Conference Coverage

Liraglutide tested as add-on therapy for type 1 diabetes

View on the News

Results show potential for GLP-1 agonists

The drug works. It makes sense. This study proves it. I think there’s a lot of potential for use of GLP-1 [glucagonlike peptide–1] agonists as additional therapy to insulin in type 1 diabetes given their unique mode of action, and especially since today many patients are overweight. About 35% of type 1 diabetes patients, and maybe even more, are beginning to show insulin resistance because they’re overweight. Getting a drug on board that promotes weight loss as well as helps control blood sugar is very valuable.

The drug is already being prescribed to some extent on an off-label basis, but insurance companies don’t approve or reimburse for its use in type 1 diabetes.

Paul Jellinger, M.D., is professor of clinical medicine at the University of Miami and an endocrinologist in Hollywood, Fla. He is on the speakers bureaus for Novo Nordisk, Boehringer Ingelheim, Janssen, Bristol-Myers Squibb, and Amarin. He was not involved in the study.


 

AT AACE 2014

References

LAS VEGAS – In patients with type 1 diabetes, adding a 1.8-mg daily dose of liraglutide to insulin significantly reduced hemoglobin A1c, mean blood glucose, body weight, carbohydrate intake, and C-reactive protein, in a randomized study.

The 72-patient study also showed that adding liraglutide (Victoza) significantly improved quality of life and reduced systolic blood pressure in the groups that were receiving higher doses of the medicine.

Naseem Miller/Frontline Medical News

Dr. Nitesh Kuhadiya

"Our findings have significant implications for the future treatment of type 1 diabetes," said Dr. Nitesh Kuhadiya of the State University of New York at Buffalo, who presented the findings at the annual meeting of the American Association of Clinical Endocrinologists. "Long term studies are needed to establish the durability of the effects."

In previous small, nonrandomized studies of patients with type 1 diabetes, liraglutide improved glycemic control and led to weight loss (Eur. J. Endocrinol. 2011;165:77-84; Endocr. Pract. 2013;19:963-7). They then decided to conduct a randomized controlled trial, which is the first of its kind, said Dr. Kuhadiya, who compared type 1 diabetes to a "wild horse that’s extremely difficult to tame and kicks you 10 times a day."

For the study, researchers randomized 72 patients to four groups to receive 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks. One patient dropped out of placebo group, as well as five from the 1.2-mg and three from the 1.8-mg group.

The groups’ baseline characteristics were similar. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, and had no detectable C-peptide in plasma. The mean age was 44 years, mean body weight was 83 kg, mean body mass index was 29 kg/m2, mean HbA1c was 7.5, and mean interval since diabetes diagnosis was 20 years. Nearly all (96%) patients were white and 56% were women.

There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2- and 1.8-mg groups. The HbA1c, also dropped in those two groups, although it was significant in only the 1.2-mg group, by about 0.8%. The drop was 0.4% in 1.8-mg group, 0.2% in the 0.6-mg group, and 0.3% in the placebo subjects.

There were also significant changes in the percent time spent in different glycemic thresholds for the 1.8-mg group.

Patients on 1.2 mg and 1.8 mg of liraglutide spent about 3%-5% more time in the 70- to 160-mg/dL zone, respectively, although only those on 1.8 mg reached statistical significance.

Again, the 1.2- and 1.8-mg groups spent less time in hyperglycemia, defined as 160-240 mg/dL, Dr. Kuhadiya said. No significant changes were observed in the other two groups.

A similar trend was seen for severe hyperglycemia (250 mg/dL).

There was, however, some additional hypoglycemia in the study in the range of 55 to 70 mg/dL, Dr. Kuhadiya reported. The 1.2- and 1.8-mg groups spent significantly more time (nearly 1%) in that range, but there was no incidence of hypoglycemia in the placebo and 0.6-mg groups. The results were similar for the less than 50 mg/dL range. However, there was no incidence of hypoglycemia requiring hospitalization or medical attention, Dr. Kuhadiya said.

All three groups receiving liraglutide showed significant weight loss: nearly 5 kg in the 1.2- and 1.8-mg groups, and 3 kg in the 0.6-mg group, over a period of 12 weeks.

The carbohydrate intake for the 1.2- and 1.8-mg groups also dropped significantly.

Dr. Kuhadiya said that the findings also show that all changes are independent of each other.

All groups showed a fall in C-reactive protein, which is a marker for cardiovascular risk, although only the 1.8-mg groups showed a statistical significance. "And this is important because most patients with type 1 diabetes have metabolic syndrome, and to be able to demonstrate all these changes and an additional fall in CRP means further protection from cardiovascular risk," Dr. Kuhadiya said.

The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

Recommended Reading

Diabetes, hypertension drive higher CVD risk in blacks and women
MDedge Endocrinology
Sodium controversy: More fuel for the fire
MDedge Endocrinology
New protocol improves diabetic acidosis management in ED
MDedge Endocrinology
Predischarge preparation for diabetes management lowers recidivism
MDedge Endocrinology
Lilly’s insulin glargine tentatively approved, pending patent litigation
MDedge Endocrinology
Type 1 diabetes test gets FDA go-ahead
MDedge Endocrinology
Gestational diabetes and the Barker Hypothesis
MDedge Endocrinology
USPSTF: Offer behavioral counseling to prevent cardiovascular disease
MDedge Endocrinology
DPPOS: Metformin showed no effect on cognition
MDedge Endocrinology
Islet transplants aided type 1 diabetes patients
MDedge Endocrinology