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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028374 |
Receipt No. | 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 |
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 |
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Condition | ||||
Condition | Type 2 diabetes | |||
Classification by specialty |
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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 | |
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Concealment |
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Eligibility | ||||
Age-lower limit |
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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 |
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Target sample size | 100 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Kansai Electric Power Medical Research Institute |
Institute | |
Department |
Funding Source | |
Organization | Kansai Electric Power Medical Research Institute |
Organization | |
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Category of Funding Organization | Profit organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Other administrative information | |||||||
Date of disclosure of the study information |
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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. |
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Recruitment status | Completed | ||||||
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Other | |
Other related information | Retrospective analysis of basal insulin and liraglutide combination therapy |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032482 |
Research Plan | |
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Research case data | |
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