Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: glucose clamp; Drug: Glimepiride; Drug: glyburide

• Registration Number: NCT00608179
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

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?

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-09
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-06
• Study Completion: 2010-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
3	glucose clamp	control-euglycemia
1	Glimepiride	-
2	glyburide	-
4	glucose clamp	control-hypoglycemia

Primary Outcome Measures

Name	Time	Method
catecholamines	1 day