A new basal insulin now in Phase III trials worldwide promises to offer a smoother action than NPH with a more predictable activity curve.
Insulin detemir, developed by Novo Nordisk, is an intermediate-acting basal insulin analog administered as a clear solution. Novo Nordisk spokeswoman Susan Jackson says, “Compared to NPH insulin, detemir is absorbed with less variability and provides a flatter action profile.”
In comparison trials that pitted detemir and NPH against each other, researchers found that absorption of NPH varied 20 to 30 percent on a daily basis. Also, because NPH is a suspension insulin, the concentration may change because of inadequate mixing. NPH in a vial must be rolled between the hands until the components are mixed. If NPH is used in a pen, the pen needs to be inverted at least 20 times to ensure an even distribution of the suspension.
Detemir, on the other hand, does not need to be mixed. In addition, it bonds to proteins at the injection site and in the bloodstream, which slows down the transportation of insulin to the tissues and across membranes, Jackson says.
When given overnight, there was a delayed onset of action for detemir compared to NPH, which resulted in fewer incidents of nighttime hypoglycemia. There also was less variability in fasting numbers when subjects in the study took detemir than when they took NPH.
While a report published in the February issue of Diabetes Care noted that subjects had to take 2.35 times the amount of detemir as NPH, Novo Nordisk’s head of investor relations, Peter Haahr, said recently that the formulation has been adjusted.
“When it gets to the market, it will be the same as NPH in terms of units,” Haahr said in a telephone interview from Denmark. “We now have a higher concentration of insulin in the detemir.”
Haahr said he could not state when Phase III trials, which began in February 1999, will be completed, nor could he say when Novo Nordisk will seek approval for detemir from the U.S. Food and Drug Administration.
“In Phase III, we need to do trials both on type 1 and type 2 [diabetes] and try different treatment regimens,” Haahr said. “We expect that a basal insulin will have a longer time in Phase III. We expect to go into next year. If it’s a significant compound, we will be getting approval.”