UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013222 |
|---|---|
| Receipt number | R000015431 |
| Scientific Title | Investigation of efficacy and safety of switching from basal-bolus therapy to combination therapy with GLP-1 receptor agonist and basal insulin injection in type 2 diabetes |
| Date of disclosure of the study information | 2014/02/22 |
| Last modified on | 2014/08/23 08:52:25 |
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Basic information
Public title
Investigation of efficacy and safety of switching from basal-bolus therapy to combination therapy with GLP-1 receptor agonist and basal insulin injection in type 2 diabetes
Acronym
JUN-LAN Study 9
Scientific Title
Investigation of efficacy and safety of switching from basal-bolus therapy to combination therapy with GLP-1 receptor agonist and basal insulin injection in type 2 diabetes
Scientific Title:Acronym
JUN-LAN Study 9
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of efficacy and safety of switching from basal-bolus therapy to combination therapy with GLP-1 receptor agonist and basal insulin injection in type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.MAGE by CGM
2.Glucose fluctuation by SMBG
Key secondary outcomes
1.change of C-peptide,glucagon and glucose during the meal test
2.frequency of hypoglycemia
3.frequency of adverse events
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
Type 2 diabetes treated with basal bolus therapy underwent CGM (day 1). After switching to combination therapy with GLP-1 receptor agonist and basal insulin, 10 and 20 microgram of GLP-1 receptor agonist were injected at day 2 and day3, 4. Dose of basal insulin was not changed.
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
1) FBS≤130mg/dl and 2hr postprandial glucose ≤ 250
2)Age≥ 20 years old
3)Male and female
Key exclusion criteria
1)hypersensitivity to lixisenatide
2)patient with hypoglycemia
3)patient with serious liver and kidney disease
4)patient with proiferatibe retinopathy
5)during pregnancy and lactation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
1-1, Hongo 3-chome, Bunkyo-ku, Tokyo
TEL
03-3813-3111
akana@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
1-1, Hongo 2-chome, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
akana@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
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
| 2014 | Year | 02 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
| 2014 | Year | 02 | Month | 22 | Day |
Last modified on
| 2014 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015431
