NCT03688711

Brief Summary

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

September 25, 2018

Results QC Date

March 26, 2021

Last Update Submit

April 28, 2021

Conditions

HypoglycemiaDiabetes Mellitus, Type 1

Keywords

glucagon

Outcome Measures

Primary Outcomes (1)

  • Time to Plasma Glucose Recovery.

    Plasma glucose recovery was 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 (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes.

    0-45 minutes after dosing

Secondary Outcomes (11)

  • Plasma Glucose Recovery After Trial Drug Injection

    0-30 minutes after dosing

  • Plasma Glucose Changes From Baseline

    0-30 minutes after dosing

  • Time to Target Plasma Glucose Concentration

    0-45 minutes after dosing

  • Pharmacodynamics - Area Under the Effect Curve

    0-30 minutes after dosing

  • Pharmacokinetics - Area Under the Plasma Concentration Curve

    0-90 minutes after dosing

  • +6 more secondary outcomes

Study Arms (2)

Dasiglucagon

EXPERIMENTAL

single fixed dose (subcutaneous injection) of dasiglucagon

Drug: Dasiglucagon

Placebo

PLACEBO COMPARATOR

single fixed dose (subcutaneous injection) of placebo

Drug: Placebo

Interventions

DasiglucagonDRUG

Glucagon analogue

Also known as: ZP4207
Dasiglucagon
PlaceboDRUG

Placebo for dasiglucagon

Also known as: Placebo for dasiglucagon
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).
  • 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%.
  • Aged between 18 and 75 years, both inclusive.

You may not qualify if:

  • Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.
  • Known or suspected allergy to trial drug(s) or related products.
  • History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).
  • Previous participation in this trial. Participation being defined by signing the informed consent document.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ProSciento, Inc.

Chula Vista, California, 91911, United States

Location

AMCR Institute

Escondido, California, 92025, United States

Location

Rainier Clinical Research, Inc.

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

HypoglycemiaDiabetes Mellitus, Type 1

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Dr Kim Mark Knudsen
Organization
Zealand Pharma A/S
KMKnudsen@zealandpharma.com
+4550603780

Study Officials

  • Christina M Sylvest, MSc Pharm

    Zealand Pharma A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 28, 2018

Study Start

November 1, 2018

Primary Completion

March 11, 2019

Study Completion

March 11, 2019

Last Updated

May 19, 2021

Results First Posted

May 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)