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Potassium Channel Opener

Diazoxide for Type 2 Diabetes

Phase 2
Recruiting
Led By Meredith Hawkins, M.D., M.S.
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No family history of diabetes among first degree relatives (eg. mother, father)
Not suffering from a previously diagnosed proliferative retinopathy, significant diabetic renal disease or severe neuropathy (including cardiovascular and gastrointestinal autonomic dysfunction).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-7.5 hours
Awards & highlights

Study Summary

This trial looks at the effects of diazoxide on the brain and how it regulates glucose production by the liver in people with type 2 diabetes.

Who is the study for?
This trial is for adults aged 21-70 with type 2 diabetes, having an A1c level between 8.0-12.0%, and a BMI under 35 without severe diabetic complications or family history of diabetes. Healthy participants with no diabetes can also join if they meet the age, BMI, and blood sugar criteria.Check my eligibility
What is being tested?
The study tests how diazoxide affects liver glucose production in people with type 2 diabetes compared to a placebo and nicotinic acid. It aims to understand the brain's role in regulating blood sugar levels by potentially activating certain control centers.See study design
What are the potential side effects?
Possible side effects include low blood sugar (hypoglycemia), digestive issues, potential allergic reactions to medications used during the study, and changes in heart rate or blood pressure due to nicotinic acid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My immediate family does not have a history of diabetes.
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I do not have severe eye, kidney, or nerve problems related to diabetes.
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I am 21-70 years old, have a BMI under 35, no drug use, normal blood sugar levels, and no close family with diabetes.
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I am between 21 and 70 years old.
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If you have type 2 diabetes, you must be between 21 and 70 years old, have a body mass index under 35, and have a certain range of A1c levels. You should also not have certain eye, kidney, or nerve problems related to diabetes.
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I have passed a drug test recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-7.5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-7.5 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endogenous glucose production (EGP)

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: T2D (Nicotinic Acid + placebo for diazoxide)Experimental Treatment2 Interventions
Pancreatic clamp study will be done after lowering free fatty acids with a nicotinic acid (Niacin) infusion in type 2 diabetic participants, and after giving a taste-matched placebo for Diazoxide (Proglycem) to type 2 diabetic participants.
Group II: T2D (Diazoxide)Experimental Treatment1 Intervention
Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to type 2 diabetic participants.
Group III: T2D (Diazoxide + Nicotinic Acid)Experimental Treatment2 Interventions
Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to type 2 diabetic participants after lowering free fatty acids with a nicotinic acid (Niacin) infusion.
Group IV: Non-diabetic (Diazoxide)Experimental Treatment1 Intervention
Pancreatic clamp study will be done after giving Diazoxide (Proglycem) oral suspension to non-diabetic participants.
Group V: Non-diabetic (Placebo)Placebo Group1 Intervention
Pancreatic clamp study will be done after giving a taste-matched placebo for Diazoxide (Proglycem) to non-diabetic participants.
Group VI: T2D (Placebo)Placebo Group1 Intervention
Pancreatic clamp study will be done after giving a taste-matched placebo for Diazoxide (Proglycem) to type 2 diabetic participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Nicotinic acid
2018
Completed Phase 4
~720
Diazoxide
2006
Completed Phase 4
~80

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
285 Previous Clinical Trials
11,856,459 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,736 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,348 Previous Clinical Trials
4,314,672 Total Patients Enrolled

Media Library

Diazoxide (Potassium Channel Opener) Clinical Trial Eligibility Overview. Trial Name: NCT03540758 — Phase 2
Type 2 Diabetes Research Study Groups: T2D (Nicotinic Acid + placebo for diazoxide), Non-diabetic (Diazoxide), Non-diabetic (Placebo), T2D (Diazoxide + Nicotinic Acid), T2D (Placebo), T2D (Diazoxide)
Type 2 Diabetes Clinical Trial 2023: Diazoxide Highlights & Side Effects. Trial Name: NCT03540758 — Phase 2
Diazoxide (Potassium Channel Opener) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03540758 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become a participant in this research?

"Eligibility criteria for this trial include being between 21 and 70 years old as well as having hyperglycemia. Currently, the study is looking to recruit 30 more individuals."

Answered by AI

What medical conditions are typically treated with Diazoxide?

"Diazoxide is most often used to mitigate cardiovascular risks but can also be employed to lower the risk of pancreatitis and lipidemia or to treat dyslipidemias."

Answered by AI

Are new volunteers still being sought for this experiment?

"The clinical trial is currently ongoing, with the most recent update being on June 15th, 2022. The study was initially posted on August 1st, 2018."

Answered by AI

How many people are being signed up for this experiment?

"That is correct, the clinicaltrials.gov webpage for this research indicates that it is actively looking for patients. This study was originally posted on August 1st, 2018 and was last updated on June 15th, 2022. The ideal candidate pool consists of 30 individuals who are willing to travel to a single location."

Answered by AI

Does this research study have an age limit?

"The eligibility requirements for this clinical trial state that patients between the ages of 21 and 70 may apply. There are 86 other trials available for minors and 899 options for seniors."

Answered by AI

Has Diazoxide been federally authorized for medical use?

"While there is some evidence supporting Diazoxide's safety, it remains unproven whether or not the drug is actually effective. Therefore, it received a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Albert Einstein College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Albert Einstein College of Medicine: < 48 hours
~21 spots leftby Apr 2027