Type 2 DiabetesPhase 4NCT01028846
Central Mechanisms That Regulate Glucose Metabolism in Humans
A Phase 4 study testing Diazoxide in people with Type 2 Diabetes and Glucose Metabolism Disorders, run by Meredith Hawkins at 1 site in United States.
Trial summary
Type 2 diabetes is a chronic condition that affects the ability of the body to regulate glucose (sugar). When glucose levels are low, the liver can make glucose to increase levels in the body. This important process is called endogenous glucose production (EGP). Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Glucose Metabolism Disorders, Glucose, High Blood
- What is being tested?
- Diazoxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2006to 5 Dec 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Be no more than 140% of body weight
- No concurrent illnesses
Who cannot join
- No clinical history or laboratory evidence of hyperlipidemia (LDL cholesterol < 160 mg/dL)
- Clinical history of Hypertension
- Clinical history of Heart disease
- Clinical history of Cerebrovascular disease
- Clinical history of Seizures
- Clinical history of Bleeding disorders
Show all 15Show fewer
- Clinical history of Muscle disease
- Smokers
- Mentally disabled persons
- Prisoners
- Pregnancy
- Clinical history of ethanol or drug or toxin exposure which could be associated with neuropathy
- Subjects incapable of giving voluntary informed consent
- History of bleeding disorder
- Clinical history of prolonged Prothrombin Time (PT) or Partial Thromboplastin Time
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Type 2 diabetes is a chronic condition that affects the ability of the body to regulate glucose (sugar). When glucose levels are low, the liver can make glucose to increase levels in the body. This important process is called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to coordinate this process by communicating with the liver through potassium channels. Control of EGP can be impaired in people with type 2 diabetes, which may contribute to the high levels of glucose seen in these individuals.
The purpose of this study is to understand how activating these potassium channels in the control centers of the brain with a medication called diazoxide might inhibit the amount of glucose made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn causes hyperglycemia (high levels of sugar in the blood) that leads to diabetes complications.
Read the detailed description
In this study, the investigators will study healthy participants through a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (the production of sugar by the liver) will be measured in patients given diazoxide (a medication that activates potassium channels in the brain that may affect glucose production in the liver through brain-liver signaling), compared with when a placebo is given.
All experiments will consist of 240 min insulin/somatostatin (250 μg/hr) infusions with replacement of glucoregulatory hormones (glucagon 1 ng/kg·min; growth hormone 3 ng/kg·min). Throughout the study, the plasma glucose concentration will be maintained at basal levels ( ~90 mg/dl). This will be attained by infusion of insulin at adequate rates to maintain normoglycemia without requiring glucose infusion. Primed continuous infusions of High-performance liquid chromatography-purified [3-3H]-glucose will be initiated at t=0 (21.6 μCi bolus, then 0.15 μCi/min), to measure glucose fluxes. All infusions will be stopped at t=240 min. From t=0 to t=240 min, blood samples will be obtained for determinations of plasma glucose, insulin, glucagon, C-peptide, cortisol, growth hormone, free fatty acids (FFA), glycerol, and lactate, and for 3-3H-glucose determinations.
This registration is exclusive to Aim 1 of the study protocol, which determined the effect of diazoxide on hepatic glucose production in nondiabetic, healthy, young individuals under fixed hormonal conditions. Euglycemic (90 mg/dl x 4 hours) pancreatic clamp studies (n= 10), with either saline or diazoxide infusion.
- Being tested
- Diazoxide, Placebo
- Keywords
- Type 2 Diabetes, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazoxideDrug
Also called Proglycem
4 mg/kg body weight total dosage administered orally
PlaceboDrug
Oral saline
| Study group | Role | What they receive |
|---|---|---|
| Diazoxide | Active comparator | 4 mg/kg body weight total dosage administered orally during pancreatic clamp study Receives: Drug: Diazoxide |
| Placebo | Placebo comparator | Saline administered orally during pancreatic clamp study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Endogenous Glucose Production (EGP)
Rate of EGP (a measure of the body's production of sugar) was measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., diazoxide or placebo) by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Rates were summarized by treatment (Diazoxide or Placebo) in mg/kg/min sing basic descriptive statistics.
Measured: Final 60 minutes (t=180-240 minutes) of the pancreatic clamp, 6-7 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study start2 Nov 2006
- Primary completion5 Dec 2007
- Study completion5 Dec 2007
Why it stopped: IRB approval expired 6/13/2023. Primary Completion Date and Study Completion Date updated after definitions were explained to PI/study team. Study never reached intended enrollment and will be categorized as terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants received placebo or diazoxide in a randomized, double-blinded fashion.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meredith Hawkins
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association
- Responsible party
- Sponsor-investigator, Meredith Hawkins, Albert Einstein College of Medicine
- Investigators
- Meredith Hawkins, M.D., M.S., Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028846
- Sponsor's protocol ID
- 2006-414
- Other IDs
- R01DK069861
- Status last verified
- May 2025
- First submitted
- 7 Dec 2009
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kishore P, Boucai L, Zhang K, Li W, Koppaka S, Kehlenbrink S, Schiwek A, Esterson YB, Mehta D, Bursheh S, Su Y, Gutierrez-Juarez R, Muzumdar R, Schwartz GJ, Hawkins M. Activation of K(ATP) channels suppresses glucose production in humans. J Clin Invest. 2011 Dec;121(12):4916-20. doi: 10.1172/JCI58035. Epub 2011 Nov 7.
