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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

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 15 minutes during the first and third 2-hour hypoglycemic episodes (on day 1 and day 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in peak epinephrine levels between first and third hypoglycemic episodes

Secondary study objectives

Endogenous glucose production (EGP)

Symptoms of low blood sugar (hypoglycemia)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Naloxone

2014

Completed Phase 3

~1290

Diazoxide

2006

Completed Phase 4

~80