Issue 145 Item 8 Oral Insulin Controls Postprandial Glucose in Type 2 Diabetics

Controls postprandial glucose without causing peripheral hyperinsulinemia. An experimental oral insulin product, hexyl-insulin monoconjugate 2 (HIM2; Nobex Corp, Research Triangle Park, NC), may control postprandial glucose without causing peripheral hyperinsulinemia, which is known to occur with parenteral insulin therapy.

That’s according to the results of a study in the February issue of Diabetes Care led by Dr. Mark Kipnes of the Diabetes and Glandular Disease Clinic in San Antonio, Texas.

In a randomized, placebo-controlled, three-way crossover study, 18 type 2 diabetics were given a single dose of each of the following drugs on three separate days: oral HIM2 (0.375, 0.5, or 1.0 mg/kg), subcutaneous regular insulin (8 units Humulin R), and oral placebo. Thirty minutes after dosing, patients consumed a standardized meal and serial blood samples were obtained during the 4-hour postdose period.

HIM2 was safe and well tolerated and there were no episodes of hyperglycemia or hypoglycemia, the team reports.

For postprandial glucose control, HIM2, at the 0.5 and 1.0 mg/kg dosages, was more effective than placebo and as effective as subcutaneous insulin with respect to 2-hour postprandial glucose concentration, maximum glucose concentration, and glucose AUC 0-240 min.

Of note, according to the team, oral HIM2 provided postprandial glucose control comparable to that of subcutaneous insulin at lower peripheral insulin concentrations.

HIM2 seems to have an advantage over subcutaneous insulin, other than ease of administration, in that it mimics normal physiology. Unlike subcutaneous insulin, oral HIM2 passes through the liver and this appears to decrease the peripheral insulin level, ad Dr. Kipnes explained.

"This particular finding has a lot of different implications, all of which are positive," Dr. Kipnes went on to say. "Hyperinsulinemia seems to be associated with syndrome X, dyslipidemia, and heart disease. Also, if you give insulin to the liver first you might have less hypoglycemia and there might not be as narrow of a therapeutic window." Diabetes Care 2003;26:421-426.