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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2018-05-25

Brief Summary

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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®.

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Detailed Description

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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.

Conditions

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Hypoglycemia Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dasiglucagon

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

Group Type EXPERIMENTAL

Dasiglucagon

Intervention Type DRUG

Glucagon analog

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for dasiglucagon

GlucaGen®

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

Group Type ACTIVE_COMPARATOR

GlucaGen

Intervention Type DRUG

Native glucagon

Interventions

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Dasiglucagon

Glucagon analog

Intervention Type DRUG

GlucaGen

Native glucagon

Intervention Type DRUG

Placebo

Placebo for dasiglucagon

Intervention Type DRUG

Other Intervention Names

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ZP4207 GlucaGen HypoKit Placebo for dasiglucagon

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No