UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007192 |
|---|---|
| Receipt number | 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 06:17:29 |
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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
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
hiki@jikei.ac.jp
Sponsor or person
Institute
The jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008437
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
