• Hyperglycemia/Hypoglycemia
• Diabetes & Endocrinology Clinical Trials
• Diabetes Mellitus

• Hyperglycemia/Hypoglycemia
• Diabetes & Endocrinology Clinical Trials
• Endocrinology
• Diabetes & Metabolic Syndrome
• Diabetes Mellitus

Glucagon-like peptide 1 agonists have been shown to improve glycemic control and reduce the risk of weight gain and hypoglycemia, but some patients have gastrointestinal (GI) side effects. Basal insulin offers glycemic control even while fasting and allows for individualized dosing but increases the risk of hypoglycemia and weight gain. Combining these 2 agents has many potential advantages, such as improving glycemic control and reducing weight gain, while also reducing the risk of hypoglycemia or GI side effects seen when either agent is used as monotherapy. IDegLira is one such agent and contains a fixed-ratio combination of insulin degludec (IDeg) and liraglutide. The drug contains 0.036 mg of liraglutide for every 1 unit of IDeg.

Stephen C. L. Gough, MD, Oxford Centre for Diabetes, Endocrinology, and Metabolism, Oxford, United Kingdom, discussed 1-year safety and efficacy data from the phase 3, open-label Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes [DUAL I; Gough SCL et al. Lancet Diabetes Endocrinol. 2014].

Patients were randomly assigned 2:1:1 to IDegLira (n = 834), IDeg (n = 414), or liraglutide (n = 415). Baseline characteristics were similar for all groups. The average age was 55 years; body mass index was about 31 kg/m²; HbA_1c was 8.3%; and fasting plasma glucose (FPG) was about 9 mmol/L.

HbA_1c was lower in the patients treated with IDegLira (6.4%) when compared with either the IDeg group (6.9%) or the liraglutide group (7.0%) at week 26 (P < .001 for IDegLira vs both other treatments). These reductions were maintained at 52 weeks (HbA_1c = 6.4%, 6.9%, and 7.1%, respectively; P < .001 for IDegLira vs both other treatments). The percentages of patients whose HbA_1c were < 7% or ≤ 6.5% at the end of weeks 26 and 52 were significantly greater in the group treated with IDegLira than in those treated with IDeg or liraglutide (P < .0001, all).

The decrease in FGP was similar in the IDegLira and IDeg groups (−3.6 mmol/L) and significantly lower when compared with the liraglutide group (−1.75 mmol/L) at 26 weeks (P < .001). These decreases were maintained at 52 weeks, when FPG was 5.7, 6.0, and 7.3 mmol/L, respectively. At both 26 and 52 weeks, confirmed hypoglycemia was lowest with liraglutide and highest with IDeg, although rates were low overall. There was a slight increase in weight with IDeg, a decrease with liraglutide, and a slight but significant decrease with IDegLira when compared with either treatment (P < .001).

The rates of nausea in patients receiving IDeg and IDegLira were generally lower than they were for liraglutide. Other adverse events were similar across groups, and those for patients taking IDegLira were as expected for the individual components.

In conclusion, the DUAL I study showed that IDegLira was associated with significantly greater reductions in HbA_1c, significantly lower risk of hypoglycemia, and no weight gain as compared with IDeg at 52 weeks. When compared with liraglutide, IDegLira had greater reductions in HbA_1c and FPG while resulting in fewer GI adverse events. These data provide further support for the long-term safety and sustainability of the glucose-lowering effect of IDegLira.

• © 2014 MD Conference Express®