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Liraglutide, lifestyle changes reversed prediabetes; delayed onset of type 2 diabetes
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CHICAGO – Liraglutide, in conjunction with lifestyle changes, was superior to placebo in the reversal of prediabetes and in slowing the onset of type 2 diabetes in patients with overweight or obesity, according to a poster at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.
F. Xavier Pi-Sunyer, MD, MPH, of Columbia University, told Endocrine Today that the effect of the drug on the prevention of diabetes was significant. “The impact of the drug and the impact of the weight loss … had a large impact in preventing progression to diabetes,” he said.
F. Xavier Pi-Sunyer
In the SCALE study, a randomized, double blind, placebo-controlled trial, 3,731 subjects with overweight or obesity were given liraglutide 3 mg (n=2,432) once a day by injection or placebo (n=1,220) for 56 weeks. All patients were on a controlled diet, eating at least 500 fewer calories per day, and had at least one additional risk factor such as prediabetes, high blood pressure or high cholesterol. Dosages started at 0.6 mg and were titrated to the therapeutic dose to avoid adverse effects, according to the abstract.
By the end of the study period, those on medication had lost an average of 18.7 lbs (8% body weight), as compared to 6.2 lbs (2.6% body weight) for those on placebo. The primary endpoint of the study, which investigated liraglutide at a 3 mg dose, was weight loss. Liraglutide (Victoza, Novo Nordisk), an injectable drug that improves blood sugar, is marketed at a lower dose and not currently approved for weight control.
In addition to the weight-loss benefits seen, approximately 70% of patients with prediabetes on liraglutide normalized their glycemic measurements versus 32% those patients on placebo (estimated OR=4.85, P<.0001). In those participants who had normal blood sugar at the start of the study, more patients on placebo had progressed to prediabetes (19.9%) compared with those receiving the drug (6.9%; OR=3.3; P<.0001). Fasting plasma glucose, oral glucose tolerance curves and HbA1C levels improved, according to Pi-Sunyer.
“All of them were improved by taking the drug,” he said. “It was a highly significant difference between the people taking the drug vs. the people taking the placebo on these risk factors for diabetes control.”
After the initial 56-week trial period, some patients with prediabetes were re-randomized from liraglutide to placebo. A portion of these patients regained weight (2.9% vs. 0.7%) and progressed to prediabetes (22.4% vs. 8%, observed means). None of the patients progressed to type 2 diabetes.
The researchers concluded that in order to maintain results, patients would need to continue long-term treatment with liraglutide, and a 2-year extension is planned to observe subjects with prediabetes who are taking the drug. Twelve-week results currently show that those on liraglutide continue to maintain their weight loss, according to a press release.
“Overall, the drug had a very favorable effect on preventing diabetes in prediabetic individuals and in improving markers of glucose control in these individuals,” Pi-Sunyer said. —by Stephanie Arasim Portnoy, with additional reporting by Reagan Copeland
For More Information: Pi-Sunyer FX. Abstract SAT-0925. Presented at: The joint meeting of the International Congress of Endocrinology and the Endocrine Society; June 21-24, 2014; Chicago.
Disclosures: Pi-Sunyer is a medical advisory board member for Eisai, Johnson & Johnson, Novo Nordisk, Vivus USA, Weight Watchers and Zafgen.