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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010614
Receipt No. R000011620
Scientific Title Efficacy of once daily human GLP-1 analogue, Liraglutide on dietary lifestyle and treatment satisfaction in type 2 diabetic patients.
Date of disclosure of the study information 2013/05/01
Last modified on 2014/02/13

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Basic information
Public title Efficacy of once daily human GLP-1 analogue, Liraglutide on dietary lifestyle and treatment satisfaction in type 2 diabetic patients.
Acronym Efficacy of Liraglutide on dietary lifestyle and treatment satisfaction
Scientific Title Efficacy of once daily human GLP-1 analogue, Liraglutide on dietary lifestyle and treatment satisfaction in type 2 diabetic patients.
Scientific Title:Acronym Efficacy of Liraglutide on dietary lifestyle and treatment satisfaction
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm efficacy of Liraglutide on dietary lifestyle and treatment satisfaction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in total calorie intake
Change in component of food (Protein, Fat, Carbohydrate)
Treatment satisfaction
Key secondary outcomes Change in HbA1c
Change in weight and BMI
Adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Liraglutide
Interventions/Control_2 Other diabetes standard oral treatment
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients who continue to visit to trial site for the treatment
Treated by diet & exercise therapy or diet & exercise therapy with oral anti-diabetic agents more than 3 months
Key exclusion criteria Contraindication of Liraglutide
Comorbidity of endocrine disease except diabetes.
Existence of severe diabetic complication like diabetic nephropathy severer than grade III by criteria of Japan Diabetes Society and diabetic retinopathy severer than by criteria of Japan Diabetes Society.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Yasuda
Organization Osaka Saiseikai Noe Hospital
Division name Department of diabetes and endocrinology
Zip code
Address 1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL 06-6932-0401
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Yasuda
Organization Osaka Saiseikai Noe Hospital
Division name Department of diabetes and endocrinology
Zip code
Address 1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL 06-6932-0401
Homepage URL
Email kyasuda@noe.saiseikai.or.jp

Sponsor
Institute Osaka Saiseikai Noe Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 大阪済生会野江病院(大阪府)
Osaka Saiseikai Noe Hospital, Osaka

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 01 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
2012 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
2013 Year 07 Month 31 Day
Date trial data considered complete
2013 Year 07 Month 31 Day
Date analysis concluded
2013 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 30 Day
Last modified on
2014 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011620

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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