UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001952 |
|---|---|
| Receipt number | R000002378 |
| Scientific Title | Critical support for HIghly aged patients with diabetes by BAsal insulin therapy |
| Date of disclosure of the study information | 2009/05/09 |
| Last modified on | 2012/07/22 12:02:33 |
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Basic information
Public title
Critical support for HIghly aged patients with diabetes by BAsal insulin therapy
Acronym
CHIBA study
Scientific Title
Critical support for HIghly aged patients with diabetes by BAsal insulin therapy
Scientific Title:Acronym
CHIBA 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 using the long-acting basal insulin, Levemir.
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 in elderly patients without any severe problem in management of diabetes
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
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
| 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, and/or Oral Agents for more than 3 months
2. Patients whose HbA1c are more than 7.6 % for at least recent 3 month
Key exclusion criteria
Patients who are ketosis-prone, who have advanced renal failure or nephritic syndrome, proliferative retinopathy, severe cardiac disease, liver damage, and active malignancies with poor prognosis. Patients who are impossible to do the self-injection therapy. Patients whom the doctors would judge as inappropriate for the inclusion should also be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Sasaki |
Organization
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sasaki |
Organization
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
tsasaki-endo@umin.ac.jp
Sponsor or person
Institute
jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Wemen's medical University Yachiyo, Tokyo Dental College Ichikawa, Asahi 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
| 2009 | Year | 05 | Month | 09 | 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
number of registration: zero. Now finalized.
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
| 2009 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | 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. Six month later, patients will be asked 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
| 2009 | Year | 05 | Month | 09 | Day |
Last modified on
| 2012 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002378
