Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

Type 2 Diabetes Clinical Trial

Official title:

Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608179
• Other study ID #: IRB #020690
• Status: Completed
• Phase: N/A
• First received: January 25, 2008
• Last updated: December 10, 2014
• Start date: August 2002
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hypoglycemia
• Type 2 Diabetes

Intervention

Drug:
• Glimepiride
Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
• 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
• glucose clamp
hypoglycemic glucose clamp procedure -120 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catecholamines		1 day	No