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Potassium Channel Activator
Diazoxide + Naloxone for Low Blood Sugar Prevention
Phase 4
Waitlist Available
Led By Meredith Hawkins, MD, MS
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 15 minutes during the first and third 2-hour hypoglycemic episodes (on day 1 and day 2)
Awards & highlights
Study Summary
This trial is testing whether two drug treatments can prevent unawareness of hypoglycemia in diabetics and improve the body's response to low blood sugar. Only healthy non-diabetics are being studied.
Who is the study for?
This trial is for healthy, non-diabetic individuals aged 21-55 who don't smoke heavily, have no major organ dysfunction or chronic diseases, aren't heavy drinkers, and have no family history of diabetes or premature cardiac death. Participants should not be on certain medications or enrolled in other medication trials recently.Check my eligibility
What is being tested?
The study tests if naloxone nasal spray and diazoxide can prevent Hypoglycemia Associated Autonomic Failure (HAAF) in people at risk. It has three phases: identifying at-risk individuals; testing naloxone vs placebo; and combining naloxone with diazoxide versus placebos.See study design
What are the potential side effects?
Potential side effects from the interventions may include mild to moderate reactions such as nausea, headache, dizziness, or local irritation from the nasal spray. Diazoxide could cause fluid retention or changes in blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 15 minutes during the first and third 2-hour hypoglycemic episodes (on day 1 and day 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 15 minutes during the first and third 2-hour hypoglycemic episodes (on day 1 and day 2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in peak epinephrine levels between first and third hypoglycemic episodes
Secondary outcome measures
Endogenous glucose production (EGP)
Symptoms of low blood sugar (hypoglycemia)
Trial Design
7Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Naloxone + diazoxideExperimental Treatment2 Interventions
Naloxone/Diazoxide evaluation: Up to 7 mg/kg oral diazoxide 3 hours before the first hypoglycemic episode. Intranasal naloxone (4 mg NARCAN Nasal Spray) via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Intranasal naloxone (4 mg NARCAN Nasal Spray) will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
Group II: NaloxoneExperimental Treatment1 Intervention
Naloxone evaluation: Intranasal naloxone (4 mg NARCAN Nasal Spray) via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Intranasal naloxone (4 mg NARCAN Nasal Spray) will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
Group III: No intervention (Susceptibility to HAAF evaluation)Active Control1 Intervention
Susceptibility to HAAF evaluation: No intervention medication will be given during episodes of hypoglycemia.
Group IV: Diazoxide + placebo (for naloxone)Active Control2 Interventions
Naloxone/Diazoxide evaluation: Up to 7 mg/kg oral diazoxide 3 hours before the first hypoglycemic episode. Placebo (for naloxone) nasal spray via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Placebo (for naloxone) nasal spray will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
Group V: Naloxone + placebo (for diazoxide)Active Control2 Interventions
Naloxone/Diazoxide evaluation: Oral placebo (for diazoxide) 3 hours before the first hypoglycemic episode. Intranasal naloxone (4 mg NARCAN Nasal Spray) via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Intranasal naloxone (4 mg NARCAN Nasal Spray) will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
Group VI: Placebo (for Naloxone)Placebo Group1 Intervention
Naloxone evaluation: Placebo (for naloxone) nasal spray via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Placebo (for naloxone) nasal spray will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
Group VII: Placebo (for naloxone) + placebo (for diazoxide)Placebo Group2 Interventions
Naloxone/Diazoxide evaluation: Oral placebo (for diazoxide) 3 hours before the first hypoglycemic episode. Placebo (for naloxone) nasal spray via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Placebo (for naloxone) nasal spray will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diazoxide
2006
Completed Phase 4
~80
Naloxone
2014
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,210 Total Patients Enrolled
1 Trials studying Hypoglycemia Unawareness
11 Patients Enrolled for Hypoglycemia Unawareness
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,376 Previous Clinical Trials
4,315,750 Total Patients Enrolled
5 Trials studying Hypoglycemia Unawareness
123 Patients Enrolled for Hypoglycemia Unawareness
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,191 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are between 21 and 55 years old and do not have diabetes.You have significant problems with your body's salt and mineral levels.You have a serious liver problem.You smoke more than 10 cigarettes per day.You have a serious problem with your kidneys.You drink a lot of alcohol.You have ongoing health issues like liver disease, heart problems, bleeding disorders, cancer, HIV/AIDS, seizures, or rheumatologic conditions.You have mental health conditions that are not being managed well.You have a significant issue with your platelet levels.You have a significant level of anemia that could affect your health.You have a body mass index (BMI) higher than 35, which means you are significantly overweight.Your close family members have had diabetes or died from heart problems at a young age.Your urine test shows important problems.You have tested positive for certain drugs like amphetamines, cocaine, or opioids.You have had surgery on your hormone-producing glands.You have a significant increase or decrease in your white blood cell count that is causing health problems.You are currently taking beta-blockers or medications that affect how your body responds to low blood sugar.Your blood pressure is consistently very high (over 150/90) or very low (under 90/60) on multiple occasions.Your triglycerides are higher than 400 mg/dL or your total cholesterol is higher than 300 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo (for Naloxone)
- Group 2: Placebo (for naloxone) + placebo (for diazoxide)
- Group 3: Naloxone + diazoxide
- Group 4: No intervention (Susceptibility to HAAF evaluation)
- Group 5: Naloxone
- Group 6: Diazoxide + placebo (for naloxone)
- Group 7: Naloxone + placebo (for diazoxide)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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