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The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

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ClinicalTrials.gov Identifier: NCT02217800
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Aspireo Pharmaceuticals Limited

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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: saline Drug: DG3173 Drug: octreotide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Subcutaneous Infusions of 3 Doses of a Novel Somatostatin Analogue, DG3173, on Growth Hormone Levels in Untreated Acromegalics
Study Start Date : November 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Saline, then DG3173, then octreotide
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.
Drug: saline
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.

Drug: DG3173
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.

Drug: 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.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Aspireo Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT02217800    
Other Study ID Numbers: DG3173-II-02
First Posted: August 15, 2014    Key Record Dates
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents