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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000014129 |
Receipt No. | R000016419 |
Scientific Title | Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus |
Date of disclosure of the study information | 2014/05/31 |
Last modified on | 2018/05/16 |
Basic information | ||
Public title | Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus | |
Acronym | AYUMI | |
Scientific Title | Assessment of safety and effectiveness: the clinical use of tofogliflozin in patients with type 2 diabetes mellitus | |
Scientific Title:Acronym | AYUMI | |
Region |
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Condition | ||
Condition | Type 2 diabetes mellitus | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the safety and efficacy of tofogliflozin under usual care |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The following side effects:events, grades, occurrence rates, etc
*Hypoglycemia *Urinary tract infection and Genital infection *Volume depletion (Dehydration, Polyuria/Pollakiuria, Hypotension) *Diabetic ketoacidosis *Renal dysfunction *Hepatic dysfunction *Fracture *Malignant tumor *Major adverse cerebro-cardiovascular events *Skin disorders |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Patients with Type 2 diabetes mellitus
2.Receiving tofogliflozin under usual care within 8 weeks before registration 3.Aged 20 and over 4.No use of SGLT2 inhibitor before tofogliflozin |
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Key exclusion criteria | 1.Hypersensitivity to tofogliflozin
2.Patients who had severe ketosis or diabetic coma or precoma 3.Severe infection or trauma, perioperative 4.End stage renal disease with hemodialysis or peritoneal dialysis 5.Patients whose participation is deemed inappropriate at the discretion of the attending physician |
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Target sample size | 10000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Japan Association for Diabetes Education and Care | ||||||
Division name | Academic commitee | ||||||
Zip code | |||||||
Address | 2-2-4 Kojimachi, Chiyoda-Ku, Tokyo, 102-0083 Japan | ||||||
TEL | 03-3514-1721 | ||||||
yamada@gipc.akita-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Japan Association for Diabetes Education and Care | ||||||
Division name | secretariat | ||||||
Zip code | |||||||
Address | 2-2-4 Kojimachi, Chiyoda-Ku, Tokyo, 102-0083 Japan | ||||||
TEL | 03-3514-1721 | ||||||
Homepage URL | http://www.nittokyo.or.jp/about/research/report/detail.php?t=1&p=13 | ||||||
shihara@nittokyo.or.jp |
Sponsor | |
Institute | Japan Association for Diabetes Education and Care |
Institute | |
Department |
Funding Source | |
Organization | Kowa Company, Ltd.
Kowa Pharmaceutical Co. Ltd. |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | A survey of commercially available drugs performed by physicians on a voluntary basis |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016419 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |