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Type 1 Diabetes MellitusPhase 1/2NCT03981627

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

A Phase 1/2 study testing ADO09 formulation and NovoRapid® in people with Type 1 Diabetes Mellitus, run by Adocia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
ADO09 formulation and NovoRapid®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteGermany
Study dates
6 Jun 2019to 27 Jun 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Randomized, Single-centre, Double-blind, 2-period Cross-over Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

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.

Read the detailed description

After a screening visit, eligible subjects will enter a run-in period. Subjects will receive a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study. Each eligible subject will then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections of ADO09 and insulin aspart during 2 dosing periods. At Day 1 a mixed meal test (MMT) will be conducted at breakfast and subjects will remain at the clinical site until day 3. At Day 3 subjects will leave the clinical site and continue the treatment with IMP for the next 3 weeks. On Day 23 subjects will come back for a MMT on Day 24.

This study is constituted of 2 parts. In the first part (Part A), only subjects with daily prandial insulin dose ≤ 40 U/day will be enrolled.

Following the completion of the part A, an extension part (Part B) will be conducted to particularly assess the safety and tolerability of higher daily doses of ADO09 in patients with insulin requirements ≥ 40 U/day.

The clinical conduct and procedures will not change for the Extension Part of the study.

Being tested
ADO09 formulation, NovoRapid®
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADO09 formulationDrug

    Subcutaneous injection of ADO09 formulation

  • NovoRapid®Drug

    Subcutaneous injection of insulin aspart

Study groups in NCT03981627
Study groupRoleWhat they receive
Co-formulation of insulin analog and pramlintide (ADO09)ExperimentalSubcutaneous injection of ADO09 formulation
Receives: Drug: ADO09 formulation
NovoRapid®Active comparatorSubcutaneous injection of insulin aspart
Receives: Drug: NovoRapid®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ΔAUCPG(0-4h)

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

    Measured: From 0 to 4 hours

Secondary outcomes (4)

  1. Pharmacokinetics of pramlintide

    Area under the pramlintide concentration-time curve

    Measured: From 0 to 4 hours

  2. Pharmacokinetics of insulins

    Area under the insulins concentration-time curve

    Measured: From 0 to 4 hours

  3. Plasma glucose control as measured by CGM

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

    Measured: Over 24 hours

  4. Safety and tolerability (Adverse Events recording)

    Number of Adverse Events

    Measured: Up to 24 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2019
  2. Study start6 Jun 2019
  3. Primary completion27 Jun 2020
  4. Study completion27 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981627
Sponsor's protocol ID
CT038-ADO09
Status last verified
Nov 2020
First submitted
7 Jun 2019
Last updated
30 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Andersen G, Eloy R, Famulla S, Heise T, Meiffren G, Seroussi C, Gaudier M, Megret C, Chan YP, Soula O, Riddle M. 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. Diabetes Obes Metab. 2023 May;25(5):1241-1248. doi: 10.1111/dom.14972. Epub 2023 Jan 31.

    PubMed 36633505

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ADO09 formulation and NovoRapid® in people with Type 1 Diabetes Mellitus, run by Adocia at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ΔAUCPG(0-4h) (time frame: From 0 to 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03981627, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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