A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
Status: | Completed |
---|---|
Conditions: | Endocrine, Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 6/6/2018 |
Start Date: | December 7, 2017 |
End Date: | May 25, 2018 |
A Phase 3, Randomized, Double-blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus Compared to Placebo and With Reference to GlucaGen
The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo
following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus
with insulin-induced hypoglycemia. Additionaly to compare the glycemic response observed
after administration dasiglucagon with that of GlucaGen®.
following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus
with insulin-induced hypoglycemia. Additionaly to compare the glycemic response observed
after administration dasiglucagon with that of GlucaGen®.
Inclusion Criteria:
- Female or male subjects with T1DM for at least 1 year, diagnostic criteria as defined
by the American Diabetes Association
- 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%
Exclusion Criteria:
- Previously treated with dasiglucagon (previously referred to as ZP4207)
- Known or suspected allergy to trial product(s) or related products
- Females who are pregnant according to a positive pregnancy test, are actively
attempting to get pregnant, or are lactating.
- History of hypoglycemic events associated with seizures in the last year prior to
screening
- History of severe hypoglycemia in the last month prior to screening
- Active malignancy within the last 5 years
- Current bleeding disorder, including anti-coagulant treatment
- Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
(i.e. insulin secreting pancreas tumor)
- Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic
drugs in the previous 28 days before Day 1 of this trial
- Clinically significant abnormal ECG at screening as judged by the investigator
- Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks
prior to screening
- Surgery or trauma with significant blood loss within the last 2 months prior to
screening
- A positive result in the alcohol and/or urine drug screen at the screening visit.
Significant history of alcoholism or drug abuse as judged by the investigator or
consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day
for women
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