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Dasiglucagon Batch Comparison in T1DM
NCT03895697Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2019
- Primary completion
- Jul 2019
- Countries
- 1
- Sponsor
- Zealand Pharma
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- dasiglucagon
- Conditions
- hypoglycemia
01
Overview
Phase 3, randomised, double-blind trial of dasiglucagon in hypoglycemia (2 arms), sponsored by Zealand Pharma. Primary endpoint: Time to plasma glucose recovery. Started Mar 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sequence AB
Batch A then Batch B
Sequence BA
Batch B then Batch A
03
Who it enrols
Adult patients with Type 1 Diabetes Mellitus for at least 1 year, on stable insulin therapy, with HbA1c < 10.0%, excluding those with recent severe hypoglycemia or seizures.
04
Endpoints
Primary
Time to plasma glucose recovery
Secondary
Plasma glucose changes from baseline
Area under the effect curve 30 min
Maximum plasma glucose concentration
Pharmacokinetics - Area under the plasma concentration-time curve
Pharmacokinetics - Maximum plasma concentration
Adverse events
Occurrence of anti-drug antibodies
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