UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020316 |
|---|---|
| Receipt number | 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 10:24:51 |
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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
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
akayama@soiken.com
Sponsor or person
Institute
Japan society for Patient Reported Outcome
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023456
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