The first study ever to test liraglutide in people with type 1 diabetes has found it to significantly lower mean fasting glucose and hemoglobin A1c, while cutting the need for insulin and causing significant weight loss.
The drug, a long-acting glucagon-like peptide-1 (GLP-1) analog, is currently approved only for type 2 diabetes and marketed under the brand name Victorza by Novo Nordisk.
But the senior author of the study, presented during the President’s Poster session at the 2011 American Diabetes Association meeting, said that he already prescribes the drug off-label to some of his patients to good effect.
“They have been amazed by the results,” said Paresh Dandona, MD, chief of endocrinology at the State University of New York at Buffalo. “Some patients even asked if we could increase the dose.”
An endocrinologist from Berlin, Germany, said she too has been using liraglutide off-label in her practice.
“I’m using it in everybody, and am happy with it,” said Dorothee Deiss, MD. “I go higher in the doses than were used in this study.”
Dr. Dandona said he decided to test the drug in people with type 1 diabetes because much of its effect is thought to be a suppression of glucagon release from the liver, which he reasoned could prove as beneficial as in people with type 2 diabetes.
The open-label study (abstract 411-PP) involved 28 patients with well-controlled type 1 diabetes who had a mean hemoglobin A1c of 6.5%. Half of the patients were treated with a single injection of liraglutide per day for a week, while the other half were treated for 24 weeks.
In the first week for all 28 patients, mean fasting glucose fell from 130 + 10 to 110 + 8 (p<0.05). Basal insulin fell from 25 + 6 to 17 + 6 units per day (p<0.05), while bolus insulin also fell significantly, from 23 + 4 to 16 + 4 (p<0.05).
Patients who continued on liraglutide for 24 weeks maintained similar improvements in glycemic control and also lost significant weight, dropping from a mean of 68.0 + 5 kg to 63.5 + 4 kg (p<0.05). Withdrawal of the drug resulted in a rapid reversal of the effects.
The study was supported by both the ADA and the National Institutes of Health. A larger randomized trial, testing 3 doses, will be funded by Novo Nordisk, Dr. Dandona said.