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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.

NCTNCT02235987 (opens ClinicalTrials.gov in a new tab)Other idDG3173-II-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
20 participants (actual)
Sponsor
Aspireo Pharmaceuticals Limited · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
Oct 2012
Primary completion
Dec 2012
Completion
Apr 2014
First posted
10 Sept 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
2012201320142015
  1. Ph 2

    Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.

    NCT02235987

    Oct 2012 to Apr 2014

Registry summary

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

The study is designed to investigate the safety, tolerability and efficacy of DG3173 in untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and one dose of octreotide, the current gold standard of medical therapy for acromegaly, with each patient receiving all doses of DG3173 as well as octreotide.

Interventions

  • octreotideDrug
  • DG3173Drug

Arms1

  • Other

    Octreotide, then ascending DG3173

    Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Participants With Trough Human Growth Hormone < 2.5 ug/mL

    Time frame · Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.

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· Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.

Participants With Trough Human Growth Hormone < 2.5 ug/mL

GroupValue (participants with trough hGH < 2.5 µg/mL)
Baseline (Untreated Control)1
300 µg Octreotide8
100 µg DG31734
300 µg DG31736
900 µg DG31737
1800 µg DG31738

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
300 µg Octreotide–0 / 201 / 20
100 µg DG3173–0 / 200 / 20
300 µg DG3173–0 / 201 / 20
900 µg DG3173–0 / 190 / 19
1800 µg DG3173–0 / 191 / 19

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 childbearing potential or women of child bearing potential who either abstain from sexual intercourse, have a sterile partner or practice a medically approved double barrier method of contraception * Diagnosis of acromegaly of pituitary origin * Have age adjusted Insulin like Growth Factor 1 (IGF-1) concentrations ≥1.5 times the upper limit of normal range on two consecutive measurements in the 6 months prior to the first dosing day (including the measurement to be made at screening \[Visit 2\]) * Have a random hGH level of ≥5 µg/L in the 6 months prior to or at screening (Visit 2) * Have given written informed consent * Ability to comply with the requirements of the protocol of the study Exclusion Criteria: * Previous specific treatment for acromegaly in the 6 months prior to screening (Visit 2), including somatostatin analogues (SSAs), surgery, radiotherapy and pegvisomant * Treatment with dopamine agonists in the 3 months prior to screening (Visit 2) * Uncontrolled hypertension or orthostatic hypotension * 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 (Visit 2) * Receipt of blood, blood products or plasma derivatives 60 days prior to screening (Visit 2) * Pregnancy or lactation * 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 * Any clinically significant abnormal 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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