UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016131 |
|---|---|
| Receipt number | R000018734 |
| Scientific Title | Investigation for clinical efficacy and safety of ipragliflozin 50mg and 100mg on type 2 diabetes |
| Date of disclosure of the study information | 2015/01/06 |
| Last modified on | 2022/07/13 14:27:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation for clinical efficacy and safety of ipragliflozin 50mg and 100mg on type 2 diabetes
Acronym
HARUKA study
Scientific Title
Investigation for clinical efficacy and safety of ipragliflozin 50mg and 100mg on type 2 diabetes
Scientific Title:Acronym
HARUKA study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for clinical efficacy and safety of SGLT-2 inhibitor, ipragliflozin 50mg and 100mg on type 2 diabetes under usual care.
In addition, to investigate an exploratory influence factor analysis of clinical efficacy and safety on ipragliflozin treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Changes of HbA1c at 52weeks treatment after initiation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Poorly-controlled Type II diabetes with diet and exercise therapy or additional treatment of various diabetic drugs
2) Changes within +- 0.5% of HbA1c
3) 6.5%<HbA1C<10%
4) Written informed consent by each subjects
5) BMI>20kg/m2
Key exclusion criteria
1) Type 1 diabetes, patients with other types of diabetes or pregnancy diabetes
2) History of severe ketoacidosis diabetic coma or profound come within 6 months
3) Severe infection, perioperative or severe trauma
4) Moderate renal insufficiency(male >1.5mg/dL, female>1.3mg/dL)
5) Severe hepatic impairment
6) History of requirement of hospitalization for severe CV event within 6 months other
7) Patients with pregnancy, breast-feeding, childbearing potential or plan of pregnancy
8) Patients with neuropathic bladder or dysuria
9) Patients with treatment of diuretic drug
10) Patients with SGLT2 treatment at start of this study
11) Patients who has an episode of sensitivity of SGLT-2
12) Patients who are not eligible judged by investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Haruo |
| Middle name | |
| Last name | Nishimura |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Division of diabetes and endocrinology
Zip code
530-0012
Address
2-10-39, Shibata Kita-Ku, Osaka, 530-0012, Japan
TEL
06-6372-0333
hnis@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruo |
| Middle name | |
| Last name | Nishimura |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Division of diabetes and endocrinology
Zip code
530-0012
Address
2-10-39, Shibata Kita-Ku, Osaka, 530-0012, Japan
TEL
06-6372-0333
Homepage URL
hnis@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Osaka Saiseikai Nakatsu Hospital
Division of diabetes and endocrinology
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Translational Research Informatics Center,
Foundation for Biomedical Research and Innovation, Kobe, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Saiseikai Nakatsu Hospital
Address
2-10-39, Shibata, Kita-ku-Osaka Japan
Tel
06-6372-0333
23001@nakatsu.saiseikai.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
TRIEND1413
Org. issuing International ID_1
Translational Research Informatics Center,
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪赤十字病院（大阪府）、大歳内科（大阪府）、大阪府立急性期・総合医療センター（大阪府）、大阪府済生会茨木病院（大阪府）、大阪府中津済生会病院（大阪府）、奥田内科クリニック（大阪府）、近畿大学医学部奈良病院、神戸市立中央市民病院（兵庫県）、医療法人北辰会有澤総合病院（大阪府）、馬場内科クリニック（大阪府）、医療法人大歳内科（大阪府）、浜松医療センター（静岡県）、佐久市立国保浅間総合病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 05 | Month | 30 | Day |
Other
Other related information
To evaluate for clinical efficacy and safety of SGLT-2 inhibitor, ipragliflozin 50mg and 100mg on type 2 diabetes under usual care.
In addition, to investigate an exploratory influence factor analysis of clinical efficacy and safety on ipragliflozin treatment.
Management information
Registered date
| 2015 | Year | 01 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018734
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
