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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006088
Receipt No. 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

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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
Email 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
Email aimagawa@endmet.med.osaka-u.ac.jp

Sponsor
Institute Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007175

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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