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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 T1DM treated with insulin

Investigation of Medications for Treating Low Blood Sugar (Hypoglycemia) Levels

Recruiting
6-17 years
All
Phase N/A

This study investigates the effectiveness of different medications in treating low blood sugar, also known as hypoglycemia. Hypoglycemia is a condition where blood sugar levels drop too low, which can be dangerous if not treated. The study aims to find the best treatment options for managing this condition in patients with Type 1 Diabetes Mellitus (T1DM).

Participants in the study will receive either an investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will involve regular monitoring of blood sugar levels and other health indicators to assess the effectiveness of the treatment.

  • Who can participate: Adults diagnosed with Type 1 Diabetes Mellitus (T1DM) according to the American Diabetes Association criteria, who have been on daily insulin for at least one year, can participate. Female participants must use accepted contraceptive methods if of childbearing potential, and male participants must use condoms if sexually active.
  • Study details: Participants will receive either an investigational medication or a placebo. Participants will be monitored regularly for changes in blood sugar levels and overall health.
Study details
    type 1 diabetes
    hypoglycemia

TX9404

19 February 2024

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