Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypoglycemia, Diabetes Mellitus, Type 1

In brief

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

Key facts

Study ID

NCT03688711

Run by

Zealand Pharma

People needed

45

Starts

2018-11-01

Expected to finish

2019-03-11

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).
• Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
• Hemoglobin A1c <10%.
• Aged between 18 and 75 years, both inclusive.

You may not qualify if…

• Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.
• Known or suspected allergy to trial drug(s) or related products.
• History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).
• Previous participation in this trial. Participation being defined by signing the informed consent document.

Where it is running

• ProSciento, Inc. — Chula Vista, California, United States
• AMCR Institute — Escondido, California, United States
• Rainier Clinical Research, Inc. — Renton, Washington, United States

Full record on ClinicalTrials.gov

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