UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038149
Receipt number R000043485
Scientific Title Efficacy of thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients with type 2 diabetes on maintenace hemodialysis teratment
Date of disclosure of the study information 2019/10/20
Last modified on 2019/09/29 20:52:59

* 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

Efficacy of thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients with type 2 diabetes on maintenace hemodialysis teratment

Acronym

thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients

Scientific Title

Efficacy of thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients with type 2 diabetes on maintenace hemodialysis teratment

Scientific Title:Acronym

thrice-weekly long-acting insulin degludec provided by nurses in handicapped patients

Region

Japan


Condition

Condition

type2 diabetes on hemodialysis treatment

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the efficacy of thrice-weekly long-acting insulin degludec provided by nurses in hadicapped patients with type2 dabetes on maitenace hemodialysis ntreatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

control of blood glucose status at 3 months after fixting insulin dosage

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. type 2 diabetes
2. hemodialysis patients
3. poor control of blood glucose even after dietary therapy and OHA
4. self-injection is impossible

Key exclusion criteria

1. type 1 diabetes
2. self-injection is impossible

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Toshiyuki
Middle name
Last name Nakao

Organization

Organization for Kidney and Metabolic Disease Ttreatment

Division name

Bouosei nishishinjuku shinryojo

Zip code

160-0023

Address

3-12-12, Nishishinjuku, Shinjuku ward, Tokyo, 160-0023, Japan

TEL

03-5340-5680

Email

t-nakao@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Toshiyuki
Middle name
Last name Nakao

Organization

Organization for Kidney and Metabolic Disease Ttreatment

Division name

Bouosei nishishinjuku shinryojo

Zip code

160-0023

Address

3-12-12, Nishishinjuku, Shinjuku ward, Tokyo, 160-0023, Japan

TEL

03-5340-5680

Homepage URL


Email

t-nakao@tokyo-med.ac.jp


Sponsor or person

Institute

Organization for Kidney and Metabolic Disease Ttreatment

Institute

Department

Personal name



Funding Source

Organization

Organization for Kidney and Metabolic Disease Ttreatment

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization

Toyu Ethics Review Committee for Medical Study

Address

9-10, Saiwaichou, Atsugi city, Kanagawa prefecture

Tel

046-220-1704

Email

h sagehasi@mtz.co.jp


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

望星西新宿診療所 Bousei Nishishinnjuku Shinryoujo


Other administrative information

Date of disclosure of the study information

2019 Year 10 Month 20 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

2019 Year 09 Month 10 Day

Date of IRB

2019 Year 10 Month 20 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2019 Year 11 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothoing


Management information

Registered date

2019 Year 09 Month 29 Day

Last modified on

2019 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043485


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name