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CompletedNCT02660008Updated Jun 15, 2016

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

A Phase 2 interventional study of ZP4207 and GlucaGen in Hypoglycemia, sponsored by Zealand Pharma. Completed at 1 site in Germany. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-06-15.

Sponsored by Zealand Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study 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.

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Conditions studied

  • Hypoglycemia

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In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 81 is above the median of 29 across 471 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

-

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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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    ZP4207

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

    Drug: ZP4207

  • Active comparator
    GlucaGen

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

    Drug: GlucaGen

Interventions

  • DrugZP4207

    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

    Also known as: analogue af human glucagon

  • DrugGlucaGen

    Parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of GlucaGen administered s.c. to hypoglycemic Type 1 diabetic patients

    Also known as: glucagon

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What researchers measure

Primary outcomes

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

    At visit 2 and 3

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

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

    At visit 2 and 3

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

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

    At visit 2 and 3

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

  4. PK endpoint: Peak plasma concentration (Cmax)

    At visit 2 and 3

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

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

    At visit 2 and 3

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

Secondary outcomes

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

    At visit 2 and 3

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

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

    At visit 2 and 3

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

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

    At visit 2 and 3,

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

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

    At visit 2 and 3,

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

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

    At visit 2 and 3,

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

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

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

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

  7. Exploratory endpoint: Insulin concentrations

    At visit 2 and 3, insulin concentrations in serum

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

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

    At visit 2 and 3

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

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

    Number of participants with adverse events

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

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

    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

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

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

    Haematology biochemistry, and urinalysis

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

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

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

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

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

    Heart rate, PQ, QRS, QT, QTcB

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

  14. Safety and Tolerability: Local tolerability of injection site

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

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

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

    Antidrug antibodies incidences

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

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Study locations

1 site
  • Profil Institut für Stoffwechselforschung GmbH
    Neuss, 41460, Germany
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References and documents

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. PubMed 29273578 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02660008
Lead sponsor
Zealand Pharma
Responsible party
Sponsor
First posted
Jan 21, 2016
Start date
Jan 2016
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jun 15, 2016

Study contacts

Ulrike Hövelmann, MD
principal investigator · Profil Institut für Stoffwechselforschung GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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