Very Interesting Diabetes Article

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Found this in Medscape this AM.

Oral Insulin Effective in Type 2 Diabetes

Laurie Barclay, MD

Jan. 31, 2003 - A new oral insulin formulation was as effective in

controlling blood sugars as injectable regular insulin in a small group of

type 2 diabetics, according to the results of a randomized, single-blind

study reported in the February issue of Diabetes Care.

" There is strong evidence suggesting that an oral insulin product would

provide insulin in a more physiologic manner [than injectable insulin], with

a resultant decrease in peripheral insulin concentrations, and that it would

more adequately 'insulinize' the liver, " write Mark Kipnes, MD, from Diabetes

and Glandular Disease Research Associates in San , Texas, and

colleagues.

The investigators enrolled 18 patients with type 2 diabetes in this three-way

crossover, dose-escalation study. Each subject received a single dose of each

of the following study drugs on three separate days: oral hexyl-insulin

monoconjugate 2 (HIM2; 0.375, 0.5, or 1.0 mg/kg), subcutaneous regular

insulin (8 units Humulin R), and oral placebo. At 30 minutes after each dose,

subjects ingested 16 oz of Boost Plus containing 720 calories, and plasma

glucose and insulin concentrations were determined during the four-hour

postdose period.

The mean glucose area under the curve for 0 to 240 min (AUC[0-240]) values

were lower following administration of 0.5 and 1.0 mg/kg HIM2 vs. placebo

(1,097.1 vs. 1,196.9 and 801.1 vs. 992.1 mg/h/dL, respectively). The mean

glucose AUC(0-240) values were similar after administration of 0.5 and 1.0

mg/kg HIM2 vs. subcutaneous insulin (1,097.1 vs. 1,048.0 and 801.1 vs. 875.2

mg/h/dL).

Pooled data from the 0.5- and 1.0-mg/kg dose groups suggested that HIM2 and

subcutaneous insulin were equivalent in terms of effect on two-hour

postprandial glucose concentration, maximum postprandial glucose

concentration, and glucose AUC(0-240). However, peripheral insulin

concentrations were lower with HIM2 than with subcutaneous insulin (mean

insulin AUC(0-240) of 193.1 vs. 233.6 and 230.8 vs. 270.3 micro U/h/mL,

respectively).

Oral insulin was safe, well tolerated, more effective than placebo, and as

effective as subcutaneous regular insulin at controlling postprandial

glycemia, even though peripheral insulin concentrations were lower after the

administration of oral insulin compared with subcutaneous insulin.

" Thus, HIM2 therapy may control postprandial glycemia without causing

peripheral hyperinsulinemia in patients with type 2 diabetes, " the authors

write. " The results of this study suggest that oral HIM2 may be useful in

patients with type 2 diabetes who experience inadequate postprandial glycemic

control. "

Nobex Corporation supported this study.

Diabetes Care. 2003;26:421-426

Reviewed by D. Vogin, MD

Becki

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