Type 2 DiabetesNCT00608179
Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
A study testing Glimepiride, glyburide and glucose clamp in people with Type 2 Diabetes, run by Vanderbilt University.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Glimepiride, glyburide and glucose clamp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Prior or current history of poor health
- Abnormal results following screening tests
- Pregnancy
- History of allergy to sulfonylurea or related drugs
About this study
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.
Read the detailed 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?
- Conditions
- Type 2 Diabetes
- Being tested
- Glimepiride, glyburide, glucose clamp
- Keywords
- epinephrine, glucose clamp
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlimepirideDrug
Also called Amaryl
Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
glyburideDrug
Also called Dia-Beta
Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
glucose clampOther
Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
glucose clampOther
hypoglycemic glucose clamp procedure -120 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Glimepiride |
| 2 | Experimental | Not described Receives: Drug: glyburide |
| 3 | Experimental | control-euglycemia Receives: Other: glucose clamp |
| 4 | Experimental | control-hypoglycemia Receives: Other: glucose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
catecholamines
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startAug 2002
- Primary completionSep 2004
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Davis, Vanderbilt University
- Investigators
- Stephen N. Davis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608179
- Sponsor's protocol ID
- IRB #020690
- Status last verified
- Dec 2014
- First submitted
- 25 Jan 2008
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
- ClinicalTrials.gov ID
- NCT00608179
- Acronym / sponsor ID
- IRB #020690
- Conditions
- Type 2 Diabetes
- Keywords
- epinephrine, glucose clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Sep 2004 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Glimepiride |
| 2 | Experimental | Drug: glyburide |
| 3 | Experimental | Other: glucose clampcontrol-euglycemia |
| 4 | Experimental | Other: glucose clampcontrol-hypoglycemia |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Prior or current history of poor health
- Abnormal results following screening tests
- Pregnancy
- History of allergy to sulfonylurea or related drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlimepirideAlso: AmarylGlimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol. | Drug | 1 |
| glyburideAlso: Dia-BetaGlyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol. | Drug | 2 |
| glucose clampHyperinsulinemic euglycemic glucose clamp procedure-120 minutes | Other | 3 |
| glucose clamphypoglycemic glucose clamp procedure -120 minutes | Other | 4 |
Primary outcome
catecholamines
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen N. Davis, MD principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing Glimepiride, glyburide and glucose clamp in people with Type 2 Diabetes, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catecholamines (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.