medwireNews: Adding liraglutide 3.0 mg to intensive behavioral therapy increases weight loss in overweight or obese people with insulin-treated type 2 diabetes, results of the phase 3 SCALE Insulin trial show.
Individuals who received liraglutide 3.0 mg also had “improved glycemic control despite lower doses of basal insulin and without increases in hypoglycemic events” relative to those who received placebo, W Timothy Garvey (The University of Alabama at Birmingham, USA) and co-authors report in Diabetes Care.
The researchers explain that although liraglutide 1.8 mg is approved for use in combination with insulin for diabetes treatment, the higher dose of 3.0 mg, which is an approved anti-obesity drug, has not previously been studied in this setting.
To address this, the international SCALE Insulin trial included 396 overweight or obese individuals with type 2 diabetes who were randomly assigned to receive daily subcutaneous liraglutide 3.0 mg (n=198) or placebo (n=198), each alongside intensive behavioral therapy. All study participants were already undergoing treatment with basal insulin and no more than two oral antidiabetic drugs.
After 56 weeks of treatment, mean weight loss was significantly greater among the individuals who received liraglutide than among those who received placebo, at 5.8% versus 1.5%, resulting in an estimated treatment difference of 4.3 percentage points.
Furthermore, patients receiving liraglutide 3.0 mg were a significant 3.41 times more likely to achieve a weight loss of at least 5% than those receiving placebo, at rates of 51.8% and 24.0%, respectively, at 56 weeks.
Liraglutide 3.0 mg was also associated with significantly greater reductions in mean waist circumference (5.28 vs 2.56 cm), glycated hemoglobin (HbA1c; 1.1 vs 0.6% [11.9 vs 6.0 mmol/mol]), and systolic blood pressure (5.6 vs 1.6 mmHg).
There was no significant difference between the two groups in mean fasting plasma glucose overall, but the researchers found that individuals receiving liraglutide 3.0 mg had significantly lower mean daytime glucose levels than those receiving placebo.
In addition, individuals receiving liraglutide required a significantly smaller increase in insulin dose to stay within glycemic target throughout the study compared with those receiving placebo, at a mean 3 versus 18 units.
Garvey and team report that no new safety signals were identified with liraglutide 3.0 mg, with similar adverse event rates reported between the people who received the study drug and those who received placebo (92.3 vs 88.8%). The only exception was for gastrointestinal events, which occurred in 62.1% of the liraglutide group and 46.7% of the placebo group.
Hypoglycemic episodes occurred in 71.8% (742.3 events per 100 patient–years) of individuals receiving liraglutide 3.0 mg and 71.1% (937.9 events per 100 patient–years) of those receiving placebo, with severe hypoglycemic event rates at 1.5% (1.5 events per 100 patient–years) and 1.0% (1.0 event per 100 patient–years), respectively.
The authors conclude: “Although treatment with insulin often results in weight gain, the extent to which the weight loss observed with liraglutide 3.0 mg in the present trial was the result of the direct action of liraglutide on feelings of hunger and satiety and possible delay in gastric emptying, or the result of indirectly reducing insulin requirements and use of [sulfonylureas], requires further investigation.”
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