Adults with type 2 diabetes treated with Xultophy ® (Ideglira), a combination of swallowing insulin and liraglutidblood in the previous three months), a reduction in body weight and a lower rate of hypoglycemia compared to patients treated with insulin glargine, according to a new study in phase 3b.
The results of this study, called Dual ™ V, have been presented in the recent 75th edition of the annual scientific sessions of the American Diabetes Association (ADA) in Boston.This is a 26-week trial that compared the effectiveness and safety of Xultophy® against insulin Glargina, both administered next to metformin, in patients with un controlled type 2 diabetes with glargine (20-50 units per day) .1
At 26 weeks, patients selected randomly for treatment with Xultophy ® achieved a statistically significant reduction in HBA1C of 1.8% compared to reference levels (8.4% to 6.6%) compared to comparisonA 1.1% reduction (8.2% to 7.1%) achieved by patients who increased their dose of insulin glargine (P&T 0.001) .1 in the group treated with Xultophy ®, 72% of patientsThey achieved an HBA1C of & LT; 7% at the end of the trial compared to 47% of the members of the Glargina Insulin Treated Group (p˂0.001) .1 In addition, 39% of patients treated with Xultophy ® achieved an HBA1C of& lt; 7% without hypoglycemia or weight gain compared to 12% of glargine treaties (P&T 0.001) .1
"These results show that Ideglira could have a positive impact on patients who are not controlled in their current treatment with basal insulin," said Professor John Bus, of the North Carolina University of Carolina University.Patients treated with IDGLIRA achieved an average HBA1C at the end of the 6.6%study, while experiencing a reduction in their weight and a significantly lower number of hypoglycemia episodes than patients to whom higher doses of insulin were administeredGlargina ”.
The confirmed hypoglycemia rate was 57% lower with Xultophy ® with respect to insulin glargine (2.23 episodes per patient per year versus 5.05; P&T 0.001) .1 There was also a significant difference of 3.2 kg in the changeof the body weight between the treatment groups (P&T 0.001): the weight was reduced 1.4 kg from the reference levels in patients treated with Xultophy® and increased 1.8 kg in the treaties with glargina.1 In addition,Patients treated with Xultophy ® required a significantly smaller amount of insulin than glargine treaties: 41 swallowing insulin units included in Xultophy ® at the end of the versus 66 units test respectively (P&R 0.001).
About Xultophy ®
Xultophy ® is a combination of Tresiba ® (insulin swallow), an analogous of basal insulin administered once a day with an ultralarga duration of action, and Victoza ® (liraglutida), a human analogue of LPG-1 administered once a day.Xultophy® is administered once a day with a single injection.The maximum dose number of Xultophy ® is 50, equivalent to 50 insulin outlet units and 1.8 mg of liraglutida.Xultophy ® is being investigated in the Dual ™ clinical trial program, which includes two phase 3A and various studies in phase 3B, in which more than 3,500 people with type 2 diabetes participate. Xultophy® received the authorization of the European Commissionfor commercialization on September 18, 2014.
Characteristics of xultophy® Link