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

Zealand Pharma

Status and phase: Completed; Phase 3

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Treatments: Drug: Dasiglucagon; Drug: Placebo; Drug: GlucaGen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03378635

ZP4207-16137

Details and patient eligibility

About

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®.

Full 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 patients were randomized 2:1:1 to receive a single subcutaneous 0.6 mg dose of dasiglucagon, placebo, or a 1 mg dose of GlucaGen and followed for at least 28 days after receiving treatment.

Enrollment: 170 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 3 patient groups, including a placebo group

Dasiglucagon

Experimental group

Description:

Single fixed dose (s.c.injection) of dasiglucagon

Treatment:

Drug: Dasiglucagon

Placebo

Placebo Comparator group

Description:

Single fixed dose (s.c.injection) of placebo

Treatment:

Drug: Placebo

GlucaGen®

Active Comparator group

Description:

Single fixed dose (s.c.injection) of GlucaGen®

Treatment:

Drug: GlucaGen