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Liraglutide preserves postprandial insulin secretion 1 year after diagnosis of type 1 diabetes
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SAN FRANCISCO — In patients with newly diagnosed type 1 diabetes, once-daily liraglutide 1.8 mg as an adjunct to insulin therapy preserved postprandial insulin secretion and reduced insulin dose requirements after 52 weeks of treatment compared with placebo, according to findings from the NewLira trial.
The effects disappeared 6 weeks after end of treatment, Thomas F. Dejgaard, MD, PhD, from Steno Diabetes Center, University of Copenhagen, Gentofte, Denmark, reported at the American Diabetes Association Scientific Sessions.
The randomized, double-blind, placebo-controlled, multicenter trial evaluated the efficacy of liraglutide (Victoza, Novo Nordisk) 1.8 mg once daily, compared with placebo, added to insulin therapy in adults with type 1 diabetes. The 68 patients randomized were newly diagnosed with type 1 diabetes within 6 weeks prior to the start of the study. The cohort was primarily male, mean age was 29.5 years, mean diabetes duration was 4.4 weeks, and mean fasting C-peptide was 112 pM in the liraglutide group and 107 pM in the placebo group.
At randomization, 52 weeks and 58-week follow-up, a liquid mixed-meal test (Boost, Nestle) was used to evaluate C-peptide response.
When the researchers examined glucose curves, there was no difference between groups at randomization, but a significantly lower level of postprandial glucose in the liraglutide group at 52 weeks (P = .04). This difference disappeared at 58-week follow-up. Due to the difference in postprandial glucose at end of treatment, Dejgaard said, the researchers decided to use, per protocol, the primary endpoint of area under the curve (AUC) for C-peptide over AUC for plasma glucose. When they examined this endpoint, there was no between-group difference at randomization, but a significant reduction in proportion of patients treated with placebo compared with liraglutide (44%; P = .04) that disappeared at the 58-week follow-up.
“Again, patients treated with liraglutide had significantly higher C-peptide volume 1 year after injection of liraglutide and 1 year after type 1 diabetes diagnosis,” Dejgaard said during his presentation.
The findings also revealed a significant reduction in total daily insulin dose among patients treated with liraglutide. At 52 weeks, there was almost 15% lower insulin use among patients assigned liraglutide compared with placebo, Dejgaard said. However, again, there was no difference at the 58-week follow-up.
Treatment did not result in changes in body weight, HbA1c or 7-point blood glucose profile.
In terms of safety, the incidence of self-reported, verified hypoglycemia was lower among the liraglutide group (1,860 events vs. 2,147 events; incidence rate ratio = 0.87; 95% CI, 0.82-0.93). No episodes of severe hypoglycemia or diabetic ketoacidosis occurred during the study, according to Dejgaard.
Adverse events were similar between the two groups. There was a higher rate of gastrointestinal events in the liraglutide group; most events were transient and mild to moderate, Dejgaard said. Five severe adverse events occurred during the study period, but none were related to liraglutide, he said.
“In these patients with newly diagnosed type 1 diabetes, liraglutide 1.8 mg as add-on to insulin after 52 weeks of treatment preserved postprandial insulin secretion compared with placebo, reduced insulin dose and events of self-monitored hypoglycemia ... and there were no changes in body weight, HbA1c or 7-point blood glucose profile,” Dejgaard concluded. – by Katie Kalvaitis
Reference:
Dejgaard TF, et al. 59-OR. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, San Francisco.
Disclosures: The study was funded by Novo Nordisk. Dejgaard reports he is a consultant for Novo Nordisk; receives research support from AstraZeneca and Novo Nordisk; and is on the speakers bureau for Boehringer Ingelheim.