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

NCT03895697 | Completed Phase 3

• 1 other identifier: ZP4207-17084
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Keywords

glucagon

Outcome Measures

Primary Outcomes (1)

• Time to plasma glucose recovery

  Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous glucose

  0-45 minutes after dosing

Secondary Outcomes (18)

• Plasma glucose changes from baseline

  0-30 minutes after dosing

• Pharmacodynamics - Area under the effect curve 30 min

  0-30 minutes after dosing

• Pharmacodynamics - Area under the effect curve 90 min

  0-90 minutes after dosing

• Pharmacodynamics - Maximum plasma glucose concentration

  0-90 minutes after dosing

• Pharmacodynamics - Time maximum plasma glucose concentration

  0-90 minutes after dosing

Study Arms (2)

Dasiglucagon batch A crossover to dasiglucagon batch B

EXPERIMENTAL

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

Drug: dasiglucagon

Dasiglucagon batch B crossover to dasiglucagon batch A

EXPERIMENTAL

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

Drug: dasiglucagon

Interventions

dasiglucagon DRUG

Glucagon analogue

Also known as: ZP4207

Dasiglucagon batch A crossover to dasiglucagon batch B; Dasiglucagon batch B crossover to dasiglucagon batch A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

LMC Diabetes & Manna Research

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stine J Maarbjerg, PHD

  Zealand Pharma A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: March 26, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CA (1)