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History of Changes for Study: NCT03688711
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Latest version (submitted April 28, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 27, 2018 None (earliest Version on record)
2 October 29, 2018 Outcome Measures, Study Status, Contacts/Locations, Conditions and Oversight
3 October 31, 2018 Outcome Measures and Study Status
4 November 2, 2018 Recruitment Status, Study Status and Contacts/Locations
5 November 7, 2018 Contacts/Locations and Study Status
6 March 13, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 March 10, 2020 Study Status
8 March 26, 2021
Quality Control Review has not concluded Returned: April 22, 2021
Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Document Section, Adverse Events, Baseline Characteristics, Participant Flow, IPDSharing and Study Description
9 April 28, 2021 Outcome Measures, Study Status
Comparison Format:

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Study NCT03688711
Submitted Date:  September 27, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: ZP4207-17145
Brief Title: Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2018
Overall Status: Not yet recruiting
Study Start: November 1, 2018
Primary Completion: March 18, 2019 [Anticipated]
Study Completion: April 18, 2019 [Anticipated]
First Submitted: September 25, 2018
First Submitted that
Met QC Criteria:
September 27, 2018
First Posted: September 28, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
September 27, 2018
Last Update Posted: September 28, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Zealand Pharma
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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
Detailed Description:
Open or close this module Conditions
Conditions: Hyperglycemia
Keywords: glucagon
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 46 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: dasiglucagon
single fixed dose (sc injection) of dasiglucagon
Drug: dasiglucagon
Glucagon analogue
Other Names:
  • ZP4207
Placebo Comparator: Placebo
single fixed dose (sc injection) of placebo
Drug: Placebo
Placebo for dasiglucagon
Other Names:
  • Placebo for dasiglucagon
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Time to plasma glucose recovery.
[ Time Frame: 0-45 minutes after dosing ]

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 IV
Secondary Outcome Measures:
1. Plasma glucose recovery after trial drug injection
[ Time Frame: 0-30 minutes after dosing ]

Plasma glucose recovery (patient has achieved increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L)) within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial drug injection without administration of rescue IV glucose.
2. Plasma glucose changes from baseline
[ Time Frame: 0-30 minutes after dosing ]

Plasma glucose changes from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial drug injection or at the time of rescue (patient level).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Lena S List
Telephone: +45 50603842
Email: lsl@zealandpharma.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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