UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007159 |
|---|---|
| Receipt number | 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 19:03:23 |
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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
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
Sponsor or person
Institute
Japan society for Patient Reported Outcome
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008435
