Octreotide for the Treatment of Sulfonylurea-Associated Hypoglycemia

NCT00804297 | Completed Phase 3

• 1 other identifier: (H)N-2877
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoglycemia; Diabetes Mellitus

Keywords

Hypoglycemia; Diabetes Mellitus; Octreotide

Outcome Measures

Primary Outcomes (1)

• mean glucose level for the non-octreotide group is higher than the octreotide group

Secondary Outcomes (1)

• number of hypoglicemic events

Interventions

Octreotide (drug) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypoglycemia (serum glucose \< 60mg/dl) and concurrent use of a sulfonylurea.

You may not qualify if:

• Age \<18. Pregnancy. Inability to provide informed consent.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus

Interventions

Octreotide; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Charles J Fasano, DO

  Albert Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: June 1, 2005
• Study Completion: January 1, 2007
• Last Updated: December 8, 2008

Record last verified: 2008-12

Locations

US (1)