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Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00608179
First Posted: February 6, 2008
Last Update Posted: December 11, 2014
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.
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University
  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 (Participant)
Official Title: Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

Resource links provided by NLM:


Further study details as provided by Steve Davis, Vanderbilt University:

Primary Outcome Measures:
  • catecholamines [ Time Frame: 1 day ]

Enrollment: 32
Study Start Date: August 2002
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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00608179


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

Responsible Party: Steve Davis, Department Chair, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00608179     History of Changes
Other Study ID Numbers: IRB #020690
First Submitted: January 25, 2008
First Posted: February 6, 2008
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Steve Davis, Vanderbilt University:
epinephrine
glucose clamp

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Glyburide
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors