New study of normal-weight patients suggests weight reduction, insulin requirements.
Adding liraglutide (Victoza, Novo Nordisk) to insulin in overweight adults with inadequately controlled type 1 diabetes does not improve glucose control compared with placebo. There has been minimal research conducted to examine the effects of liraglutide in normal-weight, poorly controlled T1DM patients. Therefore, researchers wanted to study the efficacy and safety of once-daily liraglutide 1.2mg vs. placebo as add-on to insulin treatment in this population.
Researchers conducted a randomized, double blind, placebo-controlled study with 40 patients who were diagnosed with T1DM (HbA1c greater than or equal to 8%). These subjects received liraglutide 1.2mg once daily or placebo for 12 weeks. Continuous glucose monitoring was performed at baseline and post treatment. Researchers measured efficacy by measuring HbA1c. Other parameters included change in insulin dose, weight, glycemic excursions, heart rate, and blood pressure.
It was found that at 12 weeks, HbA1c decreased from baseline by -0.6% in the liraglutide group vs. -0.5% in the placebo (P = 0.62). There were no significant differences in glycemic excursions in either group. Body weight decreased after 12 weeks in the liraglutide group (-3.13kg); whereas body weight increased in the placebo group (1.12kg) (P <0.0001). In the liraglutide group, there was significant decrease in bolus insulin at week 12 (from 27.4 IU/day to 23.6 IU/day) (P = 0.006). However, no change in bolus insulin was observed in the placebo group. There were no significant differences in either group for incidence of hypoglycemia; however, GI side effects were more prevalent in the liraglutide group.
Results at 24 weeks showed no significant difference between groups in change in HbA1c from baseline (between-group difference, –0.2%; P = .1833).
In the liraglutide group, the bolus insulin dose was 23.1% less than placebo (between group difference: –5.8 IU; p=0.0227). But after adjustment for body weight, no significant differences in insulin dosage existed at any time point.
Body weight fell by 6.4% in the liraglutide group, but remained unchanged with placebo (between group difference, –6.8 kg; P = .0145).
The liraglutide group experienced fewer hypoglycemic events than those participants in the placebo arm (736 vs 884, respectively; incident rate ratio, 0.82), and patients perceived a higher frequency of hypoglycemia with placebo (P = .0257).
Researchers concluded that “liraglutide 1.2mg once daily as add-on to insulin treatment in normal-weight, poorly controlled T1DM patients, without endogenous insulin secretion, has no significant effect on HbA1c, a minor but significant effect on the dose of bolus insulin, and induces a significant reduction in body weight with an incidence of hypoglycemia similar to placebo.”
- Liraglutide significantly reduces body weight and insulin requirements.
- Liraglutide has no significant effect on HbA1c in normal weight patients with T1DM inadequately controlled on insulin alone.
- The incidence of hypoglycemia remained similar in liraglutide and placebo groups; however, more GI adverse events were observed with liraglutide.
Frandsen, Christian S., et al. “Twelve-Week Treatment With Liraglutide As Add-On to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blinded Parallel Study.” Diabetes care (Oct 20, 2015): dc151037.