Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon

Phase 2 Completed 81 enrolled Zealand Pharma

RandomizedCrossoverDouble-blindTreatment

Summary

The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as compared to marketed glucagon.

Timeline

Start: 2016-01
Primary completion: 2016-06
Completion: 2016-06

Publications

Hovelmann U, Bysted BV, Mouritzen U, Macchi F, Lamers D, Kronshage B, Moller DV, Heise T. Pharmacokinetic and Pharmacodynamic Characteristics of Dasiglucagon, a Novel Soluble and Stable Glucagon Analog. Diabetes Care. 2018 Mar;41(3):531-537. doi: 10.2337/dc17-1402. Epub 2017 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dasiglucagon	Peptide	0.1 mg	Subcutaneous
Subject	Dasiglucagon	Peptide	0.3 mg	Subcutaneous
Subject	Dasiglucagon	Peptide	0.6 mg	Subcutaneous
Subject	Dasiglucagon	Peptide	1 mg	Subcutaneous
Comparator	Glucagon	Peptide	0.5 mg	Subcutaneous
Comparator	Glucagon	Peptide	1 mg	Subcutaneous

Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon

Summary

Timeline

Publications

Drugs

Indications