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

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Norditropin SimpleXx (growth hormone)
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency focused on measuring growth hormone deficiency, circadian variation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Department M, Aarhus University Hospital
  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Norditropin SimpleXx sc bolus injection

Norditropin SimpleXx single sc injection

Norditropin SimpleXx contin. sc infusion

Norditropin SimpleXx cont. sc infusion

Arm Description

Single sc bolus injection of 3 mg growth hormone without interval exercise

Single sc bolus injection of 3 mg growth hormone with interval exercise

Continuous sc infusion of 3 mg growth hormone without interval exercise

Continuous sc infusion of 3 mg growth hormone with interval exercise

Outcomes

Primary Outcome Measures

Pharmacokinetic profiles of growth hormone
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

Pharmacokinetic profiles of growth hormone
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.

Full Information

First Posted
March 22, 2010
Last Updated
January 8, 2014
Sponsor
Aarhus University Hospital
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01090778
Brief Title
Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
Official Title
Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency
Keywords
growth hormone deficiency, circadian variation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norditropin SimpleXx sc bolus injection
Arm Type
Other
Arm Description
Single sc bolus injection of 3 mg growth hormone without interval exercise
Arm Title
Norditropin SimpleXx single sc injection
Arm Type
Other
Arm Description
Single sc bolus injection of 3 mg growth hormone with interval exercise
Arm Title
Norditropin SimpleXx contin. sc infusion
Arm Type
Other
Arm Description
Continuous sc infusion of 3 mg growth hormone without interval exercise
Arm Title
Norditropin SimpleXx cont. sc infusion
Arm Type
Other
Arm Description
Continuous sc infusion of 3 mg growth hormone with interval exercise
Intervention Type
Drug
Intervention Name(s)
Norditropin SimpleXx (growth hormone)
Other Intervention Name(s)
Norditropin® SimpleXx®
Intervention Description
3mg/subject/day over two consecutive days
Primary Outcome Measure Information:
Title
Pharmacokinetic profiles of growth hormone
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetic profiles of growth hormone
Description
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.
Time Frame
60 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Laursen, professor
Organizational Affiliation
Institute of Pharmacology, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department M, Aarhus University Hospital
City
Aarhus C
State/Province
Central Denmark Region
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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