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Dasiglucagon for Low Blood Sugar

Phase 3

Recruiting

Research Sponsored by Zealand Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured pre-dose (baseline) and 15 minutes after dosing on day 1

Awards & highlights

Study Summary

This trial will study if a single dose of medication is safe and works to treat low blood sugar in children aged 1-6. Participants will have 3 study visits over 84 days.

Who is the study for?

This trial is for children aged 1 to 6 with Type 1 Diabetes (T1D) who are on daily insulin therapy via a pump and weigh over 8 kg. It's not suitable for those allergic to the study drug or related products, have conditions affecting liver sugar stores, history of seizures due to low blood sugar, unawareness of hypoglycemia signs, or severe allergy history.Check my eligibility

What is being tested?

The study tests dasiglucagon as an emergency treatment for low blood sugar in young children with T1D. It involves a single dose given by injection under the skin and checks how well it works and its safety over three visits within up to 84 days.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar treatments may include reactions at the injection site, nausea, vomiting, headache or high blood sugar levels after use. The trial will monitor all potential side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have type 1 diabetes and use an insulin pump daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured pre-dose (baseline) and 15 minutes after dosing on day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured pre-dose (baseline) and 15 minutes after dosing on day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured pre-dose (baseline) and 15 minutes after dosing on day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous (IV) glucose

Secondary outcome measures

Plasma glucose change from baseline at 15 minutes after IMP injection or at the time of rescue by IV glucose

Side effects data

From 2018 Phase 3 trial • 170 Patients • NCT03378635

55%

Nausea

28%

Hypoglycemia

23%

Vomiting

12%

Headache

Nasopharyngitis

Diarrhea

Pharyngitis

Back pain

Injection site pain

Hyperglycaemia

Pain in extremity

Burning sensation

Pyrexia

Hot flush

Presyncope

Bradycardia

Seasonal allergy

Cough

Infusion site rash

Oropharyngeal pain

Asthenopia

Injection site erythema

Thrombophlebitis

Abdominal tenderness

Ketosis

Ear infection

Dysmenorrhea

Pollakiuria

100%

80%

60%

40%

20%

Study treatment Arm

Dasiglucagon 0.6 mg

Placebo

GlucaGen® 1.0 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dasiglucagon 0.6 mgExperimental Treatment1 Intervention

Participants will receive a single dose of dasiglucagon.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dasiglucagon

2021

Completed Phase 3

~390

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zealand PharmaLead Sponsor

37 Previous Clinical Trials

2,770 Total Patients Enrolled

Clinical OperationsStudy DirectorZealand Pharma A/S

19 Previous Clinical Trials

2,303 Total Patients Enrolled

Media Library

Dasiglucagon 0.6 mg Clinical Trial Eligibility Overview. Trial Name: NCT05378672 — Phase 3

Low Blood Sugar Research Study Groups: Dasiglucagon 0.6 mg

Low Blood Sugar Clinical Trial 2023: Dasiglucagon 0.6 mg Highlights & Side Effects. Trial Name: NCT05378672 — Phase 3

Dasiglucagon 0.6 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05378672 — Phase 3

Frequently Asked Questions

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

Are there any risks associated with Dasiglucagon 0.6 mg usage?

"Considering its Phase 3 trial status, there is substantial evidence that Dasiglucagon 0.6 mg is safe; thus, our team at Power allocates it a score of 3 on the safety scale."

Answered by AI

For whom is this clinical trial best suited?

"In order to qualify for this research project, potential participants must possess hypoglycemia and fit the age range of 1 year old to 5. The team is currently seeking 8 individuals that meet these criteria."

Answered by AI

Is this trial open to individuals aged 45 and above?

"The parameters for this clinical trial stipulate that children between 1 Year and 5 Years are the ideal applicants. Moreover, there are 12 studies tailored to individuals under 18 years of age as well as 58 studies targeting those above 65."

Answered by AI

Are there still opportunities to participate in this research?

"Per information available on clinicaltrials.gov, this study has begun seeking participants and is continuing to do so as of August 28th 2023. The trial was first posted on May 9th 2023."

Answered by AI

How many participants are being enrolled in this clinical trial?

"Indeed, the information published on clinicaltrials.gov suggests that recruitment for this trial is still ongoing. Initially posted on May 9th 2023 and last updated August 28th of the same year, 8 individuals need to be enlisted from two separate medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Inv. Safety,Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children<6 Years With T1D

2023. "A Study to Inv. Safety,Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children<6 Years With T1D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378672.

All > Hypoglycemia