A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

• Status: Completed
• Trial end date: 2018-05-25
• Target enrollment: 0
• Participant gender: All

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 insulin-induced hypoglycemia. Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma
• Treatments: Glucagon

Criteria

Inclusion Criteria:

• 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 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