Phase 2
N=8
The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT02217800 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment. — 0; 1; 2; 3 participants with trough hGH < 2.5 µg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- saline (Drug); DG3173 (Drug); octreotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aspireo Pharmaceuticals Limited
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment. |
0; 1; 2; 3; 4 | — |
Summary
This study is designed to assess the effect of the different continuous s.c. infusion treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.
Eligibility Criteria
Inclusion Criteria
- Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception
- Diagnosis of acromegaly of pituitary origin
- Have an age-adjusted insulin-like growth factor type 1 (IGF-1) concentration ≥1.2 times the upper limit of normal range on at least one measurement in the 12 months prior to screening (Visit 1) AND a second raised value screening
- Have at least one random hGH level of ≥5 μg/L in the 12 months prior to screening AND a second raised value at screening
- Have given written informed consent
- Ability to comply with the requirements of the protocol for the study
Exclusion Criteria
- Previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (SSAs); surgery; radiotherapy and pegvisomant
- Treatment with dopamine agonists in the 3 months prior to screening
- Uncontrolled hypertension
- Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated haemoglobin [HbA1c] ≥7.5%) and patients requiring insulin treatment
- Gallstones or gravel that could cause biliary obstruction
- Hyperprolactinaemia
- Participation in a clinical study within 60 days prior to screening
- Receipt of blood, blood products or plasma derivatives 60 days prior to screening
- Body mass index (BMI) below 22 or above 37 kg/m2
- Pregnancy, lactation or use of any hormonal based contraceptives
- Concomitant intake of corticosteroids or levodopa
- A history of active alcohol abuse or drug addiction
- Positive viral serology screening result for hepatitis B surface antigen, antibodies to hepatitis C virus, or human immunodeficiency virus type 1 and 2
- Evidence or suspicion of tumour expansion
- Clinically significant abnormality in screening ECG in the opinion of the Investigator
- Any clinically significant abnormal in screening laboratory safety test (biochemistry, haematology and dipstick urinalysis) in the opinion of the Investigator
- Any disease which in the Investigator's opinion would exclude the patient from the study
Data sourced from ClinicalTrials.gov (NCT02217800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.