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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016131
Receipt No. 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 2016/12/12

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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
Middle name
Last name Haruo Nishimura
Organization Osaka Saiseikai Nakatsu Hospital
Division name Division of diabetes and endocrinology
Zip code
Address 2-10-39, Shibata Kita-Ku, Osaka, 530-0012, Japan
TEL 06-6372-0333
Email hnis@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruo Nishimura
Organization Osaka Saiseikai Nakatsu Hospital
Division name Division of diabetes and endocrinology
Zip code
Address 2-10-39, Shibata Kita-Ku, Osaka, 530-0012, Japan
TEL 06-6372-0333
Homepage URL
Email hnis@kuhp.kyoto-u.ac.jp

Sponsor
Institute Osaka Saiseikai Nakatsu Hospital
Division of diabetes and endocrinology
Institute
Department

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
Address
Tel
Email

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
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.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


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