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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007192
Receipt No. R000008437
Scientific Title Critical support for HIghly aged patients with BAsal insulin plus One oral therapy
Date of disclosure of the study information 2012/04/01
Last modified on 2015/08/24

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Basic information
Public title Critical support for HIghly aged patients with BAsal insulin plus One oral therapy
Acronym CHIBA-One study
Scientific Title Critical support for HIghly aged patients with BAsal insulin plus One oral therapy
Scientific Title:Acronym CHIBA-One 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 investigate usefulness of treating highly-aged patients with type 2 diabetes by once-daily dosing of the long-acting insulin with or without once-daily oral hypoglycemic agent
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood glucose-lowering effect to the target level and QOL satisfaction in elderly patients without any severe problem in management of diabetesby one-daily long acting insulin and once-daily oral agents
Key secondary outcomes Improvement of laboratory data including HbA1c, 1,5-AG and FPG, of frequency of hypoglycemia during the trial, and of the QOL score (Diabetes Treatment Satisfaction Questionnaire:DTSQ).

Base
Study type Interventional

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 long-acting insulin analogues including ultra-long acting insulin analogue and oral hypoglycemic agents
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with type 2 diabetes who are older than 65 y.o., and have been already receiving diet therapy and/or oral agents for more than 3 months, but not receiving any insulin therapy. The patients' HbA1c (NGSP) should be more than 7.9 % for at least the recent two months.
2. Introduce once-daily therapy with long-acting insulin analogue. Oral hypoglycemic agents may be added to the therapy.
Key exclusion criteria Patients who are ketosis-prone, have advanced renal failure or nephritic syndrome, proliferative retinopathy, severe cardiac disease, liver damage, and also who have active malignancies with poor prognosis. Patients who are impossible to do the self-injection therapy nor answer to the DTQS by themselves. Patients whom the doctors would judge as inappropriate for the inclusion should also be excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Sasaki
Organization The Jikei University School of Medicine
Division name Institute of Medical Research
Zip code
Address 163-10, Kashiwashita, Kashiwa-shi, Chiba 277-8567 Japan
TEL 04-7164-1111
Email tsasakiendo@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Yamashiro
Organization The Jikei University Kashiwa Hospital
Division name Division of Diabetes, Metabolism and Endocrinology
Zip code
Address 163-1 Kashiwashita, Kashiwa-shi, 277-8567 Chiba
TEL 04-7164-1111
Homepage URL
Email hiki@jikei.ac.jp

Sponsor
Institute The jikei University School of Medicine
Institute
Department

Funding Source
Organization Te Jikei University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tokyo Wemen's medical University Yachiyo medical center, Tokyo Dental College Ichikawa, Asahi central hospital, Japanese Red Cross Narita, and Funabashi Municipal Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 04 Month 01 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 There were only three patients included.
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 Completed
Date of protocol fixation
2012 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 01 Month 01 Day
Date trial data considered complete
2014 Year 02 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information Using a titration protocol for the intention to treat, patients should shift their insulin dose. Their mean FBG, HbA1c, 1.5AG, serum C-peptide and general biochemistry will be observed. At the start point of the insulin treatment, patients should be asked to answer the Satisfaction Questionaire (DTSQ). Six month later, patients will be asked again to answer to questionnaire for evaluation of their psychological effects by using long-acting insulin with using "Diabetes Treatment Satisfaction Questionaire (DTSQ).

Management information
Registered date
2012 Year 02 Month 01 Day
Last modified on
2015 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008437

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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