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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006986
Receipt No. 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

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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
Email 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/
Email dmqol@inc-re.com

Sponsor
Institute QOL study group for oral anti-diabetic agent
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008241

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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