UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010614 |
|---|---|
| Receipt number | 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 11:25:41 |
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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
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
kyasuda@noe.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Noe Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
