UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006986 |
|---|---|
| Receipt number | R000008241 |
| Scientific Title | A clinical study of the correlation between QOL and the effects of oral anti-diabetic drugs on newly treated patients with type2 diabetes |
| Date of disclosure of the study information | 2012/01/04 |
| Last modified on | 2017/07/04 10:00:16 |
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Basic information
Public title
A clinical study of the correlation between QOL and the effects of oral anti-diabetic drugs on newly treated patients with type2 diabetes
Acronym
A clinical study of the correlation between QOL and the effects of oral anti-diabetic drugs on newly treated patients with type2 diabetes
Scientific Title
A clinical study of the correlation between QOL and the effects of oral anti-diabetic drugs on newly treated patients with type2 diabetes
Scientific Title:Acronym
A clinical study of the correlation between QOL and the effects of oral anti-diabetic drugs on newly treated patients with type2 diabetes
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine which oral anti-diabetic drug is the most effective in improving QOL of patients with type2 diabetes who are newly treated with anti-diabetic drugs, using a new designed questionnaire named OHA-Q (Oral Hypoglycemic Agent Questionnaire)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores in QOL questionnaire at 4th week
Key secondary outcomes
Scores in QOL questionnaire at 12th week
Analyses of each item score in the questionnaire for each drug
Analyses of intra-class correlation in the questionnaire for each drug
The changing rate of HbA1c for each drug
Completion rate for each drug treatment
Patient adherence to each drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1 taking single administration of DPP-4 inhibitor
Start with the basic dose determined by each clinic
Changing dose and administration should be determined by the doctor in charge
Treatment period is 12weeks
Interventions/Control_2
Group 2 taking single administration of a-I
Start with the basic dose determind by each clinic
Changing dose and administration should be determind by the doctor in charge
Treatment period is 12 weeks
Interventions/Control_3
Group 3 taking single administration of SU
Start with the basic dose determind by each clinic
Changing dose and administration should be determined by the doctor in charge
Treatment period is 12 weeks
Interventions/Control_4
Group 4 taking single administration of BG
Start with the basic dose determined by each clinic
Changing dose and administration should be determined by the doctor in charge
Treatment period is 12weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Newly treated with any oral anti-diabetic drugs and inadequate glycemic control(HbA1c 6.5-9.0%[the JDS]/6.9-9.4%6.9-9.4%[the NGSP] in spite of diet and exercise therapy for over 4 weeks
2)Age of 20<=, 80>
3)Out patients of either gender
4)Patients who agree to participate in the study, and who are able to start in 12 weeks
Key exclusion criteria
1)type1 diabetes(CPR blood test and anti-GAD test is recommended)
2)Taking any anti-diabetic drugs
3)Severe ketosis, precoma, diabetic coma
4)Hepatic dysfunction(ALT <= 3times the upper limit of normal)
5)Gastrointestinal dysfunction as diarrhea or vomiting
6)Severe infection, severe injury. Before and after accepting surgery
7)Pregnant or suspected to be pregnant
8)History of hypersensitivity to any component of testing drugs
9)History of cancer or being treated for cancer
10)Whom the doctor in charge decided not to be appropriate for this study on the point of medical reason
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ishii |
Organization
Nara Medical University
Division name
Department of Diabetology
Zip code
Address
840, Shijocho, Kashihara-shi, Nara
TEL
0744223051
dmqol@inc-re.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | QOL study group for oral anti-diabetic agent secretariat |
Organization
RE Co., Ltd.
Division name
RE Co., Ltd.
Zip code
Address
4F, HoeiFchu Bldg. 2-10-3 Kotobukicho, Fuchu-shi, Tokyo, 183-0056, Japan
TEL
042-367-2306
Homepage URL
http://dm-qol.jimdo.com/
dmqol@inc-re.com
Sponsor or person
Institute
QOL study group for oral anti-diabetic agent
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2012 | Year | 01 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 07 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 29 | Day |
Last modified on
| 2017 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008241
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