Adults with growth hormone disease (AGHD).
Conditions
Interventions
Trade Name: Norditropin® SimpleXx® 5 mg/1.5ml
Pharmaceutical Form: Injection*
CAS Number: 9002726
Other descriptive name: GROWTH HORMONE
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
Medical Department M (Endocrinology & Diabetes)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent 2. AGHD male or female subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II 3. Stable GH replacement therapy for at least 3 months 4. Body Mass Index (BMI, kg/m2) from 18,5 to 35.0 kg/m2, both inclusive 5. Achieved final height 6. Age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. AGHD subjects with active malignancy 2. Severe cardiac insufficiency classified according to NYHA III-IV 3. Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months 4. Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg 5. HbA1C > 7,5 % 6. Impaired kidney function: serum creatinine = 150 umol/l according to the hospital lab. 7. Patients on insulin treatment 8. Stable pituitary replacement therapy for less than 3 months 9. Participation in any other clinical trial involving any investigational products within the last three months prior to this trial 10. Any diseases judged by the investigator that could affect the trial 11. 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, intrauterine device (IUD), hysterectomy or sterilization 12. Known or suspected allergy to the trial product or ingredients of the trial product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To compare PK profiles of 3 mg/subject/day GH (Norditropin® SimpleXx®) administrated sc as an infusion in the patients with AGHD during interval exercise or in supine rest. 2. To compare pharmacodynamic (PD) effect of 3 mg/subject/day GH (Norditropin® SimpleXx®) administrated either as a single sc injection or as a sc infusion and combined with or without interval exercise in the patients with AGHD. 3. To compare the response of insulin and glucose in AGHD patients after intake of a standard carbohydrate rich breakfast in the bolus as well as in the infusion group ;Primary end point(s): Pharmacokinetic profiles of the individual hGH plasma concentration curves in treatment sessions with a single sc bolus injection without/with interval exercise ;Main Objective: To compare the pharmacokinetic (PK) profiles of 3 mg/subject/day Norditropin® SimpleXx® administrated SC as a bolus in the patients with AGHD during interval exercise or in supine rest. | — |
Countries
Denmark
Outcome results
None listed