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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007159
Receipt No. R000008435
Scientific Title Patient's Psychological Attitude and Glycemic control Effectiveness by GLP-1 (PAGE-1)
Date of disclosure of the study information 2012/01/30
Last modified on 2014/03/28

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Basic information
Public title Patient's Psychological Attitude and Glycemic control Effectiveness by GLP-1 (PAGE-1)
Acronym Patient's Psychological Attitude and Glycemic control Effectiveness by GLP-1 (PAGE-1)
Scientific Title Patient's Psychological Attitude and Glycemic control Effectiveness by GLP-1 (PAGE-1)
Scientific Title:Acronym Patient's Psychological Attitude and Glycemic control Effectiveness by GLP-1 (PAGE-1)
Region
Japan

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

Objectives
Narrative objectives1 This clinical study investigates the effects on a patient's QOL and the effectiveness of a GLP-1 receptor agonist (liraglutide), which is expected to resolve or reduce unmet needs as well as improve satisfaction with diabetes treatment, in patients with type 2 diabetes who start diabetes treatment with liraglutide, by observing changes in the QOL, association of these changes with glycemic control, and changes in patients' awareness of diabetes treatment and the drug to be studied immediately before (Week 0) and 12 weeks after treatment initiation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Variation in QOL scores based on DTR-QOL
2. Correlation of the changes in HbAlc with those of DTR-QOL scores
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who start treatment with liraglutide (those determined to undergo treatment with liraglutide) within the limits of coverage by health insurance) and have received pretreatment with:
(1) Only diet and exercise therapies
(2) In addition to diet and exercise therapies, sulfonylurea agents
2) Male and female patients aged 15 years or older
3) Patients who have agreed to participate in this study.
Key exclusion criteria 1) Patients not prescribed liraglutide in accordance with the recommendations by the "Committee on the proper use of incretins (GLP-1 receptor agonists and DPP-4 inhibitors)"
2) Patients with previous or current treatment with insulin formulations
3) Patients receiving previous treatment with GLP-1 receptor agonists
4) Patients with hypersensitivity to this drug or excipient
5) Female patients being pregnant/breast-feeding or desiring to become pregnant within the next 12 months
6) Patients with malignancies
7) Patients meeting the contraindications for GLP-1 receptor agonist (18 mg Victoza; subcutaneous injection) (liraglutide)
8) Patients with severe complications resulting from diabetes or other causes
9) Other patients determined ineligible by an investigator
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi ISHII
Organization Tenri Hospital
Division name Department of Endocrinology
Zip code
Address 200, Mishima-cho, Tenri-shi, Nara
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Page-1 study support center
Division name Soiken Inc. Clinical trials support
Zip code
Address NFB Ogawa-cho Bldg 4F, 1-3-1, Kanda Ogawa-cho, Chiyoda-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Japan society for Patient Reported Outcome
Institute
Department

Funding Source
Organization Japan society for Patient Reported Outcome
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 01 Month 30 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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This clinical study investigates the effects on a patient's QOL and the effectiveness of a GLP-1 receptor agonist (liraglutide), which is expected to resolve or reduce unmet needs as well as improve satisfaction with diabetes treatment, in patients with type 2 diabetes who start diabetes treatment with liraglutide, by observing changes in the QOL, association of these changes with glycemic control, and changes in patients' awareness of diabetes treatment and the drug to be studied immediately before (Week 0) and 12 weeks after treatment initiation.

Management information
Registered date
2012 Year 01 Month 30 Day
Last modified on
2014 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008435

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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