Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02916251

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

Diabetes Mellitus Type 1 Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02916251
Study type Interventional
Source Zealand Pharma
Contact
Status Completed
Phase Phase 2
Start date December 1, 2016
Completion date April 5, 2017
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT01508065 - Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
Completed NCT01788033 - Effects of XOMA 052 on Insulin Production in Type 1 Diabetes Phase 2
Active, not recruiting NCT01271517 - Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis Phase 4
Recruiting NCT01800734 - Mixed Meal Test in Type 1 Diabetes: Optimization of Artificial Pancreas-Pilot Study Phase 4
Recruiting NCT06088615 - Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry
Completed NCT02127047 - Effects of Exercise and Inhibition of Dipeptidyl Peptidase-4 on Insulin Secretion in Subjects With Type 1 Diabetes Phase 2
Completed NCT01689090 - Diameter Changes of Retinal Vessels During Hypoxia N/A
Completed NCT00006505 - Solitary Islet Transplantation for Type 1 Diabetes Mellitus Using Steroid Sparing Immunosuppression Phase 2
Not yet recruiting NCT06217302 - Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease Phase 3
Recruiting NCT02750111 - Continuous Glucose Monitoring During Intecorse in Young Adults With Type 1 Diabetes N/A
Recruiting NCT02545062 - MoCa Test for the Early Detection of Mild Cognitive Impairment During Annual Assessment of Young Adults With Diabetes and in a Control Group Without Diabetes N/A
Completed NCT02146651 - A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes Phase 2
Completed NCT02538120 - Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients N/A
Completed NCT02403375 - Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes N/A
Terminated NCT00896610 - Natural History of Autoimmune Diabetes and Its Complications
Terminated NCT02701257 - The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas N/A
Completed NCT02094534 - A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics Phase 2
Completed NCT01334151 - Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Phase 1
Active, not recruiting NCT02624804 - A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes Phase 1
Completed NCT02465411 - Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections N/A