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Trial · Interventional

CompletedPhase 2Registry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
81 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
Jan 2016
Primary completion
Jun 2016
Completion
Jun 2016
First posted
21 Jan 2016 (estimated)
Last update posted
15 Jun 2016 (estimated)
Conditions
Hypoglycemia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017
  1. Ph 2

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

    NCT02660008

    Jan 2016 to Jun 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ZP4207Drug
  • GlucaGenDrug

Arms2

  • Experimental

    ZP4207

    ZP4207 (peptide analogue of human glucagon) Planned doses: 0.1, 0.3, 0.6, 1.0 mg s.c.

  • Active comparator

    GlucaGen

    GlucaGen (native glucagon) Planned doses: 0.5, 1.0 mg s.c.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. PD endpoint: Plasma glucose profiles 0-360 min above baseline (Area under the effect curve 0-360 min)

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3

  2. PD endpoint: Time to peak plasma glucose concentration (tmax)

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3

  3. PK endpoint: Plasma ZP4207 and glucagon profiles 0-360 min

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3

  4. PK endpoint: Peak plasma concentration (Cmax)

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3

  5. PK endpoint: Time to peak plasma concentration (tCmax)

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3

Secondary outcomes(15)
  1. PD endpoints: Percentage of patients achieving a plasma glucose concentration ≥70 mg/dL within 30 minutes after treatment

    Time frame · During visit 2 and 3 (0-30min)

    Registry description

    At visit 2 and 3

  2. PD endpoints: Time to plasma glucose concentration of ≥70 mg/dL

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3

  3. PD endpoints: Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL within 30 minutes after treatment

    Time frame · During visit 2 and 3 (0-30min)

    Registry description

    At visit 2 and 3,

  4. PD endpoints: Time to plasma glucose increase of ≥20 mg/dL

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3,

  5. PK endpoints: Baseline adjusted glucagon profiles 0-360 min

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3,

  6. PK endpoints: AUC0-inf for plasma ZP4207 concentration

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3, Area under the plasma curve from 0 to infinity

  7. Exploratory endpoint: Insulin concentrations

    Time frame · During visit 2 and 3 (0-360min)

    Registry description

    At visit 2 and 3, insulin concentrations in serum

  8. Exploratory endpoint: Changes in hypoglycaemic symptom scores from 0-30 minutes

    Time frame · During visit 2 and 3 (0-30min)

    Registry description

    At visit 2 and 3

  9. Safety and Tolerability: Number of participants with adverse events

    Time frame · Through study completion (up to 63 days)

    Registry description

    Number of participants with adverse events

  10. Safety and Tolerability: Changes or findings from baseline in physical examination

    Time frame · Through study completion (up to 63 days)

    Registry description

    An examination of the following body systems will be performed: * Head, ears, eyes, nose, throat (HEENT), incl. thyroid gland * Heart, lung, chest * Abdomen * Skin and mucosae * Musculoskeletal system * Nervous system * Lymph node * Other findings

  11. Safety and Tolerability: Changes or findings from baseline (normal ranges) in clinical safety laboratory parameters

    Time frame · Through study completion (up to 63 days)

    Registry description

    Haematology biochemistry, and urinalysis

  12. Safety and Tolerability: Changes or findings from baseline in vital signs

    Time frame · Through study completion (up to 63 days)

    Registry description

    systolic/diastolic blood pressure (mmHg) and heart rate (beats per minute), body temperature (°C), respiratory frequency (RF/min)

  13. Safety and Tolerability: Changes or findings from baseline in ECG

    Time frame · Through study completion (up to 63 days)

    Registry description

    Heart rate, PQ, QRS, QT, QTcB

  14. Safety and Tolerability: Local tolerability of injection site

    Time frame · Through study completion (up to 63 days)

    Registry description

    Findings in local tolerability by means of the following assessments. * spontaneous pain * pain on palpation * itching * redness * oedema * induration/infiltration * other

  15. Safety and Tolerability: Immunogenicity (Ant-Drug Antibody sampling)

    Time frame · Through study completion (up to 63 days)

    Registry description

    Antidrug antibodies incidences

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

16 results

Pharmacokinetic and Pharmacodynamic Characteristics of Dasiglucagon, a Novel Soluble and Stable Glucagon Analog.

Hövelmann et al. 2018Diabetes carecited by 84

PMID 29273578DOI 10.2337/dc17-1402PUB-29273578

Full text at the publisher16 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient). 2. Male and female patients with T1D for at least one year, as defined by the American Diabetes Association. 3. Having been treated with insulin for T1D for at least 1 year. 4. Stable disease with HbA1c \< 8.5%. 5. Expected stable insulin treatment during participation in trial and 3 month prior to the screening visit. 6. Age between 18 and 50 years, both inclusive. 7. Body weight between 60 and 90 kg, both inclusive. 8. Patients in good health according to age (medical history, physical examination, vital signs, ECG, lab assessments), as judged by the Investigator. \- Exclusion Criteria: 1. Previously treated with ZP4207. 2. Known or suspected allergy to trial product(s) or related products. 3. Previous participation (randomization) in this trial. 4. Receipt of any investigational drug within 3 months prior to screening. 5. A history or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, psychiatric diseases, or other major diseases. 6. Clinically significant illness within 4 weeks before screening, as judged by the Investigator. 7. History of, or positive results to the screening test for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies 8. Positive result of test for HIV antibodies. 9. Any clinically significant abnormal hematology, biochemistry or urinalysis screening tests, as judged by the Investigator. 10. Clinically significant abnormal ECG at screening as evaluated by the Investigator. 11. Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening. 12. A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug screen, or who consumes more than 14 units of alcohol per week (one unit of alcohol equals about 250 mL of beer, 1 glass of wine, or 20 mL of spirits). 13. Habitual smoking, i.e., daily smoking or more than 7 cigarettes/week within the last 3 months prior to screening. Patients have to accept refraining from smoking while at the clinical site. 14. Patients with mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the Investigator should not participate in the trial. 15. Surgery or trauma with significant blood loss within the last 2 months prior to screening. 16. Any condition interfering with trial participation or evaluation or that could be hazardous to the patient. 17. Severe hypoglycaemic events within one year prior to screening, as judged by the Investigator. 18. Significant changes in basal insulin within 3 weeks before screening, as judged by the Investigator. 19. Clinically relevant diabetic complications (macrovascular disease with symptoms or signs of coronary artery disease or peripheral vascular disease, microvascular disease with symptoms or signs of neuropathy, gastroparesis, retinopathy, nephropathy, or poor blood glucose control with polyuria, polydipsia, or weight loss), as judged by the Investigator. 20. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods (highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner) or postmenopausal women being amenorrheic for less than 1 year with serum FSH level \<= 40 IU/L and not using highly effective contraceptive methods during the trial and until one month after completion of the trial. 21. Male who is sexually active and not surgically sterilized who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures include surgical sterilisation, hormonal intrauterine devices \[coil\], oral hormonal contraceptives, each in combination with spermicide-coated condoms), or who is not willing to refrain from sexual intercourse from the first dosing until one month after last dosing in the trial.

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