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Type 1 Diabetes MellitusPhase 2NCT04816890

A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)

A Phase 2 study testing M1 Pram P037 and Insulin lispro in people with Type 1 Diabetes Mellitus, run by Adocia at 2 sites 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

In this trial, the treatment of subjects with type 1 diabetes with M1 Pram P037 as co-formulation of pramlintide and A21G human insulin analogue product will be compared with a current standard treatment, insulin lispro. 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?
M1 Pram P037 and Insulin lispro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesGermany
Study dates
23 Mar 2021to 24 Feb 2022
Phase
Phase 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. Trial-related activities are any procedures that would not have been done during normal management of the subject.
  • Subjects with type 1 diabetes mellitus.
  • Body Mass Index (BMI) between 25.0 and 35.0 kg/m^2, both inclusive.
  • HbA1c between 7.0 % and 9.5 %, both inclusive.
  • Diabetes duration of at least 12 months.
  • Using a multiple dosing insulin therapy (MDI) with a basal insulin and a rapid-acting insulin at at least two meals per day.
  • Using any CGM or Flash Glucose Monitoring (FGM) for at least 1 month or willing to use CGM during the trial.

Who cannot join

  • Known or suspected hypersensitivity to IMPs or any of the excipients or to any component of the IMP formulation.
  • Type 2 diabetes mellitus.
  • Receipt of any medicinal product in clinical development within 3 months or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  • Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
  • Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
Show all 22Show fewer
  • Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg. One repeat test (on a different day, if necessary) will be acceptable in case of suspected white-coat hypertension.
  • Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
  • Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (<1.5 years) ophthalmologic examination.
  • Severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
  • More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
  • Hypoglycaemic unawareness as judged by the Investigator.
  • Hospitalisation for diabetic ketoacidosis during the previous 6 months.
  • Presence of clinically significant gastrointestinal symptoms (e.g., nausea, vomiting, heartburn or diarrhea), as judged by the Investigator.
  • Confirmed diagnosis of gastroparesis or requiring the use of drugs that alter gastrointestinal motility.
  • Unusual meal habits and special diet requirements that could constitute a risk for the subject when participating in the trial or interfere with the interpretation of data.
  • Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists within 4 weeks prior to screening.
  • Use of systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within 2 months prior to screening.
  • Use or planned use of drugs that promote weight loss (e.g. liraglutide, semaglutide, orlistat, lorcaserin, phentermine) within 2 months prior to screening.
  • If female, pregnancy or breast-feeding.
  • Women of childbearing potential who are not using a highly effective contraceptive method.
  • The Investigator considers a subject as unsuitable for inclusion in the study for any other reason.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Profil Mainz GmbH & Co

    Mainz, 55116

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in T1DM Subjects

In this trial, the treatment of subjects with type 1 diabetes with M1 Pram P037 as co-formulation of pramlintide and A21G human insulin analogue product will be compared with a current standard treatment, insulin lispro. During a four months treatment period doses in both treatment arms may be adjusted and optimised under outpatient conditions to allow a meaningful comparison of both treatments with respect to their effects on body weight, achievable glycaemic control, safety and tolerability, treatment satisfaction and well-being.

Read the detailed description

After a run in period in case of basal insulin switch or Continuous Glucose Monitoring (CGM) initiation, eligible subjects will enter a 3 weeks baseline recording period.

Subjects will then be randomized to either M1 Pram P037 treatment or active comparator treatment (insulin lispro). Both investigator and enrolled subjects will be unblinded to treatment. Study participants will use CGM until follow-up visit.

Treatment period will last 16 weeks. Throughout the 4-month treatment period, basal insulin and investigational products administration will be individually adjusted. Treatment Satisfaction Questionnaire and WHO-5 well-being index will be completed by subjects at day 0 and after 2 months (Visit 9) and 4 months (Visit 11) of treatment.

A safety follow-up visit, 7 to 14 days after the last administration of IMP, will mark the end of the clinical trial for the subjects.

Being tested
M1 Pram P037, Insulin lispro
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.

  • M1 Pram P037Drug

    Subcutaneous administration of M1 Pram P037 in combination with a basal insulin.

  • Insulin lisproDrug

    Subcutaneous administration of insulin lispro in combination with a basal insulin.

Study groups in NCT04816890
Study groupRoleWhat they receive
M1 Pram P037ExperimentalMulti daily administration of M1 Pram P037 by subcutaneous injection
Receives: Drug: M1 Pram P037
Insulin lisproActive comparatorMulti daily administration of insulin lispro (Humalog®) by subcutaneous injection
Receives: Drug: Insulin lispro

What is being measured

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

  1. Body weight change from baseline to week 16 of treatment

    Change in body weight after 16 weeks of treatment

    Measured: From week 0 to week 16

Secondary outcomes (15)

  1. TIR [70-180] mg/dL.

    Time In Range [70-180] mg/dL change from baseline to week 16 of treatment as measured by CGM.

    Measured: From week 0 to week 16

  2. %TIR [70-180] mg/dL.

    Percentage of Time In Range [70-180] mg/dL change from baseline to week 16 of treatment as measured by CGM.

    Measured: From week 0 to week 16

  3. TIR [70-140] mg/dL.

    Time In Range [70-140] mg/dL change from baseline to week 16 of treatment as measured by CGM.

    Measured: From week 0 to week 16

  4. %TIR [70-140] mg/dL.

    Percentage of Time In Range [70-140] mg/dL change from baseline to week 16 of treatment as measured by CGM.

    Measured: From week 0 to week 16

  5. MeanG_24h

    Average glucose over 24h change from baseline to week 16 of treatment

    Measured: From week 0 to week 16

  6. CVG_24h

    Coefficient Of Variation of glucose over 24h change from baseline to week 16 of treatment.

    Measured: From week 0 to week 16

  7. DistG_24h

    Distance travelled over 24h change from baseline to week 16 of treatment

    Measured: From week 0 to week 16

  8. SDG_24h

    Standard Deviation of all glucose values over 24h change from baseline to week 16 of treatment

    Measured: From week 0 to week 16

  9. HbA1c

    HbA1c change from baseline to week 16 of treatment

    Measured: From week 0 to week 16

  10. Total Insulin doses

    Change from baseline of total insulin doses

    Measured: From week 0 to week 16

  11. Prandial Insulin doses

    Change from baseline of prandial (per meal), insulin doses

    Measured: From week 0 to week 16

  12. Basal Insulin doses

    Change from baseline of basal insulin doses

    Measured: From week 0 to week 16

  13. Number of Adverse Events

    Number of Adverse Events observed during the treatment period

    Measured: From week 0 to week 16

  14. Duration of Adverse Events

    Duration of Adverse Events observed during the treatment period

    Measured: From week 0 to week 16

  15. Hypoglycaemic episodes

    Number of Hypoglycemic episodes during the 16 weeks treatment period

    Measured: From week 0 to week 16

Timeline

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

  1. First posted25 Mar 2021
  2. Study start23 Mar 2021
  3. Primary completion24 Feb 2022
  4. Study completion24 Feb 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04816890
Sponsor's protocol ID
CT041-ADO09
Status last verified
Jun 2022
First submitted
22 Mar 2021
Last updated
24 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andersen G, Eloy R, Heise T, Gaudier M, Megret C, Seroussi C, Chan YP, Soula O, Riddle M, DeVries JH. ADO09, a co-formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes. Diabetes Obes Metab. 2024 Oct;26(10):4639-4645. doi: 10.1111/dom.15827. Epub 2024 Aug 7.

    PubMed 39109464

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing M1 Pram P037 and Insulin lispro in people with Type 1 Diabetes Mellitus, run by Adocia at 2 sites 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 22 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 phase mean?

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?

Body weight change from baseline to week 16 of treatment (time frame: From week 0 to week 16). 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 NCT04816890, 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 24 Jun 2022.

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