Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00608179

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:	Randomized, Single Blind (Subject), Factorial Assignment
Official Title:	Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Glyburide Insulin Dextrose Glimepiride

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:	August 2009
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Glimepiride Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
2: Experimental	Drug: glyburide Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
3: Experimental control-euglycemia	Other: glucose clamp Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
4: Experimental 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:	Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	IRB #020690
Study First Received:	January 25, 2008
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00608179 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

epinephrine
glucose clamp

Additional relevant MeSH terms:

Glyburide
Hypocalcemia
Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Hypoglycemia
Immunosuppressive Agents

Pharmacologic Actions
Calcium Metabolism Disorders
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Water-Electrolyte Imbalance
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010