NCT00608179

Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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?

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Glimepiride	Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
DRUG	glyburide	Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
OTHER	glucose clamp	Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
OTHER	glucose clamp	hypoglycemic glucose clamp procedure -120 minutes

Timeline

• Start date: 2002-08-01
• Primary completion: 2004-09-01
• Completion: 2010-12-01
• First posted: 2008-02-06
• Last updated: 2014-12-11