Clinical assessment of possible associations between long-term glucose-lowering effects of liraglutide and basal insulin combination therapy and remaining beta-cell functio

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000028374
• Lead Sponsor: Kansai Electric Power Medical Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified