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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001952
Receipt No. 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

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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
Email

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
Email tsasaki-endo@umin.ac.jp

Sponsor
Institute jikei University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002378

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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