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



Status:Completed
Conditions:Endocrine, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:3/16/2019
Start Date:November 1, 2018
End Date:March 11, 2019

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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

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


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
3
sites
Renton, Washington 98057
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855 3rd Avenue
Chula Vista, California 91911
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Chula Vista, CA
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Escondido, California 92026
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Escondido, CA
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