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Opioid Antagonist

1 for Type 1 Diabetes

Phase 2
Waitlist Available
Led By Elizabeth Seaquist, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 1 diabetes diagnosed on clinical grounds (history of DKA, use of insulin within 6 months of diagnosis)
Diabetes duration < 30 years (impaired awareness of hypoglycemia increases with duration so it will be more likely that shorter duration participants will have hypoglycemia awareness) but > 2 years (to ensure that they have lost hypoglycemia induced glucagon secretion as is typical in patients who develop impaired awareness of hypoglycemia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2
Awards & highlights

Study Summary

This trial is testing if naloxone, given through the nose, will help preserve the body's response to low blood sugar the next day in people with type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Epinephrine Levels
Change in Symptom Score

Side effects data

From 2017 Phase 4 trial • 570 Patients • NCT02032433
13%
Gastrointestinal
10%
Psychiatric
10%
Nervous system disorders
8%
Infections and infestations
6%
Injury, poisoning and procedural complications
6%
Injury poisoning and procedural complications
6%
Musculoskeletal and connective tissue disorders
4%
Investigations
4%
General Disorders and Administration Site Conditions
3%
Skin and subcutaneous tissue disorders
2%
Metabolism and nutrition
2%
Eye disorders
2%
Respiratory, thoracic, and mediastinal disorders
2%
Respiratory, thoracic and mediastinal disorders
1%
Renal and urinary disorders
1%
Reproductive system and breast disorders
1%
General disorders and administration site conditions
100%
80%
60%
40%
20%
0%
Study treatment Arm
Extended-Release Naltrexone
Buprenorphine-Naloxone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Naloxone, then placebo
Group II: 2Placebo Group1 Intervention
Placebo, then Naloxone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone then placebo
2017
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,367 Previous Clinical Trials
1,587,473 Total Patients Enrolled
Elizabeth Seaquist, MDPrincipal InvestigatorUniversity of Minnesota
4 Previous Clinical Trials
339 Total Patients Enrolled

Frequently Asked Questions

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

Why is Naloxone given to patients so often?

"Naloxone is most frequently used as an antidote for opioid overdoses. However, it can also be given to relieve symptoms like pain, itching, and septic shock."

Answered by AI

Could I possibly qualify to take part in this research?

"Currently, this clinical trial has 36 open slots for patients that have diabetes and an autoimmune disease. To be eligible, participants must also fall between the ages of 18-65."

Answered by AI

Does this trial have an age limit?

"Eligibility for this particular clinical trial requires that patients are aged 18 to 65. However, if the patient does not meet these age requirements, there are still 168 trials and 247 trials respectively that might be a better fit."

Answered by AI

Are there other examples of Naloxone being used in a clinical setting?

"As of now, there are 41 Naloxone studies that are ongoing with 10 in Phase 3. Out of the 126 study locations for Naloxone, several are based in Durham, North carolina."

Answered by AI

Is there a potential for Naloxone to be harmful?

"There is some data suggesting that Naloxone is safe, but none to support that it is effective. It received a score of 2."

Answered by AI

How many volunteers are taking part in this research?

"The listed trial is no longer recruiting patients. The initial posting was on September 18th, 2017 with the most recent edit on June 20th, 2022. There are presently 426 trials actively enrolling patients with diabetes and 41 for Naloxone that are still recruiting participants."

Answered by AI

Are currently-enrolled patients being sought for this research?

"This trial is not currently looking for new participants. The study was first posted on September 18th, 2017 and was last updated on June 20th, 2022. If you are interested in other studies, there are 426 clinical trials actively recruiting participants with diabetes and 41 studies for Naloxone that are currently looking for patients."

Answered by AI
~5 spots leftby Mar 2025