Octreotide for the Treatment of Sulfonylurea-Associated Hypoglycemia
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
Background:
Hypoglycemia is a common presentation to the Emergency Department. Management has
traditionally involved rapid administration of IV 50% dextrose and dextrose containing IV
fluids in addition to oral carbohydrates. Hypoglycemic patients taking only insulin can often
times be treated as outlined above and safely discharged to home after a period of short
observation in the Emergency Department. This procedure is also followed in the pre-hospital
care arena, where insulin-dependent hypoglycemic patients are often treated and released.
In addition to diet-control and insulin, patients with diabetes maintain outpatient
euglycemia with a class of drugs called sulfonylurea agents. This are believed to stimulate
insulin release from pancreatic beta cells via a complex mechanism culminating in calcium
influx and release of stored insulin from secretory granules within the pancreas. Whereas
insulin-dependent diabetic patients are usually discharged home after establishing normal
blood glucose levels, hospital admission is generally recommended in hypoglycemic patients
taking oral sulfonylureas due to the long duration of effect and delayed clearance of the
drugs and their metabolites and subsequent high likelihood of recurrent hypoglycemic
episodes.
Octreotide is a somatostatin analog that is known to suppress numerous hormones including
insulin. Dextrose itself induces insulin secretion thus theoretically contributing to rebound
hypoglycemia when used to treat hypoglycemia. Octreotide is thought to block the elevated
insulin levels that are a result of both the sulfonlyureas and dextrose. Recent case reports
and one prospective study in healthy volunteers have demonstrated the safety and efficacy of
octreotide administration for the treatment of sulfonylurea induced hypoglycemia. Based
largely on the results of these studies some experts in field of toxicology have argued that
administration of octreotide be standard therapy for all patients with recurrent hypoglycemic
episodes who are known to be taking sulfonylureas.
Purpose:
Measure the difference in serum glucose and the incidence of hypoglycemia between two groups
of sulfonylurea-dependent patients; a control group that receives standard therapy and an
experimental group that receives standard therapy plus octreotide.