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HypoglycemiaPhase 2NCT02660008

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 study testing ZP4207 and GlucaGen in people with Hypoglycemia, run by Zealand Pharma at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Hypoglycemia
What is being tested?
ZP4207 and GlucaGen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteGermany
Study dates
Jan 2016to Jun 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
  • Male and female patients with T1D for at least one year, as defined by the American Diabetes Association.
  • Having been treated with insulin for T1D for at least 1 year.
  • Stable disease with HbA1c < 8.5%.
  • Expected stable insulin treatment during participation in trial and 3 month prior to the screening visit.
  • Age between 18 and 50 years, both inclusive.
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  • Body weight between 60 and 90 kg, both inclusive.
  • Patients in good health according to age (medical history, physical examination, vital signs, ECG, lab assessments), as judged by the Investigator.
  • -

Who cannot join

  • Previously treated with ZP4207.
  • Known or suspected allergy to trial product(s) or related products.
  • Previous participation (randomization) in this trial.
  • Receipt of any investigational drug within 3 months prior to screening.
  • 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.
  • Clinically significant illness within 4 weeks before screening, as judged by the Investigator.
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  • History of, or positive results to the screening test for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies
  • Positive result of test for HIV antibodies.
  • Any clinically significant abnormal hematology, biochemistry or urinalysis screening tests, as judged by the Investigator.
  • Clinically significant abnormal ECG at screening as evaluated by the Investigator.
  • Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening.
  • 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).
  • 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.
  • 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.
  • Surgery or trauma with significant blood loss within the last 2 months prior to screening.
  • Any condition interfering with trial participation or evaluation or that could be hazardous to the patient.
  • Severe hypoglycaemic events within one year prior to screening, as judged by the Investigator.
  • Significant changes in basal insulin within 3 weeks before screening, as judged by the Investigator.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Randomized, Double-blind Trial of Single Doses of ZP4207 Administered s.c. to Hypoglycemic Type 1 Diabetic Patients to Describe the Pharmacokinetics and Pharmacodynamics of ZP4207 as Compared to Marketed Glucagon

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.

Conditions
Hypoglycemia
Being tested
ZP4207, GlucaGen
Medical subject headings
Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZP4207Drug

    Also called analogue af human glucagon

    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

  • GlucaGenDrug

    Also called glucagon

    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

Study groups in NCT02660008
Study groupRoleWhat they receive
ZP4207ExperimentalZP4207 (peptide analogue of human glucagon) Planned doses: 0.1, 0.3, 0.6, 1.0 mg s.c.
Receives: Drug: ZP4207
GlucaGenActive comparatorGlucaGen (native glucagon) Planned doses: 0.5, 1.0 mg s.c.
Receives: Drug: GlucaGen

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    At visit 2 and 3

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

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

    At visit 2 and 3

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

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

    At visit 2 and 3

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

  4. PK endpoint: Peak plasma concentration (Cmax)

    At visit 2 and 3

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

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

    At visit 2 and 3

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

Secondary outcomes (15)

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

    At visit 2 and 3

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

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

    At visit 2 and 3

    Measured: 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,

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

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

    At visit 2 and 3,

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

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

    At visit 2 and 3,

    Measured: 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

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

  7. Exploratory endpoint: Insulin concentrations

    At visit 2 and 3, insulin concentrations in serum

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

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

    At visit 2 and 3

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

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

    Number of participants with adverse events

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: Through study completion (up to 63 days)

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

    Heart rate, PQ, QRS, QT, QTcB

    Measured: 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

    Measured: Through study completion (up to 63 days)

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

    Antidrug antibodies incidences

    Measured: Through study completion (up to 63 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660008
Sponsor's protocol ID
ZP4207-15126
Status last verified
Jun 2016
First submitted
6 Jan 2016
Last updated
15 Jun 2016
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZP4207 and GlucaGen in people with Hypoglycemia, run by Zealand Pharma at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02660008, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.

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