UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006088 |
|---|---|
| Receipt number | R000007175 |
| Scientific Title | Beta cell regeneration therapy for type 1 diabetes by GLP-1 receptor agonist and insulin |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2014/02/03 09:10:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Beta cell regeneration therapy for type 1 diabetes by GLP-1 receptor agonist and insulin
Acronym
Beta cell regeneration therapy for type 1 diabetes by GLP-1 receptor agonist and insulin
Scientific Title
Beta cell regeneration therapy for type 1 diabetes by GLP-1 receptor agonist and insulin
Scientific Title:Acronym
Beta cell regeneration therapy for type 1 diabetes by GLP-1 receptor agonist and insulin
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of human GLP-1 receptor agonist liraglutide to the pancreatic beta cell regeneration in Type 1 diabetes based on post-meal c-peptide AUC, c-peptide concentration after glucagon stimulation, glycemic control, and total daily insulin dosage as well as safety of liraglutide on this population.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Area under the curve of 2-hour serum C-peptide in mixed-meal test
Serum C-peptide levels by glucagon stimulation test
Key secondary outcomes
Glycated hemoglobin and glycated albumin
Total daily insulin dosage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Type 1 diabetes.
Liraglutide 0.9 mg/day (0.3 mg/day at the beginning and increased by 0.3 mg/day with one week interval up to 0.9 mg/day) .
The trial period is 24 months.
Throughout the trial period, insulin therapy to subjects will be continued.
Interventions/Control_2
Type 1 diabetes.(control)
The trial period is 24 months.
Throughout the trial period, insulin therapy to subjects will be continued.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Type 1 diabetes.
-Diagnosis of Type 1 diabetes is made by the criteria of the Japan Diabetes Society
-20-59 years of age
-Less than 2 years with type 1 diabetes
Key exclusion criteria
-History or presence of heart failure
-Presence of severe hepatic or/and renal dysfunction
-History or presence of alcoholic or severe infectious disease
-Pregnancy
-Other inappropriate patients judged by doctor
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihisa Imagawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2 Yamadaoka Suita Osaka JAPAN
TEL
06-6879-3732
aimagawa@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa Imagawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2 Yamadaoka Suita Osaka JAPAN
TEL
06-6879-3732
Homepage URL
aimagawa@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2014 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007175
