UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007097 |
|---|---|
| Receipt number | R000008357 |
| Scientific Title | Comparison of the Effect of GLP-1 Receptor Agonists on Diurnal Glycemic Profiles in Patients with Diabetes |
| Date of disclosure of the study information | 2012/01/18 |
| Last modified on | 2013/03/28 19:03:04 |
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Basic information
Public title
Comparison of the Effect of GLP-1 Receptor Agonists on Diurnal Glycemic Profiles in Patients with Diabetes
Acronym
Comparison of Liraglutide and Exenatide Evaluated by CGM
Scientific Title
Comparison of the Effect of GLP-1 Receptor Agonists on Diurnal Glycemic Profiles in Patients with Diabetes
Scientific Title:Acronym
Comparison of Liraglutide and Exenatide Evaluated by CGM
Region
| Japan |
Condition
Condition
Insulin-independent Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to investigate the difference of the two distinct GLP-1 receptor agonists, liraglutide and exenatide on diurnal glycemic profiles evaluated by continuous glucose-monitoring (CGM) in patients with insulin-independent diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diurnal glycemic profiles, C-peptide- and glucagon-response to the meal test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
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 and exenatide are subcutaneously injected continuous 2 days for each as a cross-over manner and diurnal glycemic profiles are evaluated by CGM. Additionally, C-peptide- and glucagon-response to the meal test are examined before and after the administration of GLP-1 receptor agonists.
Interventions/Control_2
Exenatide and liraglutide are subcutaneously injected continuous 2 days for each as a cross-over manner and diurnal glycemic profiles are evaluated by CGM. Additionally, C-peptide- and glucagon-response to the meal test are examined before and after the administration of GLP-1 receptor agonists.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patients with diabetes who are in hospital for glycemic control.
2.Insulin-independency needs to be confirmed in those who are undergone insulin therapy.
3.The patients who have agreed to participate in this study with an informed consent.
Key exclusion criteria
1.The patients with serious complications
2.The patients who did not agree with this study
3.The patients with chronic kidney disease higher than stage 4
4.The patients with type 1 diabetes
5.Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hamamoto |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
06-6312-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
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
北野病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | 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 | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 18 | Day |
Last modified on
| 2013 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008357
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| Registered date | File name |
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| Registered date | File name |
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