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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Semaglutide
Empagliflozin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Oral semaglutide

    Empagliflozin

    Arm Description

    Participants 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.

    Participants 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.

    Outcomes

    Primary Outcome Measures

    Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No)
    Measured as count of participants.
    Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)
    Measured as count of participants.

    Secondary Outcome Measures

    Change in HbA1c
    Measured as percentage (%)-point.
    Change in fasting plasma glucose (FPG)
    Measured in millimoles per liter (mmol/l).
    Change in self-measured plasma glucose (SPMG) 7-point mean profile
    Measured in millimoles per liter(mmol/l).
    Change in self-measured plasma glucose (SPMG) mean post prandial increments
    Measured in millimoles per liter(mmol/l).
    Time to additional anti-diabetic medication
    Measured in days.
    Change in body weight
    Measured in kilograms (kg).
    Relative change in body weight
    Measured as percentage (%).
    Change in waist circumference
    Measured in centimeters (cm).
    Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No)
    Measured as count of participants.
    Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No)
    Measured as count of participants.
    Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%)
    Measured as count of participants.
    Change in systolic blood pressure
    Measured in millimiters of mercury (mmHg).
    Change in total cholesterol
    Measured as ratio to baseline.
    Change in high density lipoprotein (HDL)
    Measured as ratio to baseline.
    Change in low density lipoprotein (LDL)
    Measured as ratio to baseline.
    Change in very low density lipoprotein (VLDL)
    Measured as ratio to baseline.
    Change in Triglycerides
    Measured as ratio to baseline.
    Change in free fatty acids
    Measured as ratio to baseline.
    Number of treatment emergent adverse events
    Measured as count of events.
    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).
    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).

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    November 11, 2022
    Sponsor
    Novo Nordisk A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05444153
    Brief Title
    Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity
    Acronym
    PIONEER START
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision
    Study Start Date
    October 6, 2022 (Anticipated)
    Primary Completion Date
    October 2, 2024 (Anticipated)
    Study Completion Date
    August 29, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novo Nordisk A/S

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral semaglutide
    Arm Type
    Experimental
    Arm Description
    Participants 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.
    Arm Title
    Empagliflozin
    Arm Type
    Active Comparator
    Arm Description
    Participants 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Semaglutide
    Intervention Description
    Participants will receive 1 tablet of oral semaglutide once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Empagliflozin
    Intervention Description
    Participants will receive 1 tablet of empagliflozin once daily.
    Primary Outcome Measure Information:
    Title
    Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No)
    Description
    Measured as count of participants.
    Time Frame
    At week 104
    Title
    Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)
    Description
    Measured as count of participants.
    Time Frame
    At week 104
    Secondary Outcome Measure Information:
    Title
    Change in HbA1c
    Description
    Measured as percentage (%)-point.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in fasting plasma glucose (FPG)
    Description
    Measured in millimoles per liter (mmol/l).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in self-measured plasma glucose (SPMG) 7-point mean profile
    Description
    Measured in millimoles per liter(mmol/l).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in self-measured plasma glucose (SPMG) mean post prandial increments
    Description
    Measured in millimoles per liter(mmol/l).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Time to additional anti-diabetic medication
    Description
    Measured in days.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in body weight
    Description
    Measured in kilograms (kg).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Relative change in body weight
    Description
    Measured as percentage (%).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in waist circumference
    Description
    Measured in centimeters (cm).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No)
    Description
    Measured as count of participants.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No)
    Description
    Measured as count of participants.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%)
    Description
    Measured as count of participants.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in systolic blood pressure
    Description
    Measured in millimiters of mercury (mmHg).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in total cholesterol
    Description
    Measured as ratio to baseline.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in high density lipoprotein (HDL)
    Description
    Measured as ratio to baseline.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in low density lipoprotein (LDL)
    Description
    Measured as ratio to baseline.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in very low density lipoprotein (VLDL)
    Description
    Measured as ratio to baseline.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in Triglycerides
    Description
    Measured as ratio to baseline.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in free fatty acids
    Description
    Measured as ratio to baseline.
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Number of treatment emergent adverse events
    Description
    Measured as count of events.
    Time Frame
    From randomisation (week 0) to week 109
    Title
    Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain
    Description
    Measured as score on a scale. Scales range from 0 (minimum) to 10 (maximum).
    Time Frame
    From randomisation (week 0) to week 104
    Title
    Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina
    Description
    Measured as score on a scale. Scales range from 0 (minimum) to 10(maximum).
    Time Frame
    From randomisation (week 0) to week 104

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Transparency dept. 2834
    Organizational Affiliation
    Novo Nordisk A/S
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
    IPD Sharing URL
    http://novonordisk-trials.com

    Learn more about this trial

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

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