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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010769
Receipt No. R000012591
Scientific Title Glargine plus Lixisenatide or vildagliptin succeeding to BOT T2DM control evaluation trial in Kobe
Date of disclosure of the study information 2013/06/15
Last modified on 2019/12/09

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Basic information
Public title Glargine plus Lixisenatide or vildagliptin succeeding to BOT T2DM control evaluation trial in Kobe

Acronym GLP-ONE KOBE study
Scientific Title Glargine plus Lixisenatide or vildagliptin succeeding to BOT T2DM control evaluation trial in Kobe

Scientific Title:Acronym GLP-ONE KOBE study
Region
Japan

Condition
Condition T2DM
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison in the improvement of Blood Glucose control
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of HbA1c
Improvement daily BG profile
Key secondary outcomes

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 Basal Insulin+Lixisenatide

Interventions/Control_2 Basal Insulin+vildagliptin
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Sub-optimal controlled T2DM treated with basal insulin and Sitagliption (-/+ oher OHA)(HbA1c 7%-10%))
Key exclusion criteria Renal or Liver dysfunction
Pregnant or breast-feeding women
Slowly progressive T1DM
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Sakaguchi
Middle name
Last name kazuhiko
Organization Kobe University Graduate school of medicine
Division name diabetes and endocrinology
Zip code 650-0017
Address Kusunoki-cho, Chioku, Kobe
TEL 078-382-5861
Email kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Sakaguchi
Middle name
Last name kazuhiko
Organization Kobe University Graduate school of medicine
Division name diabetes and endocrinology
Zip code 650-0017
Address Kusunoki-cho, Chioku, Kobe
TEL 078-382-5861
Homepage URL
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate school of medicine
diabetes and endocrinology
Institute
Department

Funding Source
Organization Donation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Kobe University Hospital
Address 7-5-1, Kusunoiki-Cho, Chuoku, Kobe
Tel 078-382-6669
Email chiken@med.kobe-u.ac.jp

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
2013 Year 06 Month 15 Day

Related information
URL releasing protocol none
Publication of results Published

Result
URL related to results and publications none
Number of participants that the trial has enrolled 48
Results
HbA1c decreased equally, lixisenatide had the larger BW reduction effect than vildagliptin
Results date posted
2019 Year 12 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
T2DM patients, who were basal insulin user
Participant flow
RCT performed
Adverse events
serious adverse events none
Outcome measures
HbA1c BW etc
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 05 Month 13 Day
Date of IRB
2013 Year 05 Month 13 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 07 Month 31 Day
Date of closure to data entry
2015 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded
2016 Year 11 Month 21 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 20 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012591

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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