UMIN-CTR Clinical Trial

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

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan society for Patient Reported Outcome

Institute

Department

Personal name

Organization

Japan society for Patient Reported Outcome

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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