UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015201 |
|---|---|
| Receipt number | R000017670 |
| Scientific Title | Clinical Evaluation of Effects of Insulin-therapy or Liraglutide-therapy on Insulin Sensitivity in Type-2 Diabetes |
| Date of disclosure of the study information | 2014/09/18 |
| Last modified on | 2014/09/18 12:04:41 |
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Basic information
Public title
Clinical Evaluation of Effects of Insulin-therapy or Liraglutide-therapy on Insulin Sensitivity in Type-2 Diabetes
Acronym
Effects of Liraglutide or Insulin-therapy on Insulin Sensitivity
Scientific Title
Clinical Evaluation of Effects of Insulin-therapy or Liraglutide-therapy on Insulin Sensitivity in Type-2 Diabetes
Scientific Title:Acronym
Effects of Liraglutide or Insulin-therapy on Insulin Sensitivity
Region
| Japan |
Condition
Condition
Type-2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of improvement in insulin sensitivity by Liraglutide
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in Insulin sensitivity assessed by hyperinsulinemic-euglycemic clamp examination
Key secondary outcomes
We examine the correlated factors for the changes of insulin sensitivity.
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-therapy
Interventions/Control_2
Intensive insulin-therapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stable patients with type-2 DM who are already treated in the out-patients clinic of Jinnouchi Hospital.
HbA1c>=7.0%
capable of exercise-tharepy and diet-therapy
Key exclusion criteria
Type-1 DM
unstable condition in CVD
active inflammation
severe liver disease
dementia
CKD>=stage-4
disability in bed
cancer
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Jinnouchi |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
Address
2-3 6-chome Kuhonji, Chuo-ku Kumamoto city, Kumamoto Japan
TEL
096-363-0011
hideaki@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
Address
2-3 6-chome Kuhonji, Chuo-ku Kumamoto city, Kumamoto Japan
TEL
096-363-0011
Homepage URL
ssugiyam@kumamoto-u.ac.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Jinnouchi Hospital
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
陣内病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 18 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 18 | Day |
Last modified on
| 2014 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017670
