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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04707469
Recruitment Status : Active, not recruiting
First Posted : January 13, 2021
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 12, 2021
First Posted Date  ICMJE January 13, 2021
Last Update Posted Date September 22, 2022
Actual Study Start Date  ICMJE January 15, 2021
Estimated Primary Completion Date March 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 52 ]
%-point
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Change in body weight [ Time Frame: From baseline (week 0) to week 52 ]
    kg
  • Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to week 52 ]
    mmol/L
  • Achievement of HbA1c below 7% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants
  • Achievement of HbA1c equal to or below 6.5% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants
  • Relative change in body weight [ Time Frame: From baseline (week 0) to week 52 ]
    Percentage (%)
  • Change in waist circumference [ Time Frame: From baseline (week 0) to week 52 ]
    cm
  • Achievement of weight loss equal to or above 5% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants
  • Achievement of weight loss equal to or above 10% (Yes/No) [ Time Frame: At week 52 ]
    Count of participants
  • Adverse events [ Time Frame: From baseline (week 0) to follow-up visit (week 73) ]
    Count of events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
Official Title  ICMJE Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
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®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Drug: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Oral semaglutide
  • 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).
    Intervention: Drug: Oral semaglutide
  • 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).
    Intervention: Drug: Oral semaglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2021)
1224
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 7, 2023
Estimated Primary Completion Date March 7, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   Germany,   Hungary,   India,   Poland,   Puerto Rico,   Slovakia,   Slovenia,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04707469
Other Study ID Numbers  ICMJE NN9924-4635
U1111-1247-0210 ( Other Identifier: World Health Organization (WHO) )
2020-000299-39 ( Registry Identifier: European Medicines Agency (EudraCT) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP