An investigational new agent, a highly selective dipeptidyl peptidase-IV (DPP-4) inhibitor, has shown good efficacy and safety in the treatment of type 2 diabetes mellitus, according to results of a phase 1 study.
Dr. Qais A. Mekki, of Takeda Global Research and Development, presented findings of a randomized study of the drug, Takeda’s alogliptin, in 36 healthy men. They were given 25, 50, 100, 200, 400, or 800 mg or placebo.
Alogliptin was absorbed within 1-2 hours with all doses, with nearly complete inhibition of DPP-4. Inhibition ranged from 74.3% to 97.0% at 24 hours and from 47.5% to 83.0% at 72 hours.
Mean area under the curve (AUC) increased with increasing doses. Half-life was 12.4-21 hours. All doses were well-tolerated.
"DPP-4 enables the body to provide the body with insulin on demand," Dr. Mekki told Reuters Health. He added that because the drug’s target is very specific, it "has no off-target effects."
"We can see efficacy even in this short time period," Dr. Mekki said of the two-week observational period. "We have seen no cases of toxicity…It will not cause hypoglycemia, because it acts on demand. It is not active in normoglycemia."
"We are currently in phase 3 studies and have had no concerns. We plan to file a NDA in mid-2008," he said.
Presented at the 67th Scientific Session of the American Diabetes Association in Chicago.