Published May 12, 2016
A study led by Paresh Dandona, MD, PhD, and published online in Diabetes Care shows overweight and obese Type 1 diabetics saw the most significant improvements — including a reduction in blood sugar — in a randomized clinical trial of liraglutide.
The 12-week study of 72 patients, 18 of whom received a placebo, found that adding liraglutide, an injectable medicine, 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 also saw a narrowing of blood-sugar swings and a reduction in systolic blood pressure.
The two highest doses of the drug in the study improved glucose control in overweight and obese patients, and because the drug suppresses appetite, it also produced an average weight loss of 11 pounds.
The weight loss and lower blood pressure findings are especially important, according to Dandona, since more than 40 percent of Type 1 diabetics have metabolic syndrome, a group of risk factors, including obesity and high blood pressure, 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, he says.
Liraglutide was developed, and is widely prescribed, to treat Type 2 diabetes. This study follows the researchers’ 2011 study, the first in this field, which found it had benefits in Type 1 diabetic patients.
“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,” says Nitesh Kuhadiya, MD, a former assistant professor of medicine, and first author on the paper.
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 says that means the best candidates are patients who are overweight and obese and who also have the worst-controlled diabetes (those with highest A1C).
The other important information arising out of the work is that liraglutide suppresses in a dose dependent fashion the increase in glucagon that occurs in diabetic patients after meals. This aspect is particularly important in terms of reducing unpredictable increases and oscillations in blood glucose, he says.
“Clearly more work needs to be done before the drug can be recommended for universal use in Type 1 diabetes,” Dandona says, “however there are thousands of Type 1 diabetics who have benefited from this treatment through participation in clinical trials around the globe.”
Dandona says 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,” he explains.
This can obscure the effect of the drug being tested, Dandona points 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 the study, Dandona adds 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 benefited significantly,” he says.
The study was funded by the Danish company Novo Nordisk, which manufactures liraglutide and markets it worldwide under the brand name Victoza.