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Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

NCT ID: NCT00608179

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Type 2 Diabetes

Keywords

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epinephrine glucose clamp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Glimepiride

Intervention Type DRUG

Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.

2

Group Type EXPERIMENTAL

glyburide

Intervention Type DRUG

Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.

3

control-euglycemia

Group Type EXPERIMENTAL

glucose clamp

Intervention Type OTHER

Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes

4

control-hypoglycemia

Group Type EXPERIMENTAL

glucose clamp

Intervention Type OTHER

hypoglycemic glucose clamp procedure -120 minutes

Interventions

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Glimepiride

Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.

Intervention Type DRUG

glyburide

Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.

Intervention Type DRUG

glucose clamp

Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes

Intervention Type OTHER

glucose clamp

hypoglycemic glucose clamp procedure -120 minutes

Intervention Type OTHER

Other Intervention Names

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Amaryl Dia-Beta

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Steve Davis

Department Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen N. Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Other Identifiers

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IRB #020690

Identifier Type: -

Identifier Source: org_study_id