[ad_1]
SAN FRANCISCO – Liraglutide, a glucagon-like peptide-1 (GLP-1) agonist (Victoza, Novo Nordisk) taken daily with preserved postprandial insulin secretion for one year after diagnosis of type 1 diabetes in NewLira patients, while the effects disappeared six weeks after stopping treatment.
Thomas Dejgaard, MD, of the Steno Diabetes Center in Gentofte, Denmark, presented the work on June 8 here at the 2019 scientific sessions of the American Diabetes Association (ADA).
"After 52 weeks, in patients with newly diagnosed type 1 diabetes, we found that liraglutide 1.8 mg SC once a day was added to insulin, preserved the secretion of Postprandial insulin, reduced insulin dose and reduced cases of hypoglycemia compared with placebo No changes were observed in body weight, HbA1 C, or 7-point blood glucose profile, "he reported.
Moderator Uma Gunasekaran, MD, of the South Western Medical Center at the University of Texas at Dallas, commented on the work.
"There have been many studies over the years on the use of GLP-1 receptor agonists in type 1 diabetes. It's still a little promising but the impact It's not important enough, but what was really interesting here was the preservation of C-peptide levels and potentially the delay in the use of insulin, "she said.
In type 1 diabetes, GLP-1 agonists have shown a modest effect on glycemic control and insulin dose, and in peptide C positive patients, a greater reduction in HbA has been observed.1 C compared to C-peptide negative patients, explained Dejgaard, explaining the motivation of the study.
"In addition, lower rates of symptomatic hypoglycemia and very rare episodes of hyperglycemia with ketosis have been observed with GLP-1 agonist treatment. rodents suggest that GLP-1 agonists also increase beta cell mbad and prevent apoptosis of beta cells ". he added.
Peptide level C significantly higher with liraglutide after 1 year
In light of this basic research, the researchers decided to examine the effect of liraglutide on the residual function of beta cells as an insulin supplement treatment in patients with Recently diagnosed type 1 diabetes.
Patients had to be diagnosed with type 1 diabetes six weeks before the start of the study and were all between 18 and 40 years old. The level of C-peptide was evaluated post-prandially and should be ≥ 200 pmol / L.
A total of 68 patients were randomized (1: 1) to receive 1.8 mg of liraglutide plus insulin or placebo plus insulin for 52 weeks followed by 6 weeks on insulin alone. During randomization, end of treatment, and follow-up, a test was performed with the Boost Liquid Mixed Meal to evaluate the C-peptide response.
The patients were well matched, with a fasting C peptide of 100 pmol / L in both groups, almost all were antibody positive and the mean duration of diabetes was 4.5 weeks. Five patients discontinued treatment, including three in the liraglutide group.
The primary endpoint was the ratio of area under the curve (AUC) of peptide C divided by plasma glucose.
Patients randomized to receive liraglutide had a C AUC C peptide 44% higher than the placebo group (P = 0.04).
Six weeks after the end of the study (and discontinuation of liraglutide), this effect has disappeared.
"Patients treated with liraglutide had a significantly higher C-peptide value one year after diagnosis of type 1 diabetes compared to those on placebo," said Dejgaard.
Secondary endpoints included the daily dose of insulin required, body weight, self-controlled glucose profile, hypoglycemia and adverse effects.
Dejgaard noted a significant reduction in insulin dose in patients taking liraglutide by as much as 50%. During the treatment period, patients treated with liraglutide experienced a change in -9 IU compared to +12 IU in placebo-treated patients (P <0.001).
Again, six weeks after the end of liraglutide treatment, no difference was found.
There was no difference between the HbA groups1 C overall, but patients taking liraglutide had a lower HbA level1 C at 12 and 36 weeks. At the end of the treatment, there was no difference between the groups.
For body weight, liraglutide patients experienced a nonsignificant decrease shortly after the start of study treatment; However, overall, there was no difference between the groups.
"In fact, after 52 weeks, both groups increased their body weight," said Dejgaard.
(Patients with type 2 diabetes who take a GLP-1 agonist usually lose a little weight.In fact, liraglutide is also marketed as Saxenda for the treatment of obesity.)
Over a 58-week period, episodes of mild self-reported hypoglycemia (blood glucose <3.9 mmol / L) were 1860 events with liraglutide and 2147 events with placebo (P <0.05). There was no severe hypoglycemia.
"The other side effects were similar to those already known, such as nausea and dyspepsia, but in reality the nausea was quite high in patients treated with liraglutide, at almost 50%," said Dejgaard. "There were five serious adverse events, but none were badociated with the study drug, and there was no diabetic ketoacidosis."
But is there an added benefit for a GLP-1 agonist in type 1 diabetes?
"This is an important document because it confirms the data on dulaglutide [another GLP-1 agonist] in the past in latent autoimmune diabetes, "commented a member of the audience after the presentation.
"Substantial residual beta cell function can leverage GLP-1 at diagnosis, which gives us a new way to look at newly diagnosed type 1 diabetes."
"It would be good to sub-badyze patients according to the title of the antibody," he added.
Dejgaard said his group was planning to do such badyzes despite the small size of the study.
Gunasekaran pointed out: "In the end, I think the problem is that we have been doing it for years, but we are not going to the fundamental problem that everyone will end up on insulin. Whatever the case may be, does the use of a drug like liraglutide present any additional benefit? You can use it, but in the long run this might not be a workable solution. "
Dejgaard has declared to be a consultant for Novo Nordisk, AstraZeneca and Boehringer Ingelheim. He has received support from Novo Nordisk and AstraZeneca for research. Gunasekaran has not reported any relevant financial relationship.
ADA 2019 Scientific Sessions Presented on June 8, 2019. Summary 59-OR
For more information on diabetes and endocrinology, follow us on Twitter and on Facebook.
[ad_2]
Source link
