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drugset / Trial / NCT02916251

ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon

NCT02916251 ↗

Phase 2 Completed 38 enrolled Zealand Pharma
RandomizedCrossoverDouble-blindTreatment

Summary

The trial is a single-centre, randomised, sequential, cross-over trial assessing pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 (dasiglucagon\*) administered subcutaneously to patients with type 1 diabetes mellitus under euglycaemic and hypoglycaemic conditions and compared to marketed glucagon. \*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

Timeline

Start
2016-12-01
Primary completion
2017-04-05
Completion
2017-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dasiglucagon Peptide 0.03 mg Subcutaneous
Subject Dasiglucagon Peptide 0.08 mg Subcutaneous
Subject Dasiglucagon Peptide 0.2 mg Subcutaneous
Subject Dasiglucagon Peptide 0.6 mg Subcutaneous
Comparator Glucagon Peptide 0.03 mg Subcutaneous
Comparator Glucagon Peptide 0.08 mg Subcutaneous
Comparator Glucagon Peptide 0.2 mg Subcutaneous

Indications

type 1 diabetes mellitus