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BOSTON — Treatment with a once-daily, single-injection combination of insulin degludec and liraglutide (IDegLira), as compared with insulin glargine, lowered HbA1c levels, decreased body weight and reduced the risk for hypoglycemia in patients with type 2 diabetes, according to data from the DUAL V trial presented at the American Diabetes Association (ADA) 75th Scientific Sessions.
“The important thing about the DUAL V study is that it’s the first comparison of IDegLira to a basal insulin in patients who had failed basal insulin therapy allowing for unlimited titration. This addresses a very large segment of the population with inadequately controlled diabetes in the United States,” John B. Buse, MD, PhD, of the University of North Carolina School of Medicine in Chapel Hill, said during a presentation.
Buse and colleagues conducted a 26-week, open-label trial comparing the efficacy and safety of IDegLira to insulin glargine in patients with type 2 diabetes that was uncontrolled on insulin glargine (20 U to 50 U).
In the DUAL V trial, the researchers randomly assigned 557 adults with mean HbA1c levels between 7% and 10% to IDegLira daily (n=278) or continued insulin glargine uptitration (n=279). All patients were also on metformin.
Initial doses were 16 dose steps — 16 U of insulin degludec plus liraglutide 0.6 mg for the IDegLira group, with a maximum of 50 dose steps. Mean pre-trial dose for the insulin glargine group was 32 U, with no maximum. Fasting self-measured blood glucose titration target was 71 mg/dL to 90 mg/dL in both groups.
Baseline characteristics were well balanced between groups, Buse said. Patients were aged slightly younger than 60 years, with a BMI around 32 and a duration of diabetes of about 11 to 12 years. HbA1c was 8.4% in the IDegLira group and 8.2% in the insulin glargine group.
The primary endpoint was change in HbA1c over time. At 26 weeks, patients receiving IDegLira achieved a significant 1.8% reduction in HbA1c (declining from 8.4% at baseline to 6.6%), as compared with a 1.1% reduction (declining from 8.2% at baseline to 7.1%) among those who increased their dose of insulin glargine (P<.001).
Mean fasting plasma glucose was similar in both groups, decreasing from 160 mg/dL to 110 mg/dL, according to the data.
Changes in weight loss, however, were significantly different between those on IDegLira and those on insulin glargine.
In the IDegLira group, mean weight decreased from 88.3 kg at baseline to 86.9 kg, whereas patients in the insulin glargine arm experienced a weight increase from 87.3 kg to 89.1 kg during the study.
Over the first 8 to 10 weeks, daily insulin titrated relatively rapidly in both study arms, Buse said. After this period, however, in the IDegLira arm, the dose was relatively stable at 41 U of insulin degludec vs. 66 U in the insulin glargine group.
There were significantly fewer cases of confirmed hypoglycemia in the IDegLira group compared with the insulin degludec group (79 vs. 137) as well as fewer cases of nocturnal hypoglycemia (17 vs. 68).
Results also revealed that the percentage of patients who achieved HbA1c levels of less than 7% were significantly higher in the IDegLira group than in the insulin glargine group (71.6% vs. 47.0%; P<.001).
Moreover, the percentage of patients achieving HbA1c levels of less than 7% without hypoglycemia was 54.3% in the IDegLira arm vs. 29.4% in the insulin glargine arm.
The researchers also assessed quality of life using the Short Form (36) Health Survey and found a statistically significant benefit with IDegLira for the physical component, but there was also a general trend across the board for better responses with IDegLira vs. insulin glargine.
Overall, adverse events as well as serious adverse event rates were similar in both treatment arms. Completion rates were high, with 90% completion for the IDegLira arm and 95% completion for the insulin glargine arm.
Buse acknowledged some limitations, including unmasked treatments and a maximum of 50 U of insulin glargine at randomization.
“There was a superior reduction in HbA1c at 26 weeks with IDegLira, and there was no loss of glycemic control when transferring from 20 U to 50 U of insulin glargine to 16 dose steps of IDegLira,” Buse said.
“IDegLira was also associated with weight loss while further titration of insulin glargine was associated with weight gain. IDegLira was superior to insulin glargine in terms of lower rate of confirmed hypoglycemic events, and there were no apparent or unexpected safety and tolerability issues for IDegLira, although more patients withdrew from IDegLira treatment.”
Reference
- Buse JB et al. Abstract 166-OR: Insulin Degludec/Liraglutide (IDegLira) Is Superior to Insulin Glargine (IG) in A1c Reduction, Risk of Hypoglycemia, and Weight Change: DUAL V Study. Presented at: American Diabetes Association (ADA) 75th Scientific Sessions; June 5-9, 2015; Boston.
