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

NCT02660008 | Completed Phase 2

• 1 other identifier: ZP4207-15126
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (5)

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

  At visit 2 and 3

  During visit 2 and 3 (0-360min)

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

  At visit 2 and 3

  During visit 2 and 3 (0-360min)

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

  At visit 2 and 3

  During visit 2 and 3 (0-360min)

• PK endpoint: Peak plasma concentration (Cmax)

  At visit 2 and 3

  During visit 2 and 3 (0-360min)

• PK endpoint: Time to peak plasma concentration (tCmax)

  At visit 2 and 3

  During visit 2 and 3 (0-360min)

Secondary Outcomes (15)

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

  During visit 2 and 3 (0-30min)

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

  During visit 2 and 3 (0-360min)

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

  During visit 2 and 3 (0-30min)

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

  During visit 2 and 3 (0-360min)

• PK endpoints: Baseline adjusted glucagon profiles 0-360 min

  During visit 2 and 3 (0-360min)

Study Arms (2)

ZP4207

EXPERIMENTAL

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

Drug: ZP4207

GlucaGen

ACTIVE COMPARATOR

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

Drug: GlucaGen

Interventions

ZP4207 DRUG

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

ZP4207

GlucaGen DRUG

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

GlucaGen

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• 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.

  PMID: 29273578 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Interventions

Glucagon-Like Peptide 1; Glucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ulrike Hövelmann, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

DE (1)