NCT00608179

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

January 25, 2008

Last Update Submit

December 10, 2014

Conditions

Type 2 Diabetes

Keywords

epinephrineglucose clamp

Outcome Measures

Primary Outcomes (1)

  • catecholamines

    1 day

Study Arms (4)

1

EXPERIMENTAL
Drug: Glimepiride

2

EXPERIMENTAL
Drug: glyburide

3

EXPERIMENTAL

control-euglycemia

Other: glucose clamp

4

EXPERIMENTAL

control-hypoglycemia

Other: glucose clamp

Interventions

GlimepirideDRUG

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

Also known as: Amaryl
1
glyburideDRUG

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

Also known as: Dia-Beta
2
glucose clampOTHER

Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes

3

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior or current history of poor health
  • Abnormal results following screening tests
  • Pregnancy
  • History of allergy to sulfonylurea or related drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepirideGlyburideGlucose Clamp Technique

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur CompoundsBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Stephen N. Davis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Chair

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 6, 2008

Study Start

August 1, 2002

Primary Completion

September 1, 2004

Study Completion

December 1, 2010

Last Updated

December 11, 2014

Record last verified: 2014-12