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 | 
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
			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.
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