDO@fukui.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Bando |
Organization
Fukui-ken Saiseikai Hospital
Division name
internal
Zip code
Address
Funabashi 7-1, Wadanaka-cho, Fukui-city, Fukui, Japan
TEL
0776-23-1111
Homepage URL
Y-BANDO@fukui.saiseikai.or.jp
Sponsor or person
Institute
Fukui-ken Saiseikai Hospital
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2015 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016779
| 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 |
