UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015952 |
|---|---|
| Receipt number | R000018559 |
| Scientific Title | Study of the change of dietary intake and contents after taking selective SGLT2 inhibitor, Ipragliflozin |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2014/12/15 15:44:34 |
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Basic information
Public title
Study of the change of dietary intake and contents after taking selective SGLT2 inhibitor, Ipragliflozin
Acronym
Selective SGLT2 inhibitor, Ipragliflozin and the change of a meal
Scientific Title
Study of the change of dietary intake and contents after taking selective SGLT2 inhibitor, Ipragliflozin
Scientific Title:Acronym
Selective SGLT2 inhibitor, Ipragliflozin and the change of a meal
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
New oral hypoglycemic agent, Ipragliflozin is selective inhibitor of SGLT2 and show the improvement of blood glucose control and the effect of losing weight. We study the efficacy and safety for Ipragliflozin in patients with type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
Many studies report that the effect of losing weight stops within a certain period. We investigate the change of dietary habit on the hypothesis that a stop of losing weight caused by the change of dietary intake and contents after taking SGLT2 inhibitor, Ipragliflozin.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
We investigate HbA1c, GA, body weight, waist circumstance, body composition, and appearance of harmful phenomenon at initial and screening visits (3 month, 6 month, and 12 month after taking Ipragliflozin).
Key secondary outcomes
We investigate the dietary intake and contents at initial and screening visits (3 month, 6 month, and 12 month after taking Ipragliflozin).
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ipragliflozin
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with type 2 diabetes mellitus
2) Patients with not enough blood glucose control (HbA1c > 7.0%) even if putting dietary therapy, exercise, education for improvement of a daily habit, and medicinal treatment into practice
Key exclusion criteria
1) Patients with allergy for Ipragliflozin
2) Patients got severe ketosis, diabetic coma, and diabetic precoma during the past 6 months
3) Patients with severe infectious disease and injury, and in perioperative
4) Patients with renal dysfunction at a moderate level or high
5) Patients whose doctor judges to unfit for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Murakami Hiroshi |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5 Zaifu-cho, Hirosaki, Aomori-ken
TEL
0172-39-5062
sannai@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Murakami Hiroshi |
Organization
Hirosaki University Graduate School of Medicine
Division name
Endocrinology and Metabolism
Zip code
Address
5 Zaifu-cho, Hirosaki, Aomori-ken
TEL
0172-39-5062
Homepage URL
sannai@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
A society for the study of SGLT2 in Aomori-ken
Institute
Department
Personal name
Funding Source
Organization
A society for the study of SGLT2 in Aomori-ken
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Astellas Pharma Inc.
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
青森県立中央病院糖尿病センター（青森県）、青森市民病院糖尿病・内分泌内科（青森県）、工藤内科クリニック（青森県）、村上病院糖尿病内科（青森県）、木村健一クリニック（青森県）、弘前市立病院内分泌代謝科（青森県）、黒石病院糖尿病・内分泌内科（青森県）、今村クリニック（青森県）、五日市内科医院（青森県）、八戸市民病院内分泌・糖尿病科（青森県）、青森労災病院糖尿病・内分泌内科（青森県）、中園内科クリニック（青森県）、向井田胃腸科内科（青森県）、大館市立総合病院糖尿病・内分泌・神経内科（秋田県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018559
