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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006959
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Department of Metabolism and Endocrinology, Juntendo Graduate University of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008167

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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