|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00608179 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Drug: Glimepiride Drug: glyburide Other: glucose clamp |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (Subject) |
| Official Title: | Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Glimepiride
Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
Other Name: Amaryl
|
| Experimental: 2 |
Drug: glyburide
Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
Other Name: Dia-Beta
|
|
Experimental: 3
control-euglycemia
|
Other: glucose clamp
Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
|
|
Experimental: 4
control-hypoglycemia
|
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?
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Stephen N. Davis, MD, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00608179 History of Changes |
| Other Study ID Numbers: | IRB #020690 |
| Study First Received: | January 25, 2008 |
| Last Updated: | October 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
epinephrine glucose clamp |
|
Diabetes Mellitus, Type 2 Hypoglycemia Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Glyburide |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
