UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006959 |
|---|---|
| Receipt number | R000008167 |
| Scientific Title | The efficacy of GLP-1 receptor agonist on glycemic control in type 2 diabetes with inadequate DPP-4 inhibitor therapy. |
| Date of disclosure of the study information | 2012/01/31 |
| Last modified on | 2014/07/29 12:50:04 |
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Basic information
Public title
The efficacy of GLP-1 receptor agonist on glycemic control in type 2 diabetes with inadequate DPP-4 inhibitor therapy.
Acronym
Victoza on Inadequate Control with Sitagliptin in Juntendo and Toho
Scientific Title
The efficacy of GLP-1 receptor agonist on glycemic control in type 2 diabetes with inadequate DPP-4 inhibitor therapy.
Scientific Title:Acronym
Victoza on Inadequate Control with Sitagliptin in Juntendo and Toho
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 GLP-1receptor agonist in type 2 diabetes patients with inadequate glycemic control with DPP4 inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean change of glycated hemoglobin from baseline to after 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
lilaglutide 0.9mg/day sc
Interventions/Control_2
lilaglutide 0.3mg/day sc
In case with inadequate control after 3 months therapy with 0.3mg of lilaglutide, dose has to be increased to 0.9mg/day.
Interventions/Control_3
50mg of sitagliptin p.o
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
Type 2 diabetes patients treated with DPP-4 inhibitor and
(1)their HbA1c is more than 7.5%
(2)thier duration of therapy with DPP-4 inhibitor is more than 6 months.
(3)who can understand and agree with informed consent.
Key exclusion criteria
1)patients who come under contraindicaion for GLP-1 receptor agonist.
2) patients who come under careful administration for GLP-1 receptor agonist
3)patients with cancer
4)anemic patients (Hb is less than 11g/dL)
5) patients with thrombocytepenia (Platelet count is less than 100000/mm3)
6) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy
7) patietns with serious infection, inflammation, or injuary. pre- or post- operative state
8) patients who are pregnant, hope to be pregnant, or are in lactation period
9) patients who are not applicable to this study judged by the medical doctor.
Target sample size
90
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 endocrinology and metabolism
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-48021479
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Junetedo University Hospital
Division name
Ethical comittee
Zip code
Address
TEL
03-5802-1584
Homepage URL
Sponsor or person
Institute
Department of Metabolism and Endocrinology, Juntendo Graduate University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Novo Nordisc Pharma
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 01 | Month | 31 | 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
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2014 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008167
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
