Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
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ClinicalTrials.gov Identifier: NCT03688711 |
Recruitment Status :
Completed
First Posted : September 28, 2018
Results First Posted : May 19, 2021
Last Update Posted : May 19, 2021
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Sponsor:
Zealand Pharma
Information provided by (Responsible Party):
Zealand Pharma
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Hypoglycemia Diabetes Mellitus, Type 1 |
Interventions |
Drug: Dasiglucagon Drug: Placebo |
Enrollment | 45 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Dasiglucagon 0.6 mg | Placebo |
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single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue |
single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon |
Period Title: Overall Study | ||
Started [1] | 34 | 11 |
Completed | 34 | 10 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 1 |
[1]
Randomized
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Baseline Characteristics
Arm/Group Title | Dasiglucagon 0.6 mg | Placebo | Total | |
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single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue |
single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon |
Total of all reporting groups | |
Overall Number of Baseline Participants | 34 | 10 | 44 | |
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The safety population of all randomized subjects who received at least one dose of trial drug
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 34 participants | 10 participants | 44 participants | |
42.4 (13.49) | 36.5 (12.80) | 41.0 (13.42) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 34 participants | 10 participants | 44 participants | |
Female |
18 52.9%
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1 10.0%
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19 43.2%
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Male |
16 47.1%
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9 90.0%
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25 56.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 34 participants | 10 participants | 44 participants | |
Hispanic or Latino |
4 11.8%
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3 30.0%
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7 15.9%
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Not Hispanic or Latino |
30 88.2%
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7 70.0%
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37 84.1%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 34 participants | 10 participants | 44 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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1 10.0%
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1 2.3%
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Black or African American |
0 0.0%
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1 10.0%
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1 2.3%
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White |
34 100.0%
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7 70.0%
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41 93.2%
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More than one race |
0 0.0%
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1 10.0%
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1 2.3%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 34 participants | 10 participants | 44 participants |
34 100.0%
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10 100.0%
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44 100.0%
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Body weight
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 34 participants | 10 participants | 44 participants | |
84.49 (20.102) | 83.69 (10.812) | 84.30 (18.295) | ||
Body mass index
Mean (Standard Deviation) Unit of measure: Kg per square metre |
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Number Analyzed | 34 participants | 10 participants | 44 participants | |
28.41 (5.802) | 27.92 (3.975) | 28.30 (5.402) | ||
Duration of diabetes
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 34 participants | 10 participants | 44 participants | |
22.5 (13.82) | 21.2 (13.42) | 22.2 (13.59) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr Kim Mark Knudsen |
Organization: | Zealand Pharma A/S |
Phone: | +4550603780 |
EMail: | KMKnudsen@zealandpharma.com |
Responsible Party: | Zealand Pharma |
ClinicalTrials.gov Identifier: | NCT03688711 |
Other Study ID Numbers: |
ZP4207-17145 |
First Submitted: | September 25, 2018 |
First Posted: | September 28, 2018 |
Results First Submitted: | March 26, 2021 |
Results First Posted: | May 19, 2021 |
Last Update Posted: | May 19, 2021 |