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Recruitment status Completed
Unique ID issued by UMIN UMIN000015201
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email ssugiyam@kumamoto-u.ac.jp

Sponsor
Institute Jinnouchi Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017670


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