PubMed 22056385
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Mechanisms That Regulate Glucose Metabolism in Humans
- ClinicalTrials.gov ID
- NCT01028846
- Acronym / sponsor ID
- 2006-414
- Keywords
- Type 2 Diabetes, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB approval expired 6/13/2023. Primary Completion Date and Study Completion Date updated after definitions were explained to PI/study team. Study never reached intended enrollment and will be categorized as terminated.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Meredith HawkinsUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association
- Study start
- 2 Nov 2006 (actual)
- Primary completion
- 5 Dec 2007 (actual)
- Study completion
- 5 Dec 2007 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes is a chronic condition that affects the ability of the body to regulate glucose (sugar). When glucose levels are low, the liver can make glucose to increase levels in the body. This important process is called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to coordinate this process by communicating with the liver through potassium channels. Control of EGP can be impaired in people with type 2 diabetes, which may contribute to the high levels of glucose seen in these individuals.
The purpose of this study is to understand how activating these potassium channels in the control centers of the brain with a medication called diazoxide might inhibit the amount of glucose made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn causes hyperglycemia (high levels of sugar in the blood) that leads to diabetes complications.
Detailed description
In this study, the investigators will study healthy participants through a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (the production of sugar by the liver) will be measured in patients given diazoxide (a medication that activates potassium channels in the brain that may affect glucose production in the liver through brain-liver signaling), compared with when a placebo is given.
All experiments will consist of 240 min insulin/somatostatin (250 μg/hr) infusions with replacement of glucoregulatory hormones (glucagon 1 ng/kg·min; growth hormone 3 ng/kg·min). Throughout the study, the plasma glucose concentration will be maintained at basal levels ( ~90 mg/dl). This will be attained by infusion of insulin at adequate rates to maintain normoglycemia without requiring glucose infusion. Primed continuous infusions of High-performance liquid chromatography-purified [3-3H]-glucose will be initiated at t=0 (21.6 μCi bolus, then 0.15 μCi/min), to measure glucose fluxes. All infusions will be stopped at t=240 min. From t=0 to t=240 min, blood samples will be obtained for determinations of plasma glucose, insulin, glucagon, C-peptide, cortisol, growth hormone, free fatty acids (FFA), glycerol, and lactate, and for 3-3H-glucose determinations.
This registration is exclusive to Aim 1 of the study protocol, which determined the effect of diazoxide on hepatic glucose production in nondiabetic, healthy, young individuals under fixed hormonal conditions. Euglycemic (90 mg/dl x 4 hours) pancreatic clamp studies (n= 10), with either saline or diazoxide infusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All participants received placebo or diazoxide in a randomized, double-blinded fashion.
| Arm | Type | Receives |
|---|---|---|
| Diazoxide | Active comparator | Drug: Diazoxide4 mg/kg body weight total dosage administered orally during pancreatic clamp study |
| Placebo | Placebo comparator | Drug: PlaceboSaline administered orally during pancreatic clamp study |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Be no more than 140% of body weight
- No concurrent illnesses
Key exclusion criteria (15 listed)
- No clinical history or laboratory evidence of hyperlipidemia (LDL cholesterol < 160 mg/dL)
- Clinical history of Hypertension
- Clinical history of Heart disease
- Clinical history of Cerebrovascular disease
- Clinical history of Seizures
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 |
|---|---|---|
| DiazoxideAlso: Proglycem4 mg/kg body weight total dosage administered orally | Drug | Diazoxide |
| PlaceboOral saline | Drug | Placebo |
Primary outcome
Rate of Endogenous Glucose Production (EGP)
Time frame: Final 60 minutes (t=180-240 minutes) of the pancreatic clamp, 6-7 hours after dosing
Rate of EGP (a measure of the body's production of sugar) was measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., diazoxide or placebo) by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Rates were summarized by treatment (Diazoxide or Placebo) in mg/kg/min sing basic descriptive statistics.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22056385Kishore P, Boucai L, Zhang K, Li W, Koppaka S, Kehlenbrink S, Schiwek A, Esterson YB, Mehta D, Bursheh S, Su Y, Gutierrez-Juarez R, Muzumdar R, Schwartz GJ, Hawkins M. Activation of K(ATP) channels suppresses glucose production in humans. J Clin Invest. 2011 Dec;121(12):4916-20. doi: 10.1172/JCI58035. Epub 2011 Nov 7.
- Individual participant dataSharing planned: No
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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.
Meredith Hawkins, M.D., M.S. principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diazoxide in people with Type 2 Diabetes and Glucose Metabolism Disorders, run by Meredith Hawkins at 1 site in United States.
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 3 inclusion and 15 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: stopped early, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Endogenous Glucose Production (EGP) (time frame: Final 60 minutes (t=180-240 minutes) of the pancreatic clamp, 6-7 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028846, which also lists 1 linked publication.
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 16 May 2025.