UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010769 |
|---|---|
| Receipt number | 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 13:50:52 |
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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
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
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate school of medicine
diabetes and endocrinology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012591
