Rectal Insulin: A Potent Hypoglycemic Preparation

Bakth, S; Nh, Ertel; Pb, May; Akgün, Suat

doi:10.1055/s-2007-996209

Cited by 6 publications

(1 citation statement)

References 2 publications

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“…Alternate routes of insulin delivery, including rectal (1)(2)(3), vaginal (4) and buccal (5) administration, have met with limited success but have not gained wide acceptance by patients. Coated insulin tablets that escape upper GI tract destruction have been evaluated, but significant variations in the onset of hypoglycemia have been reported in rats.…”

Section: Introductionmentioning

confidence: 99%

Toxicity of Insulin Administered Chronically to Human Eye In Vivo

Bartlett¹,

Slusser²,

Turner-Henson³

et al. 1994

Journal of Ocular Pharmacology and Therapeutics

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Insulin administered in eyedrop from with a surfactant agent has been shown to be clinically effective in treating diabetes in animal models. Concentrations of insulin as high as 100 U/ml in saline were shown to produce no detectable clinical toxicity to human eyes in single-dose administration. We sought to investigate the local toxicity of insulin in human eyes during longterm, multidose administration. A prospective, randomized, placebo controlled, double-masked study was conducted involving eight healthy volunteers. Subjects were given 50 pi sterile saline containing 100 U/ml crystalline porcine insulin randomized to one eye and 50 pi placebo (sterile saline) to the fellow eye administered twice daily for 8 weeks. Subjective ocular irritation and visual acuity and objective assessment of the eyelids, conjunctiva, comea, anterior chamber, crystalline lens, pupil size, and intraocular pressure were evaluated. Blood D-glucose levels were monitored to assess glycémie levels. There was no statistically significant difference (p>0.05) observed between insulin-treated and placebo-treated eyes. Eyedrops containing insulin were subjectively as comfortable and objectively as clinically innocuous as sterile saline alone. The results of this study demonstrate that insulin (100 U/ml) in saline is nontoxic to the human eye after long-term, multi-dose exposure. Topical administration of insulin combined with an absorption-promoting agent may be a practical and feasible alternative to multiple daily subcutaneous injections or implanted pump devices currently used in the long-term treatment of diabetes mellitus if a nonirritating absorption-promoting agent can be identified. Further studies are warranted to determine the toxicity and efficacy of these absorption-promoting agents in humans and to develop an eyedrop formulation that maximizes safety, efficacy and compliance in patients with diabetes mellitus.

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