Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
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.
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
|Official Title:||Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia|
- catecholamines [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||August 2002|
|Study Completion Date:||December 2010|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
Other Name: Amaryl
Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
Other Name: Dia-Beta
Other: glucose clamp
Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
Other: glucose clamp
hypoglycemic glucose clamp procedure -120 minutes
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?
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608179
|Principal Investigator:||Stephen N. Davis, MD||Vanderbilt University|