Release Date: April 11, 2016
BUFFALO, N.Y. – Overweight and obese Type 1 diabetics saw the most significant improvement in their blood sugar in a randomized clinical trial of liraglutide, an injectable medication, according to results published online in Diabetes Care on April 5.
Conducted by researchers at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, the exploratory study was funded by Novo-Nordisk, which manufactures liraglutide. The drug was developed, and is widely prescribed, to treat Type 2 diabetes. This study follows the researchers’ 2011 study, which found that liraglutide has some benefit for certain Type 1 diabetic patient populations.
The 12-week study of 72 patients, 18 of whom received a placebo, found that adding liraglutide, marketed as Victoza, to the insulin regimen of Type 1 diabetics resulted in what the study’s authors call “a modest reduction” of weekly mean glucose levels. They saw a narrowing of blood-sugar swings and a reduction in systolic blood pressure.
In overweight and obese patients, the two highest doses of the drug in the study improved glucose control and, because the drug suppresses appetite, too, produced an average 5-kilogram, or 11-pound, weight loss.
Paresh Dandona, MD, PhD is senior author on the paper and SUNY Distinguished Professor and chief of endocrinology, diabetes and metabolism in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. Nitesh Kuhadiya, MD, formerly assistant professor in the Department of Medicine, is first author.
“This was an exploratory study to examine the safety and efficacy of liraglutide in Type 1 diabetics and to determine which Type 1 diabetics are the best populations to study,” said Kuhadiya. “The study shows that the group treated with a 1.2 milligram dose of liraglutide who also had the highest body mass index and the highest hemoglobin A1C – average glucose control over a 90-day period – had the greatest benefit.”
Dandona added: “This study shows us that the best candidates are patients who are overweight and obese, and who also have the worst controlled diabetes, i.e., those with the highest A1C.”
The weight loss and lower blood pressure findings are especially important, he added, since more than 40 percent of Type 1 diabetics have metabolic syndrome, a group of risk factors, including certain kinds of weight gain, that raise an individual’s risk for developing cardiovascular disease and other chronic diseases. In addition to the induction of appetite suppression and weight loss in this study, liraglutide also suppressed glucagon in a dose dependent fashion; glucagon has a potent effect on raising glucose concentrations, Dandona said.
“Clearly more work needs to be done before the drug can be recommended for universal use in Type 1 diabetes,” said Dandona, “however there are thousands of Type 1 diabetics who have benefited from this treatment through participation in clinical trials around the globe.”
Dandona also pointed that one of the reasons for the results not being more significant is that in this clinical trial, as in most trials involving diabetics, all of the patients were put on continuous glucose monitoring. “Under continuous glucose monitoring, even the patients on placebo improve significantly through the constant supervision, teaching and guidance that is a main benefit of participating in a clinical trial,” Dandona explained.
This can obscure the effect of the drug being tested, he pointed out, adding that the most realistic way to study the drug’s effect will be when the drug is added to insulin treatment and compared without the additional guidance.
While noting the limitations of this study, Dandona added that he is currently leading additional trials of using liraglutide to treat Type 1 diabetics, funded by the National Institutes of Health and the Juvenile Diabetes Research Foundation.
“My overall impression after using liraglutide in the clinical and clinical trial setting is that the drug is efficacious and dozens of my patients have benefitted significantly,” he said.