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

NCT02916251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-04-21

No results posted yet for this study

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

Conditions

  • Diabetes Mellitus Type 1

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Hövelmann Ulrike, MD · Profil Neuss GmbH Neuss, Germany, 41460

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916251 on ClinicalTrials.gov