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Diabetes Mellitus, Type 2PIONEER REALNCT05473286

A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 34-44 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Oral Semaglutide
How many people
0 participants
Where
No sites listed yet
Study dates
30 Sep 2022to 16 May 2024
Phase
Observational
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 years and older
  • All sexes
  • Adult, Older adult

Study population: Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Who may be able to join

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • Diagnosed with type 2 diabetes mellitus.
  • The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Available HbA1c value less than or equal to (≤) 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.
  • Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than (<) 14 days.

Who cannot join

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Treatment with any investigational drug within 30 days prior to enrolment into the study.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

About this study

Official title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Germany

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 34-44 weeks. Participants will be asked to complete questionnaires about how they take their Rybelsus® tablets. Participants will complete the questionnaires during their normally scheduled visit with the study doctor.

Being tested
Oral Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Oral SemaglutideDrug

    Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.

Study groups in NCT05473286
Study groupRoleWhat they receive
Patients with type 2 diabetesAdult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Receives: Drug: Oral Semaglutide

What is being measured

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

  1. Change in Glycated haemoglobin (HbA1c )

    Percent-points.

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

Secondary outcomes (7)

  1. Relative change in body weight

    Percent.

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

  2. Absolute change in body weight

    Kilogram (Kg).

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

  3. HbA1c <7% (Yes or No)

    Percentage of patients achieving or not achieving HbA1c <7% (Yes or No).

    Measured: End of Study visit (V3) (week 34-44)

  4. HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No)

    Percentage of patients achieving or not achieving HbA1c reduction >=1%-points and body weight reduction of >=5%.

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

  5. HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No)

    Percentage of patients achieving or not achieving HbA1c reduction >=1%-points and body weight reduction of >=3%.

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

  6. Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction

    The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.

    Measured: End of Study visit (V3) (week 34-44)

  7. Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction

    The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items.

    Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)

Timeline

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

  1. First posted25 Jul 2022
  2. Study start30 Sep 2022 (estimated)
  3. Primary completion16 May 2024 (estimated)
  4. Study completion16 May 2024 (estimated)

Why it stopped: Rybelsus® was not launched in Germany during the planned duration of NN9924-4540 study.

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473286
Sponsor's protocol ID
NN9924-4540
Acronym
PIONEER REAL
Status last verified
Sep 2022
First submitted
22 Jul 2022
Last updated
29 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.

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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change in Glycated haemoglobin (HbA1c ) (time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)). 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 NCT05473286.

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 29 Sep 2022.

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