NCT02916251

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

Randomised, Sequential, Cross-over Trial Assessing PK and PD Responses After Micro-doses of ZP4207 Administered s.c. to Patients With T1D Under eu- and Hypoglycemic Conditions and With Reference to Freshly Reconstituted Lyophilized Glucagon

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Detailed description

Seventeen (17) adult patients with T1DM treated with continuous subcutaneous insulin infusion (insulin pumps, CSII) will be randomized and take part at four dosing visits. The dosing visits are separated by 3-7 days. For the three lowest dose levels (0.03 mg, 0.08 mg, and 0.2 mg) the patients will receive two doses of ZP4207(dasiglucagon) (the first at euglycaemic and the second at hypoglycaemic conditions) and one dose of glucagon at euglycaemic conditions at visit 2-4. The first two dose administrations (Day 1, visit 2-4) will be separated by at least five hours. The third dose, which is ZP4207(dasiglucagon) during hypoglycemia, will for all dosing visits be administered the next morning after a standardized carbohydrate-rich meal in the evening before. The patients will stay at the clinical site over night between Day 1 and Day 2. The dose of 0.6 mg will only be administered for ZP4207(dasiglucagon). The order of the micro-dose levels as well as the order of the treatment, ZP4207(dasiglucagon) vs. glucagon, will be randomized. For all patients the 0.6 mg dose of ZP4207(dasiglucagon) will be administered at visit 5. For each dose level there will be 2 sets of PK/PD profiles for ZP4207(dasiglucagon), one initiated during euglycaemia and another during hypoglycaemia. Each patient enrolled will therefore provide a total of 11 PK/PD profiles covering four different dose levels; 8 profiles from ZP4207(dasiglucagon) and 3 profiles from glucagon

Conditions

• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
DRUG	ZP4207(dasiglucagon) glucagon analogue	Cross-over design with single s.c. administration in euglycemic and hypoglycemic T1D
DRUG	Glucagon (Native glucagon)	Cross-over design with single s.c. administration in euglycemic T1D

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-04-05
• Completion: 2017-04-05
• First posted: 2016-09-27
• Last updated: 2017-04-21

Locations

1 site across 1 country: Germany