A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2019-07-30

Brief Summary

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A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)

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Detailed Description

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This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose. To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.

Conditions

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Hypoglycemia Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dasiglucagon batch A crossover to dasiglucagon batch B

V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B

Group Type EXPERIMENTAL

dasiglucagon

Intervention Type DRUG

Glucagon analogue

Dasiglucagon batch B crossover to dasiglucagon batch A

V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A

Group Type EXPERIMENTAL

dasiglucagon

Intervention Type DRUG

Glucagon analogue

Interventions

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dasiglucagon

Glucagon analogue

Intervention Type DRUG

Other Intervention Names

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ZP4207

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association.
* Hemoglobin A1c \<10.0% at screening
* Treated with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening

Exclusion Criteria

* History of hypoglycemic events associated with seizures in the last year prior to screening
* History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening
* Previous participation in a clinical trial within the dasiglucagon program

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No