The U.S. FDA has informed Novo Nordisk that a three-month extension period was required in order to complete its regulatory review of the new drug applications (NDA) for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart...
Category: Insulin
The U.S. Food and Drug Administration (FDA) has approved Levemir (insulin detemir [rDNA origin] injection) for use in children ages two to five years with type 1 diabetes, making it the first and only basal insulin analog for use in this young patient group. With the expansion of its pediatric indication...
Two new phase 3 studies published in The Lancet show that ultra long acting insulin, Degludec, an investigational compound from Novo Nordisk, significantly reduces the rates of nocturnal hypoglycemia by 25%, compared to insulin glargine.
The two studies included in total 1,635 participants and investigated insulin degludec compared to insulin...
Biodel Inc. announced positive top-line results from a Phase 1 clinical trial of its product candidates, BIOD-123 and BIOD-125 -- two proprietary ultra rapid acting formulations of recombinant human insulin (RHI). The objective of the trial was to identify...
Dr. Jovanovic even recommends using Levemir injections at night to women using insulin pumps, as she prefers the assurance of a basal shot...
The U.S. FDA has approved Novo Nordisk's Levemir insulin (insulin detemir [rDNA origin] injection) for use by pregnant women with diabetes, giving it a Category B classification, indicating that it does not increase the risk of harm to the unborn baby.
The label update makes Levemir the first and only basal insulin analog to have this classification...
Studies have shown that excess insulin circulating in the bloodstream is a major independent risk factor for cardiovascular disease. However, a new study from Joslin Diabetes Center finds that this condition, called hyperinsulinemia, itself does not cause hardening of the arteries, also known as atherosclerosis...
The creation of oral insulin has been no simple task. "People have been dreaming about oral insulin since 1922," Dr. Kidron said...
A study released by Novo Nordisk at the International Diabetes Federation (IDF) 21st World Diabetes Congress in Dubai has found that the combination insulin degludec/insulin aspart, currently being developed, significantly reduced hypoglycemia in type 1 diabetes and type 2 diabetes patients...
Data from the A1chieve® study, evaluating adverse events and effectiveness of Novo Nordisk insulins (NovoMix 30, Levemir and NovoRapid) in 66,726 people with type 2 diabetes, shows that type 2 diabetes patients can significantly improve their blood glucose control with a low occurrence of low blood sugar (hypoglycemia)...