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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020316
Receipt No. R000023456
Scientific Title The COMparison of satisfaction between patient-led and physician-led titration groups Measured by QOL and self-efficacy scores In Japanese T2D patients study
Date of disclosure of the study information 2015/12/22
Last modified on 2019/07/08

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Basic information
Public title The COMparison of satisfaction between patient-led and physician-led titration groups Measured by QOL and self-efficacy scores In Japanese T2D patients study
Acronym The COMparison of satisfaction between patient-led and physician-led titration groups Measured by QOL and self-efficacy scores In Japanese T2D patients study
(The COMMIT-patient study)
Scientific Title The COMparison of satisfaction between patient-led and physician-led titration groups Measured by QOL and self-efficacy scores In Japanese T2D patients study
Scientific Title:Acronym The COMparison of satisfaction between patient-led and physician-led titration groups Measured by QOL and self-efficacy scores In Japanese T2D patients study
(The COMMIT-patient study)
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to evaluate how insulin U300 has effects on QOL and self-efficacy among type 2 diabetic patients who newly start insulin treatment. Also different methods of treatment, dosage adjustment by patients (Pt-led) and dosage adjustment by physicians (Ph-let) are compared for their effects on QOL and self-efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of changes in scores of PAID (The Problem Areas In Diabetes Scale) from baseline to the 24th week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A: the Pt-led group
Subjects adjust insulin dosage by themselves during the 24 weeks
* U300 as one unit per day is increased if there is no hypoglycemic signs in last 3 days (3 measurements), and FPG of those measurements are all 110mg/dl or higher
* U300 as one unit per day is reduced when casual blood glucose level is below 70 mg/dl
Interventions/Control_2 Group B: the Ph-led group
Physicians decide to change the insulin dosage (unit) during the 24 weeks
* Insulin dosage is increased through the physicians'/investigators' instruction, aiming for FPG below 110 mg/dl
* After patients feel to have hypoglycemia, they make a contact (by telephone, etc.) to their physicians/investigators, then the dosage (unit) adjustment is determined by the physicians/investigators
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.
1. Type 2 diabetic patients who newly start to use insulin, and are able to inject by themselves
2. Men and women at 20 years of age or older when providing their written consent
3. Patients who are diagnosed as type 2 diabetes for 6 months or longer
4. Use OHA for at least 3 months or longer
5. HbA1c is 7% or higher, and lower than 10%
6. BMI is 30.0 kg/m2 or lower
7. Can appropriately use SMBG (Self-Monitoring of Blood Glucose)
8. Can provide a written consent
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with dementia or possibly with dementia, or with psychological illness
2. Unable to make judgement for themselves, or incapable of reading and writing
3. Need a proxy's consent to join the study
4. With visual impairment which interferes with self-injection
5. Have an experience of using GLP-1 or insulin in the past
6. Currently on systemic steroid, beta-blocker, monoamine oxidase, etc., that may have an influence on glycemic control
7. If insulin is contradicted to use, or needs to be carefully used
8. Have an experience of myocardial infarction, angina, stroke, or cerebral infarction within 6 months before the baseline
9. With liver failure (ALT is doubled or higher than that of the upper limit in healthy individuals)
10. With renal impairment (SCr is 125 mumol/L or higher (1.4 mg/dL or higher) among men, and is 110 mumol/L or higher (1.3 mg/dL or higher) among women
11. Possibly pregnant or pregnant, or plant to be pregnant during the study period
12. Currently have malignancy, or had it in the past
13. Any condition that physicians think to be inappropriate to join the study
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor Hitoshi Ishii
Organization Nara Medical University
Division name Department of Diabetology
Zip code
Address 840 Shijo-cho,Kashihara, Nara, Japan
TEL 0744-22-3051
Email info@japanpro.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
TEL 03-3295-1350
Homepage URL
Email akayama@soiken.com

Sponsor
Institute Japan society for Patient Reported Outcome
Institute
Department

Funding Source
Organization Sanofi K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2015 Year 12 Month 22 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
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
2015 Year 12 Month 18 Day
Date of IRB
2015 Year 12 Month 17 Day
Anticipated trial start date
2016 Year 01 Month 15 Day
Last follow-up date
2018 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 22 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023456

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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