UMIN-CTR Clinical Trial

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
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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
Email	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
Email	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
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
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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

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
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032482

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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