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Abstract
Introduction
The effects of the GLP-1 analogue liraglutide on time in hypoglycaemia, time in hyperglycaemia, and time in range for type 2 diabetes patients initially treated with multiple daily insulin injections (MDI) were investigated. Variables associated with hypoglycaemia in the current population were also identified.
Methods
Analyses were based on data from a previously performed double-blind, placebo-controlled trial in which 124 MDI-treated patients with type 2 diabetes were randomized to liraglutide or placebo. Masked continuous glucose monitoring (CGM) was performed at baseline and week 24 in 99 participants.
Results
The mean time in hypoglycaemia was similar for participants receiving liraglutide and those receiving placebo after 24 weeks of treatment. Mean time in target was greater in the liraglutide group than in the placebo group: 430 versus 244 min/24 h (p < 0.001) and 960 versus 695 min/24 h (p < 0.001) for the two glycaemic ranges considered, 4–7 mmol/l and 4–10 mmol/l, respectively. Mean time in hyperglycaemia was lower in the liraglutide group: 457 versus 723 min/24 h (p = 0.001) and 134 versus 264 min/24 h (p = 0.023) for the two cutoffs considered, > 10 mmol/l and > 14 mmol/l, respectively. Lower mean glucose level, lower C-peptide, and higher glucose variability were associated with an increased risk of hypoglycaemia in both treatment groups. Higher proinsulin level was associated with a lower risk of hypoglycaemia in the liraglutide group.
Conclusion
For type 2 diabetes patients initially treated with MDI, introducing liraglutide had a beneficial effect on glucose profiles estimated by masked CGM. Mean glucose level, glycaemic variability, C-peptide, and proinsulin level influenced the risk of hypoglycaemia in this population.
Trial Registration
ClinicalTrials.gov, number (EudraCT nr: 2012-001941-42).
Funding
Novo Nordisk funded this study. The Diabetes Research Unit, NU-Hospital Group funded the journal’s Rapid Service Fee.
Details
; Imberg, Henrik 2 ; Ólafsdóttir, Arndís F 1 ; Ekelund, Magnus 3 ; Dahlqvist, Sofia 1 ; Hirsch, Irl 4 ; Filipsson, Karin 5 ; Ahrén, Bo 5 ; Sjöberg, Stefan 6 ; Jaako Tuomilehto 7 ; Lind, Marcus 1 1 Department of Medicine, NU-Hospital Group, Uddevalla, Sweden; Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
2 Statistiska Konsultgruppen, Gothenburg, Sweden; Department of Mathematical Sciences, Chalmers University of Technology and University of Gothenburg, Gothenburg, Sweden
3 Novo Nordisk A/S, Søborg, Denmark; Department of Clinical Sciences Lund, Lund University, Lund, Sweden
4 School of Medicine, University of Washington, Seattle, USA
5 Department of Clinical Sciences Lund, Lund University, Lund, Sweden
6 Department of Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden
7 Department of Public Health Solutions, National Institute for Health and Welfare, Helsinki, Finland; Department of Public Health, University of Helsinki, Helsinki, Finland; Diabetes Research Group, King Abdulaziz University, Jeddah, Saudi Arabia