PHARMACY

Insulin combination treats low blood sugar in diabetes patients, study finds

BY Alaric DeArment

DUBAI, United Arab Emirates — A combination of two insulins made by Novo Nordisk reduced abnormally low blood sugar in diabetes patients, according to study results presented at a medical conference.

Presenting at the International Diabetes Federation’s 21st World Diabetes Congress in Dubai, Novo Nordisk said the combination of insulin degludec and insulin aspart reduced the overall occurrence of low blood sugar, also known as hypoglycemia, during the day and at night for patients with Type 1 and Type 2 diabetes. The company markets insulin aspart under the NovoLog and NovoRapid brands, while insulin degludec is still in clinical development.

The combination also lowered the amount of sugar in patients’ blood plasma after a period of not eating, a measure known as fasting plasma glucose.

"The unique way in which insulin degludec/insulin aspart works, with the basal insulin providing an ultra-long and steady action profile, plus a bolus boost of insulin aspart, provides a simple way to introduce mealtime dosing at any meal," Novo Nordisk corporate VP and global chief medical officer Alan Moses said. "These benefits, along with the reduced risk of hypoglycemia and improved [fasting plasma glucose]  shown in these studies, are very promising for people living with diabetes."

A second study also showed rates of hypoglycemia that were 37% lower in Type 1 diabetes patients who took the combination and rapid-acting mealtime insulin doses compared with those who took the mealtime doses with insulin detemir, which the company sells under the Levemir brand.


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PHARMACY

FDA panel votes in favor of Pfizer kidney cancer drug

BY Alaric DeArment

NEW YORK — A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.

Pfizer announced that the FDA’s Oncologic Drugs Advisory Committee voted unanimously to state that axitinib’s benefits outweighed its risks in patients with advanced renal cell carcinoma for whom first-line treatments had failed.

"We are pleased with the panel’s recommendation in support of axitinib for the treatment of previously treated advanced RCC, as additional therapeutic options are still needed for this patient population," Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said. "We look forward to continued discussions with the FDA as we take the next steps in the regulatory process for axitinib."

The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but takes them into account and usually makes its decisions in accordance with them.


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Eli Lilly, Boehringer Ingelheim announce linagliptin trial results

BY Alaric DeArment

INDIANAPOLIS — A drug currently under clinical development for Type 2 diabetes produced "meaningful" reductions in blood sugar, according to results of a late-stage clinical study.

Eli Lilly & Co. and Boehringer Ingelheim announced results of a 24-week, open-label arm of a phase-3 study of the investigational drug linagliptin combined with the generic drug metformin, presenting results at the International Diabetes Federation World Diabetes Conference in Dubai.

After 24 weeks, the companies said, patients with poorly controlled blood sugar showed HbA1C reductions of 3.7%. Most patients tolerated the drug well, with 9% experiencing adverse side effects and 1.5% reporting abnormally low blood sugar, also known as hypoglycemia.

"Many patients with high HbA1C levels require more than metformin alone to reach their blood glucose targets," Boehringer Ingelheim corporate SVP medicine Klaus Dugi said. "Linagliptin can support patients with Type 2 diabetes to effectively manage their condition in order [to] reach their blood-glucose targets."

In another study, patients who could not take metformin were given linagliptin or the generic drug glimepiride in a 34-week extension phase of a one-year trial. HbA1C levels in linagliptin patients remained stable between week 18 and week 52. Glimepiride showed similar levels of efficacy, but linagliptin produced fewer adverse side effects, the companies said.

 


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