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Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes (PIONEER PLUS)

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ClinicalTrials.gov Identifier: NCT04707469
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Oral semaglutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : August 11, 2022
Estimated Study Completion Date : March 7, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Oral semaglutide 50 mg
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68).
Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

Experimental: Oral semaglutide 25 mg
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68).
Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

Active Comparator: Oral semaglutide 14 mg
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68).
Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.




Primary Outcome Measures :
  1. Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 52 ]
    %-point


Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: From baseline (week 0) to week 52 ]
    kg

  2. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to week 52 ]
    mmol/L

  3. Achievement of HbA1c below 7% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants

  4. Achievement of HbA1c equal to or below 6.5% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants

  5. Relative change in body weight [ Time Frame: From baseline (week 0) to week 52 ]
    Percentage (%)

  6. Change in waist circumference [ Time Frame: From baseline (week 0) to week 52 ]
    cm

  7. Achievement of weight loss equal to or above 5% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants

  8. Achievement of weight loss equal to or above 10% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants

  9. Adverse events [ Time Frame: From baseline (week 0) to follow-up visit (week 73) ]
    Count of events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
  • HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
  • BMI equal to or above 25 kg/m^2
  • Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
  • No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:

    • Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
    • Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
    • Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
  • Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
  • Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).

Exclusion Criteria:

  • Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
  • Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707469


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04707469    
Other Study ID Numbers: NN9924-4635
U1111-1247-0210 ( Other Identifier: World Health Organization (WHO) )
2020-000299-39 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases