Issue 118 Item 11 New Drug Holds Promise As Once-Daily Diabetes Therapy

It caused an increase in insulin secretion rate, suppression of glucagon secretion and a delay in gastric emptying. NN2211, an investigational drug has a pharmacokinetic profile indicating it may offer another option for once-daily treatment of diabetes, especially type 2 diabetes, European investigators report in the August issue of Diabetes Care.

NN2211 is a long-acting glucagon-like peptide 1 derivative, lead investigator Dr. Bodil Elbr nd of Novo Nordisk, Bagsvaerd, Denmark, and colleagues report. The researchers enrolled 72 healthy adult male volunteers in a randomized, placebo-controlled dose-escalating study of NN2211.

Eight consecutive dose schedules, ranging from 1.25 to 20 g /kg, were analyzed. In each dose group, three of eight subjects underwent intravenous glucose tolerance testing 9 hours after drug administration. The drug was administered subcutaneously, and 24-hour glucose, insulin and glucagon profiles were assessed in the subjects.

Dr. Elbr nd group notes that the half-life of NN2211 was 11 to 15 hours. NN2211 showed "borderline-significant " lowering of glucose levels compared with placebo. In patients who underwent glucose tolerance testing, there was a statistically significant increase in insulin secretion but no significant effect on glucagon levels.

The investigators point out that "the observed stimulation of insulin secretion was clearly dose-related (in contrast to the glucose increase)." They also note that "NN2211 was found to reduce fasting and post-prandial glycemia."

"This effect was found to be mediated via an increase in insulin secretion rate, suppression of glucagon secretion and a delay in gastric emptying," Dr. Elbr nd’s team writes.

The primary adverse events reported by patients were headache, dizziness, nausea and vomiting. The researchers suggest that the latter two symptoms are likely related to the delayed gastric emptying induced by NN2211. Diabetes Care 2002;25:1398-1404.

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