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No HbA1c improvement for adults with type 1 diabetes assigned liraglutide
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Adults with type 1 diabetes, overweight and poor glycemic control randomly assigned liraglutide plus insulin therapy saw a reduction in hypoglycemia risk, insulin dose and clinically significant weight loss, but no reduction in HbA1c vs. those assigned insulin plus placebo, according to research in The Lancet Diabetes & Endocrinology.
Thomas Fremming Dejgaard, MD, of the Steno Diabetes Center in Gentofte, Denmark, and colleagues analyzed data from 100 adults with type 1 diabetes, a BMI more than 25 kg/m² and an HbA1c more than 8%. Those on insulin pump therapy were excluded from the study. Between July 2012 and May 2014, researchers randomly assigned participants to either once-daily liraglutide injection (Novo Nordisk; beginning at 0.6 mg, gradually increasing weekly to 1.8 mg per day) plus regular insulin therapy (n = 50; 30 men; mean age, 47 years; 100% white; mean HbA1c, 8.7%) or placebo (saline solution) plus insulin therapy (n = 50; 35 men; mean age, 49 years; 100% white; mean HbA1c, 8.7%) for 24 weeks. Researchers reduced basal and bolus insulin doses before randomization to reduce hypoglycemia; participants were not allowed to change insulin type during the study period. Participants visited the study center at baseline and weeks 3, 12, 23 and 24, and wore a masked continuous glucose monitor at baseline, week 12 and week 23 for 6 consecutive days.
After 12 weeks of treatment, researchers found that participants assigned liraglutide experienced a significant reduction in HbA1c vs. those assigned placebo (8.1% vs. 8.5%); however, that between-group difference was no longer statistically significant at 24 weeks of treatment (8.2% vs. 8.4%).
Participants assigned liraglutide also experienced fewer verified hypoglycemic episodes vs. those assigned placebo (736 events vs. 884 events), but during continuous glucose monitoring periods, researchers did not observe significant differences between groups for time spent in hypoglycemia or hyperglycemia.
Researchers observed a decrease in body weight for the liraglutide group at 24 weeks, whereas weight remained unchanged in the placebo group (between-group difference, –6.8 kg; 95% CI, –12.2 to –1.4).
Basal insulin doses were significantly lower in the liraglutide group at 24 weeks, with a between-group difference of 16.5%. Fasting plasma glucose values were similar between groups throughout the study period. Systolic blood pressure decreased in the liraglutide group but did not change for those assigned placebo (125 mm Hg vs. 130 mm Hg), whereas ambulatory heart rate for those assigned liraglutide increased from baseline to week 24 (80 bpm vs. 72 bpm). There were no between-group differences for LDL or HDL cholesterol.
Gastrointestinal adverse events were more common in the liraglutide group (45 events vs. 23 events); five severe adverse events occurred (three in the liraglutide group), including one case of severe hypoglycemia in the placebo group.
The researchers noted that the similar effect on HbA1c in the two groups may be a result of study design, as participants’ blood glucose levels were targeted in accordance with clinical guidelines, without the intensive monitoring done in a classic target-to-treat design.
“Because the improvements in HbA1c seen with the addition of liraglutide to insulin is similar to that seen with insulin alone, and because treatment with liraglutide is associated with additional expense, we cannot currently recommends combined treatment for the general population with type 1 diabetes,” the researchers wrote.
In commentary accompanying the study, David Simmons, MD, of Western Sydney University, wrote that study participants might have seen greater HbA1c improvements if using insulin pump therapy and if they completed a high-quality, structured diabetes education program.
“Overall, the results of the Lira-1 study show that ... liraglutide is likely to be a useful adjunct to insulin therapy and should be available for trial use in such patients,” Simmons wrote. “It is possible that greater benefit would be seen when patients have received validated structured education, with the addition of modern diabetes technology when needed, to minimize the risk for hypoglycemia.” – by Regina Schaffer
Disclosure: This study was funded by an unrestricted grant from Novo Nordisk. Dejgaard reports receiving lecture fees and research support from Novo Nordisk. Please see the full study for the other authors’ relevant financial disclosures.
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