Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
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|ClinicalTrials.gov Identifier: NCT00608179|
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Glimepiride Drug: glyburide Other: glucose clamp||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||September 2004|
|Actual Study Completion Date :||December 2010|
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
- catecholamines [ Time Frame: 1 day ]
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
|Principal Investigator:||Stephen N. Davis, MD||Vanderbilt University|