Join a Trial Testing Emergency Glucagon for Kids
Children with type 1 diabetes under the age of 6 may be eligible to participate in a trial testing dasiglucagon (Zegalogue) as a rescue therapy for low blood glucose.
Clinical Trials Identifier: NCT05378672
Trial Name: A Study to Investigate Safety, Efficacy & Pharmacodynamics of Dasiglucagon as Hypoglycemia Rescue Therapy in Children Under 6 Years With T1D
Diabetes Type: Type 1 diabetes
Trial Sponsor: Zealand Pharma
What is the aim of the trial?
This research study will investigate whether dasiglucagon (sold under the name Zegalogue) works as a rescue therapy and is safe to use in children under 6 years of age. In addition, the study will investigate how the medication works in the body.
How does the trial work?
A total of 8 children will be included in this phase 3 clinical trial. The study will last up to 84 days. The trial will include the following visits:
- A pre-treatment screening visit
- A dosing visit, which will involve a single dose of the investigational medication
- A safety follow-up visit
Participants will receive a single dose of dasiglucagon as an injection under the skin into the buttocks. Four of the children will receive a dose of 0.3 mg, and the other four children will receive a dose of 0.6 mg.
Researchers will observe various outcome measures throughout the process, including change in blood glucose levels from baseline at 30 minutes after injection or at the time of rescue by intravenous glucose (an IV drip of water and a sugar known as dextrose). Blood glucose levels will be measured at baseline, 15 minutes, and 30 minutes after dosing, while glucose levels will be monitored by continuous glucose monitor (CGM) and by a plasma glucose analyzer during the second visit. Safety will be assessed prior to dosing and throughout a 5-hour period after dosing and again at the follow-up visit.
Are you interested in participating?
Further inclusion criteria apply, but participants may be eligible if they:
- Are aged 5 or under at the time of screening and have been diagnosed with type 1 diabetes
- Are receiving daily insulin therapy via insulin pump or multiple daily injections
- Have a bodyweight greater than 17.7 pounds (8 kg)
Children who have a known or suspected allergy to the investigational therapy or related products, have a history of severe anaphylaxis or severe systemic allergy such as angioedema, or have a history of hypoglycemic (low blood glucose) events associated with seizures are not eligible to participate. Further exclusion criteria also apply; see a more detailed list here.
This study is currently actively recruiting in Connecticut, Georgia, Indiana, and Texas. To learn more about enrolling in this study, contact Zealand Pharma clinical operations at [email protected] or by phone at +45 88 77 36 00.
Further reading about treating hypoglycemia:
- Glucagon: Everything You Need to Know
- Join a Clinical Trial Investigating a New Medication to Prevent Nighttime Lows
- A Guide to Navigating Nighttime Hypoglycemia
Photo credit: Zealand Pharma