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

Zealand Pharma1 个研究点分布在 1 个国家目标入组 81 人开始时间: 2016年1月最近更新: 2016年6月15日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Zealand Pharma
入组人数: 81
试验地点: 1
主要终点: PD endpoint: Plasma glucose profiles 0-360 min above baseline (Area under the effect curve 0-360 min)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•Previously treated with ZP
•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.

研究组 & 干预措施

ZP4207

Experimental

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

干预措施: ZP4207 (Drug)

GlucaGen

Active Comparator

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

干预措施: GlucaGen (Drug)

结局指标

主要结局

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