Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)

Phase 2

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Norditropin SimpleXx (growth hormone)

• Registration Number: NCT01090778
• Lead Sponsor: Aarhus University Hospital

Brief Summary

This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions:A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously

Detailed Description

The subjects will attend a screening visit and four treatment sessions. The dosing visits will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay for the infusion group.

Study Timeline

• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Study Start: 2010-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• AGHD male or female subjects
• Stable GH replacement therapy for at least 3 months
• Body Mass Index 18,5 to 35.0 kg/m2
• Achieved final height
• Age ≥ 18 years

Exclusion Criteria

• Known or suspected allergy to trial product or components of the trial product
• Subjects with active malignancy
• Severe cardiac insufficiency classified according to NYHA III-IV
• Unstable angina pectoris, acute myocardial infarction within the last 12 months
• Severe, uncontrolled hypertension: sitting blood pressure > 180/110 mmHg
• HbA1C > 7,5 %
• Impaired kidney function: plasma creatinine ≥ 150 umol/l according to the hospital lab.
• Impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab.
• Patients on insulin treatment
• Stable pituitary replacement therapy for less than 3 months
• Participation in any other clinical trial involving any investigational products within the last three months prior to this trial
• Any diseases judged by the investigator that could affect the trial
• Women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. Women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, IUD or who had not undergone hysterectomy or sterilization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Norditropin SimpleXx single sc injection	Norditropin SimpleXx (growth hormone)	Single sc bolus injection of 3 mg growth hormone with interval exercise
Norditropin SimpleXx sc bolus injection	Norditropin SimpleXx (growth hormone)	Single sc bolus injection of 3 mg growth hormone without interval exercise
Norditropin SimpleXx contin. sc infusion	Norditropin SimpleXx (growth hormone)	Continuous sc infusion of 3 mg growth hormone without interval exercise
Norditropin SimpleXx cont. sc infusion	Norditropin SimpleXx (growth hormone)	Continuous sc infusion of 3 mg growth hormone with interval exercise

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profiles of growth hormone	48 hours	Pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as a bolus in the adult patients with growth hormone deficiency during interval exercise or in supine rest.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profiles of growth hormone	60 hours	To compare pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as an infusion in the adult patients with growth hormone deficiency during interval exercise or in supine rest.

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark

Medical Department M, Aarhus University Hospital; 🇩🇰 Aarhus C, Central Denmark Region, Denmark