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Trial · Interventional

CompletedPhase 1/2Registry data

A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

NCTNCT03981627 (opens ClinicalTrials.gov in a new tab)Other idCT038-ADO09
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
44 participants (actual)
Sponsor
Adocia · Industry
Design
Randomized · Triple masking
Countries
1 country

Germany

Start
6 Jun 2019
Primary completion
27 Jun 2020
Completion
27 Jun 2020
First posted
11 Jun 2019
Last update posted
30 Nov 2020
Conditions
Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 1/2

    A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

    NCT03981627

    6 Jun 2019 to 27 Jun 2020

Registry summary

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

This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.

Interventions

  • ADO09 formulationDrug
  • NovoRapid®Drug

Arms2

  • Experimental

    Co-formulation of insulin analog and pramlintide (ADO09)

    Subcutaneous injection of ADO09 formulation

  • Active comparator

    NovoRapid®

    Subcutaneous injection of insulin aspart

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. ΔAUCPG(0-4h)

    Time frame · From 0 to 4 hours

    Registry description

    Incremental area under the plasma glucose concentration-time curve from 0-4 hours after start of breakfast, assessed by Super GL at day 24.

Secondary outcomes(4)

  1. Pharmacokinetics of pramlintide

    Time frame · From 0 to 4 hours

    Registry description

    Area under the pramlintide concentration-time curve

  2. Pharmacokinetics of insulins

    Time frame · From 0 to 4 hours

    Registry description

    Area under the insulins concentration-time curve

  3. Plasma glucose control as measured by CGM

    Time frame · Over 24 hours

    Registry description

    Time and percentage of time in Range (TiR) \[70-180\] mg/dL

  4. Safety and tolerability (Adverse Events recording)

    Time frame · Up to 24 days

    Registry description

    Number of Adverse Events

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

11 results

A co-formulation of pramlintide and insulin A21G (ADO09) improves postprandial glucose and short-term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes.

Andersen et al. 2023Diabetes, obesity & metabolismcited by 7

PMID 36633505DOI 10.1111/dom.14972PUB-36633505

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Signed and dated informed consent obtained before any trial-related activities. * Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months. * Treated with insulin ≥ 12 months. * Using a multiple dosing insulin therapy (MDI) with basal and bolus insulin. * HbA1c ≤ 9.0%. * Fasting negative C-peptide (≤ 0.30 nmol/L). * Total daily prandial dose: ≤ 40U in the Part A and ≥ 40 U in the Part B Exclusion Criteria: * Known or suspected hypersensitivity to products used in the clinical trial * Type 2 diabetes mellitus * Previous participation in this trial. Participation is defined as randomized. * Receipt of any medicinal product in clinical development within 3 months before randomization in this trial. * Known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption. * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator. * Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening.

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