- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02660008
Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon
June 14, 2016 updated by: Zealand Pharma
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Neuss, Germany, 41460
- Profil Institut für Stoffwechselforschung GmbH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
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Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ZP4207
ZP4207 (peptide analogue of human glucagon) Planned doses: 0.1, 0.3, 0.6, 1.0 mg s.c.
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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
Other Names:
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Active Comparator: GlucaGen
GlucaGen (native glucagon) Planned doses: 0.5, 1.0 mg s.c.
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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At visit 2 and 3
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During visit 2 and 3 (0-360min)
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PD endpoint: Time to peak plasma glucose concentration (tmax)
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3
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During visit 2 and 3 (0-360min)
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PK endpoint: Plasma ZP4207 and glucagon profiles 0-360 min
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3
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During visit 2 and 3 (0-360min)
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PK endpoint: Peak plasma concentration (Cmax)
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3
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During visit 2 and 3 (0-360min)
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PK endpoint: Time to peak plasma concentration (tCmax)
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3
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During visit 2 and 3 (0-360min)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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At visit 2 and 3
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During visit 2 and 3 (0-30min)
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PD endpoints: Time to plasma glucose concentration of ≥70 mg/dL
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3
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During visit 2 and 3 (0-360min)
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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)
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At visit 2 and 3,
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During visit 2 and 3 (0-30min)
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PD endpoints: Time to plasma glucose increase of ≥20 mg/dL
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3,
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During visit 2 and 3 (0-360min)
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PK endpoints: Baseline adjusted glucagon profiles 0-360 min
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3,
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During visit 2 and 3 (0-360min)
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PK endpoints: AUC0-inf for plasma ZP4207 concentration
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3, Area under the plasma curve from 0 to infinity
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During visit 2 and 3 (0-360min)
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Exploratory endpoint: Insulin concentrations
Time Frame: During visit 2 and 3 (0-360min)
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At visit 2 and 3, insulin concentrations in serum
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During visit 2 and 3 (0-360min)
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Exploratory endpoint: Changes in hypoglycaemic symptom scores from 0-30 minutes
Time Frame: During visit 2 and 3 (0-30min)
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At visit 2 and 3
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During visit 2 and 3 (0-30min)
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Safety and Tolerability: Number of participants with adverse events
Time Frame: Through study completion (up to 63 days)
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Number of participants with adverse events
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Through study completion (up to 63 days)
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Safety and Tolerability: Changes or findings from baseline in physical examination
Time Frame: Through study completion (up to 63 days)
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An examination of the following body systems will be performed:
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Through study completion (up to 63 days)
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Safety and Tolerability: Changes or findings from baseline (normal ranges) in clinical safety laboratory parameters
Time Frame: Through study completion (up to 63 days)
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Haematology biochemistry, and urinalysis
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Through study completion (up to 63 days)
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Safety and Tolerability: Changes or findings from baseline in vital signs
Time Frame: Through study completion (up to 63 days)
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systolic/diastolic blood pressure (mmHg) and heart rate (beats per minute), body temperature (°C), respiratory frequency (RF/min)
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Through study completion (up to 63 days)
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Safety and Tolerability: Changes or findings from baseline in ECG
Time Frame: Through study completion (up to 63 days)
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Heart rate, PQ, QRS, QT, QTcB
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Through study completion (up to 63 days)
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Safety and Tolerability: Local tolerability of injection site
Time Frame: Through study completion (up to 63 days)
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Findings in local tolerability by means of the following assessments.
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Through study completion (up to 63 days)
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Safety and Tolerability: Immunogenicity (Ant-Drug Antibody sampling)
Time Frame: Through study completion (up to 63 days)
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Antidrug antibodies incidences
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Through study completion (up to 63 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
January 6, 2016
First Submitted That Met QC Criteria
January 16, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Estimate)
June 15, 2016
Last Update Submitted That Met QC Criteria
June 14, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZP4207-15126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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