Back to resultsThe Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
saline
DG3173
octreotide
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Saline, then DG3173, then octreotide
Arm Description
Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02217800
First Posted
August 14, 2014
Last Updated
January 19, 2018
Sponsor
Aspireo Pharmaceuticals Limited
1. Study Identification
Unique Protocol Identification Number
NCT02217800
Brief Title
The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
Official Title
The Effect of Subcutaneous Infusions of 3 Doses of a Novel Somatostatin Analogue, DG3173, on Growth Hormone Levels in Untreated Acromegalics
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aspireo Pharmaceuticals Limited
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline, then DG3173, then octreotide
Arm Type
Other
Arm Description
Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
Intervention Type
Drug
Intervention Name(s)
DG3173
Intervention Description
Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
Intervention Type
Drug
Intervention Name(s)
octreotide
Intervention Description
Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
Primary Outcome Measure Information:
Title
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.
Time Frame
23 hours following each treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
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