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Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00608179
First received: January 25, 2008
Last updated: October 12, 2010
Last verified: October 2010
History of Changes
  Purpose

This study will look at two FDA approved medications that improve how the pancreas works in patients with Type 2 Diabetes. In order to understand how these medications work in patients with diabetes we must first measure the normal response in healthy volunteers without diabetes. We will be looking at the body's normal physiological response to low blood sugar and whether this will be modified by these medicationsThe hypothesis would be that glimepiride induced insulin secretion will be inhibited by hypoglycemia.


Condition Intervention
Type 2 Diabetes
 Drug: Glimepiride
Drug: glyburide
Other: glucose clamp

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • catecholamines [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2002
Estimated Study Completion Date: December 2010
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Glimepiride
Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
Other Name: Amaryl
Experimental: 2 Drug: glyburide
Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
Other Name: Dia-Beta
Experimental: 3
control-euglycemia
 Other: glucose clamp
Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
Experimental: 4
control-hypoglycemia
 Other: glucose clamp
hypoglycemic glucose clamp procedure -120 minutes

Detailed Description:

In patients with type 2 diabetes, sulfonylurea drugs are a mainstay for effective glucose control. These agents produce their hypoglycemic effects via stimulation of endogenous insulin secretion. Oversecretion of insulin, per se, or a continued relative increase of the hormone even when plasma glucose is normal will result in hypoglycemia. This latter situation commonly occurs if a patient decides to omit, delay, or reduce the size of a meal. An important defense against hypoglycemia in the above situations is glucose dependent regulation of insulin secretion. In other words, a low ambient glucose concentration could regulate the magnitude of the amount of insulin released in response to a sulfonylurea. Thus during hypoglycemic conditions, the sulfonylurea would result in little or no insulin secretion, whereas its effects during hyperglycemia would be amplified. Glimepiride and glyburide are both second-generation sulfonlyurea drugs used commonly for treatment of type 2 diabetes. This study will compare the two and ask the following question:

Is Glimepiride insulin secretion dependent upon glucose concentration in-vivo?

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects aged 30-60
  • Body Mass Index 21-30 kg/m2
  • All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities
  • EKG treadmill stress test for volunteers over 40 years of age.
  • Female volunteers of childbearing potential will undergo HCG pregnancy test.

Exclusion Criteria:

  • Prior or current history of poor health
  • Abnormal results following screening tests
  • Pregnancy
  • History of allergy to sulfonylurea or related drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608179

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Stephen N. Davis, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00608179     History of Changes
Other Study ID Numbers: IRB #020690
Study First Received: January 25, 2008
Last Updated: October 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
epinephrine
glucose clamp

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glyburide
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013