UMIN-CTR Clinical Trial

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