2 Two trials were performed to investigate the influence of timing and mode of administration of tendamistate, relative to starch intake, on the pharmacodynamics of the drug.

(i) In the first trial 400 mg enteric coated capsules, 400 mg non-enteric coated capsules and placebo were compared in 12 volunteers.

Medication (400 mg tendamistate capsules or placebo) was administered after 10 h fasting, 15 min before a starch meal. Post-prandial plasma glucose concentration-time curves were plotted. No significant differences could be shown between tendamistate capsules and placebo in respect of areas under the curve (AUC), maximal concentration (C_max) and time to maximal concentration (t_max). No side effects were reported.

(ii) In a second trial tendamistate powder, mixed with a starch meal, was compared with placebo in eight volunteers. Blood specimens for measurement of glucose, insulin and C-peptide were taken up to 8 h after this starch meal. AUC as well as C_max in respect of glucose values were significantly lower after Hoe 467 plus starch than after placebo plus starch. Insulin and C-peptide values were closely correlated with glucose. Flatulence and diarrhoea were reported by two subjects.

3 It is concluded that the administration of tendamistate with, but not prior to, starch ingestion is effective in reducing post-prandial glucose levels.