CompletedPhase 3

Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

United States, Germany, Slovenia42 participantsStarted 2018-09-28

Plain-language summary

A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin

Who can participate

Age range6 Years – 17 Years

SexALL

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Inclusion criteria

✓. Following receipt of verbal and written information about the trial, patient, parent(s) or guardian(s) of the patient must provide signed informed consent before any trial-related activity is carried out
✓. Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association; and receiving daily insulin
✓. At least 6.0 years of age (inclusive) and less than 18.0 years
✓. Body weight ≥20 kg
✓. Female patients must meet one of the following criteria:
✓. Male patients must meet the following criteria: If sexually active, uses condom and partner practices contraception during the trial from screening and until last follow-up visit
✓. Willingness to adhere to the protocol requirements

What they're measuring

Time to Plasma Glucose Recovery

Timeframe: 0-45 minutes after dosing

Trial details

NCT IDNCT03667053

SponsorZealand Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-28

Results submitted2021-04-13

View on ClinicalTrials.gov More Hypoglycemia trials