Octreotide for the Treatment of Sulfonylurea-Associated Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804297
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : December 8, 2008
Information provided by:
Albert Einstein Healthcare Network

Brief Summary:


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.


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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Diabetes Mellitus Drug: Octreotide (drug) Phase 3

Detailed Description:


All adult (>18 years old) non-pregnant patients presenting to the Emergency Department with hypoglycemia (serum glucose < 60 mg/dl) will be identified and screened for inclusion by the ED physicians and research staff. Hypoglycemic patients whose glucose-control medications involve only insulin will be excluded. All patients whose medications involve oral sulfonlyureas or a combination of insulin and sulfonylureas will be asked to participate in this study. Patients will be required to read and sign an informed consent outlining the objectives and risks/ benefits of the proposed protocol. In addition to reading the consent, details of the study will be explained verbally by a trained emergency medicine research assistant and patients will be given the opportunity to have all their questions answered.

Study patients will be randomized to one of two treatment arms.

  1. Standard treatment and placebo One ampule (50 mL) of IV 50% dextrose, oral carbohydrates and placebo (1cc of 0.9 % Normal Saline subcutaneuously) or
  2. Standard treatment plus 75 micrograms octreotide subcutaneously.

Enrolled patients will not receive additional maintenance IV glucose fluids unless they become hypoglycemic (serum glucose < 60 mg/dL), in which case they will receive bolus doses of IV 50% dextrose and re-evaluated. All enrolled patients will be admitted to the hospital and monitored for recurrent hypoglycemic episodes. Bedside glucose determinations will be collected hourly for 4 hours followed by repeated calculations every 2 hours. Data points to be collected will include the mean serum glucose, number of hypoglycemic episodes (<60mg/dl) and total quantity of dextrose required to maintain euglycemia.

In the likely event that the hypoglycemia was diagnosed in the pre-hospital setting and the patient received IV 50% dextrose prior to arrival to the Emergency Department, a rapid bedside glucose determination will be obtained and if <60 mg/dl a second bolus of IV 50% dextrose given and the patient screened and approached about participation. If the emergency department serum glucose is >60mg/dl the patient will be screened and approached about participation without a second bolus of IV 50% dextrose.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Octreotide and Standard Therapy vs. Standard Therapy Alone for the Treatment of Hypoglycemia in Patients Taking Sulfonylureas or a Combination of Insulin and Sulfonylureas Presenting to the Emergency Department
Study Start Date : June 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Primary Outcome Measures :
  1. mean glucose level for the non-octreotide group is higher than the octreotide group

Secondary Outcome Measures :
  1. number of hypoglicemic events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00804297

United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Principal Investigator: Charles J Fasano, DO Albert Einstein Medical Center Identifier: NCT00804297     History of Changes
Other Study ID Numbers: (H)N-2877
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: December 2008

Keywords provided by Albert Einstein Healthcare Network:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents