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Diabetes Mellitus, Type 2Phase 3PIONEER STARTNCT05444153

Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity

A Phase 3 study testing Semaglutide and Empagliflozin in people with 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Withdrawn

Withdrawn.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

This study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide and Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
6 Oct 2022to 29 Aug 2025
Phase
Phase 3
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female, age 18- less than (<) 50 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus less than or equal to (<=) 365 days from the day of screening.
  • Glycated haemoglobin (HbA1c) of 7.0-9.5 percentage (%) (53-80 millimoles per milliliter [mmol/mol]) (both inclusive).
  • Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per meter square (kg/m^2).
  • Treatment naïve to any antidiabetic drug(s). However, for a subset of participants (≤25%) any metformin dose or formulations administered is allowed.

Who cannot join

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria since diagnosed with type 2 diabetes mellitus. Prior insulin treatment for gestational diabetes is allowed.
  • Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 60 milliliter per minute per 1.73 meter square (1.7mL/min/1.73 m^2) at screening.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • C-peptide less than (<)1.5 nanograms per milliliter (ng/mL) at screening.
  • Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
  • History of major surgical procedures involving the stomach or small intestine potentially affecting absorption of drugs and/or nutrients.
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

About this study

Official title: Efficacy and Safety of Early Initiation of Oral Semaglutide 50 mg Once Daily Versus Empagliflozin 25 mg Once Daily in Younger Patients With Newly Diagnosed Type 2 Diabetes and Obesity

This study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. Participants will either get semaglutide tablets or empagliflozin tablets. Which treatment participants get is decided by chance. Participants will get one tablet per day for 2 years. The study will last for about 2 years and 8 weeks.

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.

  • SemaglutideDrug

    Participants will receive 1 tablet of oral semaglutide once daily.

  • EmpagliflozinDrug

    Participants will receive 1 tablet of empagliflozin once daily.

Study groups in NCT05444153
Study groupRoleWhat they receive
Oral semaglutideExperimentalParticipants will receive once daily oral semaglutide tablet for 104 weeks in a dose escalation fashion of 3milligrams (mg), 7mg, 14 mg and 25 mg once every four weeks during the first 16 weeks and a maintenance dose of 55 mg for the rest 88 weeks.
Receives: Drug: Semaglutide
EmpagliflozinActive comparatorParticipants will receive once daily empagliflozin tablet for up to 104 weeks, starting with a dose of 10 mg for the first 8 weeks and the maintenance dose of 25 mg for the rest 96 weeks.
Receives: Drug: Empagliflozin

What is being measured

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

  1. Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No)

    Measured as count of participants.

    Measured: At week 104

  2. Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)

    Measured as count of participants.

    Measured: At week 104

Secondary outcomes (21)

  1. Change in HbA1c

    Measured as percentage (%)-point.

    Measured: From randomisation (week 0) to week 104

  2. Change in fasting plasma glucose (FPG)

    Measured in millimoles per liter (mmol/l).

    Measured: From randomisation (week 0) to week 104

  3. Change in self-measured plasma glucose (SPMG) 7-point mean profile

    Measured in millimoles per liter(mmol/l).

    Measured: From randomisation (week 0) to week 104

  4. Change in self-measured plasma glucose (SPMG) mean post prandial increments

    Measured in millimoles per liter(mmol/l).

    Measured: From randomisation (week 0) to week 104

  5. Time to additional anti-diabetic medication

    Measured in days.

    Measured: From randomisation (week 0) to week 104

  6. Change in body weight

    Measured in kilograms (kg).

    Measured: From randomisation (week 0) to week 104

  7. Relative change in body weight

    Measured as percentage (%).

    Measured: From randomisation (week 0) to week 104

  8. Change in waist circumference

    Measured in centimeters (cm).

    Measured: From randomisation (week 0) to week 104

  9. Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No)

    Measured as count of participants.

    Measured: From randomisation (week 0) to week 104

  10. Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No)

    Measured as count of participants.

    Measured: From randomisation (week 0) to week 104

  11. Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%)

    Measured as count of participants.

    Measured: From randomisation (week 0) to week 104

  12. Change in systolic blood pressure

    Measured in millimiters of mercury (mmHg).

    Measured: From randomisation (week 0) to week 104

  13. Change in total cholesterol

    Measured as ratio to baseline.

    Measured: From randomisation (week 0) to week 104

  14. Change in high density lipoprotein (HDL)

    Measured as ratio to baseline.

    Measured: From randomisation (week 0) to week 104

  15. Change in low density lipoprotein (LDL)

    Measured as ratio to baseline.

    Measured: From randomisation (week 0) to week 104

  16. Change in very low density lipoprotein (VLDL)

    Measured as ratio to baseline.

    Measured: From randomisation (week 0) to week 104

  17. Change in Triglycerides

    Measured as ratio to baseline.

    Measured: From randomisation (week 0) to week 104

  18. Change in free fatty acids

    Measured as ratio to baseline.

    Measured: From randomisation (week 0) to week 104

  19. Number of treatment emergent adverse events

    Measured as count of events.

    Measured: From randomisation (week 0) to week 109

  20. Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain

    Measured as score on a scale. Scales range from 0 (minimum) to 10 (maximum).

    Measured: From randomisation (week 0) to week 104

  21. Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina

    Measured as score on a scale. Scales range from 0 (minimum) to 10(maximum).

    Measured: From randomisation (week 0) to week 104

Timeline

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

  1. First posted5 Jul 2022
  2. Study start6 Oct 2022 (estimated)
  3. Primary completion2 Oct 2024 (estimated)
  4. Study completion29 Aug 2025 (estimated)

Why it stopped: Sponsor decision

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444153
Sponsor's protocol ID
NN9924-4668
Other IDs
U1111-1270-0763, 2021-005396-39
Acronym
PIONEER START
Status last verified
Nov 2022
First submitted
29 Jun 2022
Last updated
14 Nov 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?

A Phase 3 study testing Semaglutide and Empagliflozin in people with 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 5 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: withdrawn, as of the sponsor's last update on 14 Nov 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 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?

Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No) (time frame: At week 104). The study lists 2 primary outcomes in all. 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 NCT05444153.

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 14 Nov 2022.

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