Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02217800 (opens ClinicalTrials.gov in a new tab)Other idDG3173-II-02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
8 participants (actual)
Sponsor
Aspireo Pharmaceuticals Limited · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
Nov 2013
Primary completion
Mar 2014
Completion
May 2016
First posted
15 Aug 2014 (estimated)
Last update posted
15 Feb 2018
Conditions
Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 2

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

    NCT02217800

    Nov 2013 to May 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • salineDrug
  • DG3173Drug
  • octreotideDrug

Arms1

  • Other

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 23 hours following each treatment

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.

GroupValue (participants with trough hGH < 2.5 µg/mL)
Saline (Control)0
920 µg DG31731
2760 µg DG31732
5520 µg DG31733
Active Control (Octreotide)4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Saline (Control)–0 / 81 / 8
920 µg DG3173–0 / 81 / 8
2760 µg DG3173–0 / 82 / 8
5520 µg DG3173–0 / 82 / 8
Active Control (Octreotide)–0 / 81 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.