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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005202
Receipt No. R000006179
Scientific Title The effective switch from intensive insulin therapy to the once-daily human GLP-1 analogue liraglutide in patients with fairly well controlled type 2 diabetes
Date of disclosure of the study information 2011/03/08
Last modified on 2011/03/06

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Basic information
Public title The effective switch from intensive insulin therapy to the once-daily human GLP-1 analogue liraglutide in patients with fairly well controlled type 2 diabetes
Acronym The effective switch from intensive insulin therapy to the once-daily human GLP-1 analogue liraglutide in patients with fairly well controlled type 2 diabetes
Scientific Title The effective switch from intensive insulin therapy to the once-daily human GLP-1 analogue liraglutide in patients with fairly well controlled type 2 diabetes
Scientific Title:Acronym The effective switch from intensive insulin therapy to the once-daily human GLP-1 analogue liraglutide in patients with fairly well controlled type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of the change to liraglutide from intensive insulin therapy in type 2 diabetic patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the parameters related to glucose profile of the subjects and proinsulin to C-peptide ratio before and after switching
Key secondary outcomes Diabetes treatment satisfaction questionnaire (DTSQ), Frequency of side effects (digestive symptoms, hypoglycemia)

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intensive insulin therapy administered by fourth-daily insulin injections was discontinued and we changed it for treatment in liraglutide alone and gradually increased clinical dosage according to the attached document.
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria were adequate endogenous insulin secretion (urinary C-peptide > 40 microgram/day) and controlled HbA1c levels of <= 7.5% on intensive insulin therapy with insulin dose of < 30 units.
Key exclusion criteria 1, Subjects who have already been treated with oral hypoglycemic agents.
2, Subjects who are hypersensitive to this medicine and/or contaminants of this medicine.
3, Any condition that the investigator considers a potential obstacle to trial participation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taisuke Kikuchi
Organization Kanto Rosai Hospital
Division name Department of Diabetes and Endocrinology
Zip code
Address 1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL 044-411-3131
Email

Public contact
Name of contact person
1st name
Middle name
Last name Taisuke Kikuchi
Organization Kanto Rosai Hospital
Division name Department of Diabetes and Endocrinology
Zip code
Address 1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL
Homepage URL
Email taisukekikuchi@kantoh.rofuku.go.jp

Sponsor
Institute Department of Diabetes and Endocrinology, Kanto Rosai Hospital
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 08 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 Enrolling by invitation
Date of protocol fixation
2010 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 06 Day
Last modified on
2011 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006179

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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