UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005202 |
|---|---|
| Receipt number | 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 16:20:12 |
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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
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
taisukekikuchi@kantoh.rofuku.go.jp
Sponsor or person
Institute
Department of Diabetes and Endocrinology, Kanto Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
