Variables associated with HbA1c and weight reductions when adding liraglutide to multiple daily insulin injections in persons with type 2 diabetes (MDI Liraglutide trial 3)
Sofia Dahlqvist1, Elsa Ahlén1,2,3, Karin Filipsson4,5, Thomas Gustafsson6, Irl B Hirsch7, Jaakko Tuomilehto8,9,10, Henrik Imberg11,12, Bo Ahrén4, Stig Attvall3, Marcus Lind
 
Svensk studie av GLP-1-analog visar att  olika patientgrupper ofta svarar med förbättring i HbA1c respektive viktnedgång. Det var inget statistiskt samband mellan patienter som fick en stor sänkning i HbA1c och stor viktnedgång.
 
Patienter med bättre blodsocker vid start av terapi gick ner mer i vikt än de med sämre kontroll.
 
Studien indikerar att vårdgivare behöver utvärdera effekter på HbA1c och vikt  individualiserat och att det är svårt att definiera en ”responder”, dvs en patient som svarar på behandling, utifrån att effekt ska finnas både på vikt och HbA1c.
 
Studien är av betydelse då det i olika riktlinjer internationellt och nationellt ofta tagits upp som ett kriterium att en patient som svarar på behandling (responder) har effekt på både HbA1c och vikt.
 
Abstract
 
Objective 
To evaluate variables associated with hemoglobin A1c (HbA1c) and weight reduction when adding liraglutide to persons with type 2 diabetes treated with multiple daily insulin injections (MDI).
Research design and methods 
This was a reanalysis of a previous trial where 124 patients were enrolled in a double-blind, placebo-controlled, multicenter randomized trial carried out over 24 weeks. Predictors for effect on change in HbA1c and weight were analyzed within the treatment group and with concurrent interaction analyses. Correlation analyses for change in HbA1c and weight from baseline to week 24 were made.
 
Results 
The mean age at baseline was 63.7 years, 64.8% were men, the mean number of insulin injections was 4.4 per day, the mean daily insulin dose was 105 units and the mean HbA1c was 74.5 mmol/mol (9.0%). The mean HbA1c and weight reductions were 12.3 mmol/mol (1.13%; P<0.001) and 3.8 kg (P<0.001) greater in liraglutide than placebo-treated persons. There was no significant predictor for greater effect on HbA1c that existed in all analyses (univariate, multivariate and interaction analyses against controls). For a greater weight reduction when adding liraglutide, a lower HbA1c level at baseline was a predictor (liraglutide group P=0.002, P=0.020 for liraglutide group vs placebo). During follow-up in the liraglutide group, no significant correlation was found between change in weight and change in HbA1c (r=0.09, P=0.46), whereas a correlation existed between weight and insulin dose reduction (r=0.44, P<0.001).
 
Conclusion 
Weight reduction becomes greater when adding liraglutide in patients with type 2 diabetes treated with MDI who had a lower HbA1c level compared with those with a higher HbA1c level. There was no correlation between reductions in HbA1c and weight when liraglutide was added, that is, different patient groups responded with HbA1c and weight reductions.
 
Trial registration number EudraCT nr: 2012-001941-42.
 
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