Status:
COMPLETED
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
Lead Sponsor:
Zealand Pharma
Conditions:
Hypoglycemia
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 (T1DM) with ins...
Detailed Description
This was a global, multicenter, randomized, parallel, and double-blind clinical trial confirming the efficacy and safety of dasiglucagon for insulin-induced hypoglycemia in patients with T1DM. The pat...
Eligibility Criteria
Inclusion
- Female or male subjects with type 1 diabetes mellitus (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
- 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
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2018
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03378635
Start Date
December 7 2017
End Date
May 25 2018
Last Update
June 10 2021
Active Locations (5)
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1
ProSciento
Chula Vista, California, United States, 91911
2
Clinical Research Center, Medizinische Universität Graz
Graz, Austria
3
LMC Diabetes & Manna Research
Toronto, Canada
4
Profil
Mainz, Germany