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

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 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


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

Value
https://center6.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