UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028374 |
|---|---|
| Receipt number | R000032482 |
| Scientific Title | Clinical assessment of possible associations between long-term glucose-lowering effects of liraglutide and basal insulin combination therapy and remaining beta-cell function |
| Date of disclosure of the study information | 2017/07/26 |
| Last modified on | 2018/01/25 11:55:09 |
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Basic information
Public title
Clinical assessment of possible associations between long-term glucose-lowering effects of liraglutide and basal insulin combination therapy and remaining beta-cell function
Acronym
Liraglutide/basal insulin combination and beta-cell function
Scientific Title
Clinical assessment of possible associations between long-term glucose-lowering effects of liraglutide and basal insulin combination therapy and remaining beta-cell function
Scientific Title:Acronym
Liraglutide/basal insulin combination and beta-cell function
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess potential relationship between beta-cell function, and the long-term durability of GLP-1 receptor agonist, liraglutide plus basal insulin in Japanese type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of remaining pancreatic beta-cell function between patients achieving HbA1c <7% by liraglutide/basal insulin combination therapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Key inclusion criteria
Patients with type 2 diabetes continuing basal insulin/liraglutide combination therapy for 54 weeks
Key exclusion criteria
1) Patients receiving an additional oral anti-diabetes drug or prandial insulin within 54 weeks after initiation of basal insulin and liraglutide combination therapy
2) Patients with with type 1 diabetes, pregnancy, pancreatic disease, liver disease, renal disease, or malignancy
3) Patients with severe renal failure (Ccr less than 30ml/min) and/or those taking dialysis
4) Patients receiving diabetogenic agents such as steroids
5) Patients with death within 54 weeks after initiation of basal insulin/liraglutide therapy
6) Patients with psychiatric disorders
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Yabe |
Organization
Kansai Electric Power Medical Research Institute
Division name
Yutaka Seino Distinguished Center for Diabetes Research
Zip code
Address
1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
078-303-6090
ydaisuke-kyoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Yabe |
Organization
Kansai Electric Power Medical Research Institute
Division name
Yutaka Seino Distinguished Center for Diabetes Research
Zip code
Address
1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
078-303-6090
Homepage URL
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kansai Electric Power Medical Research Institute
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
| 2017 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/jdi.12773/epdf
Number of participants that the trial has enrolled
Results
AIMS/INTRODUCTION:
The glucose-lowering effects of the glucagon-like peptide-1 receptor agonist, liraglutide, have been shown to rely on remaining beta-cell function. However, the possible associations of remaining beta-cell function with the glucose-lowering effects of liraglutide in combination with basal insulin remain unknown and warrant investigation.
MATERIALS AND METHODS:
This was a single-center, retrospective, observational study carried out in a private hospital in Osaka, Japan. Type 2 diabetes patients who received a prescription change from insulin therapy, both multiple-dose insulin and basal insulin-supported oral therapy, to liraglutide and basal insulin combination and continued the therapy for 54 weeks without additional oral antidiabetic drugs or bolus insulin were retrospectively analyzed.
RESULTS:
Among the 72 participants who received a prescription change from multiple-dose insulin and basal insulin-supported oral therapy to liraglutide and basal insulin combination, 57 continued the therapy for 54 weeks. Of those who continued the therapy without receiving additional oral antidiabetic drugs or bolus insulin, seven participants achieved glycated hemoglobin < 7.0% at 54 weeks, but 30 participants did not. The participants who achieved glycated hemoglobin < 7.0% at 54 weeks had a significantly higher C-peptide immunoreactivity index, a beta-cell function-related index frequently used in Japanese clinical settings. The receiver operating curve analysis showed that the C-peptide immunoreactivity index cut-off value for the achievement of glycated hemoglobin <7.0% at 54 weeks is 1.103.
CONCLUSIONS:
The current findings show that the glucose-lowering effects of liraglutide rely on remaining beta-cell function, even when used with basal insulin; and suggest that liraglutide and basal insulin combination might require additional bolus insulin to fully compensate insulin insufficiency in individuals with reduced beta-cell function.
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | 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
Retrospective analysis of basal insulin and liraglutide combination therapy
Management information
Registered date
| 2017 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032482
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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