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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial

NCTNCT03596450 (opens ClinicalTrials.gov in a new tab)Other idNN9535-4416Other idU1111-1207-6474
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Overview

Status
Completed
Phase
Phase 4
Enrollment
1,278 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

United States, Canada

Start
13 Jul 2018
Primary completion
9 Jun 2022
Completion
9 Jun 2023
First posted
23 Jul 2018
Last update posted
30 Sept 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021202220232024
  1. Ph 4

    Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial

    NCT03596450

    13 Jul 2018 to 9 Jun 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable). The participant has an equal chance of being in either of the treatment groups. Neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. The study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. The participation will last about 2 years.

Interventions

  • SemaglutideDrug
  • Standard of careDrug

Arms2

  • Experimental

    Semaglutide

    Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

  • Active comparator

    Standard of care

    Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)

    Time frame · At year 1

    Registry description

    Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 1; No: number of participants who did not achieve HbA1c less than 7.0 % at year 1.

Secondary outcomes(20)

  1. Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1

    Time frame · Baseline (less than or equal to 90 days prior to randomization at week 0), year 1

    Registry description

    Change in HbA1c from baseline to year 1 is presented in %-point.

  2. Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No)

    Time frame · At year 2

    Registry description

    Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 2; No: number of participants who did not achieve HbA1c less than 7.0 % at year 2.

  3. Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2

    Time frame · Baseline (less than or equal to 90 days prior to randomization at week 0), year 2

    Registry description

    Change in HbA1c from baseline to year 2 is presented in percentage-point.

  4. Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No)

    Time frame · At year 1

    Registry description

    Number of participants who attained individualized HbA1c target at year 1 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 1; No: number of participants who did not achieve individualized HbA1c target attained at year 1

  5. Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No)

    Time frame · At year 1

    Registry description

    Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1

  6. Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No)

    Time frame · At year 1

    Registry description

    Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 1 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 1; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 1

  7. Change in Body Weight (in Pounds) From Baseline to Year 1

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1

    Registry description

    Change in body weight (in pounds) from baseline to year 1 is presented.

  8. Percentage Change in Body Weight From Baseline to Year 1

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1

    Registry description

    Percentage change in body weight from baseline to year 1 is presented.

  9. Change in Systolic Blood Pressure (SBP) From Baseline to Year 1

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1

    Registry description

    Change in SBP from baseline to year 1 is presented.

  10. Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1

    Registry description

    Change in DBP from baseline to year 1 is presented.

  11. Time to First Study Drug Discontinuation During 2 Years

    Time frame · Week 0 to year 2

    Registry description

    Time to first study drug discontinuation during 2 years is presented. First study drug discontinuation=date of the first time a patient is not taking study drug as defined.

  12. Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years

    Time frame · Week 0 to year 2

    Registry description

    Time to first treatment intensification (add-on) or change (switch) after randomization during 2 years is presented.

  13. Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study

    Time frame · Week 0 to year 1

    Registry description

    Percentage of MPR for study drug medication adherence for the first year of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills\*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment.

  14. Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

    Registry description

    Number of hypoglycemic episodes leading to an inpatient admission or emergency room (ER) encounter from baseline to year 2 is presented.

  15. Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1

    Time frame · At year 1

    Registry description

    DTSQc total treatment satisfaction score measured at year 1 is presented. 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.

  16. DTSQc, Total Treatment Satisfaction Score Measured at Year 2

    Time frame · At year 2

    Registry description

    DTSQc total treatment satisfaction score measured at year 2 is presented. 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.

  17. Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1

    Registry description

    Change from baseline in SF-12 v2, PCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.

  18. Change From Baseline in SF-12 v2, PCS-12 Score at Year 2

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2

    Registry description

    Change from baseline in SF-12 v2, PCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.

  19. Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1

    Registry description

    Change from baseline in SF-12 v2, MCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.

  20. Change From Baseline in SF-12 v2, MCS-12 Score at Year 2

    Time frame · Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2

    Registry description

    Change from baseline in SF-12 v2, MCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· At year 1

Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)

GroupValue (Participants)
Semaglutide244
Standard of Care226
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (less than or equal to 90 days prior to randomization at week 0), year 1

Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1

GroupValue (Percentage-point of HbA1c)Spread
Semaglutide-1.461.669
Standard of Care-1.141.707
Secondary outcomeCount of participants· At year 2

Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No)

GroupValue (Participants)
Semaglutide209
Standard of Care162
Secondary outcomeMean· Baseline (less than or equal to 90 days prior to randomization at week 0), year 2

Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2

GroupValue (Percentage-point of HbA1c)Spread
Semaglutide-1.451.723
Standard of Care-0.981.767
Secondary outcomeCount of participants· At year 1

Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No)

GroupValue (Participants)
Semaglutide216
Standard of Care170
Secondary outcomeCount of participants· At year 1

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No)

GroupValue (Participants)
Semaglutide321
Standard of Care301
Secondary outcomeCount of participants· At year 1

Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No)

GroupValue (Participants)
Semaglutide64
Standard of Care53
Secondary outcomeMean· Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1

Change in Body Weight (in Pounds) From Baseline to Year 1

GroupValue (Pounds (lbs))Spread
Semaglutide-9.821.15
Standard of Care-5.420.70

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SemaglutideParticipants received semaglutide subcutaneous (s.c.) injection once weekly in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants.9 / 63438 / 6340 / 634
Standard of CareParticipants received standard of care (any commercially available oral or injectable antidiabetic medication, excluding semaglutide) in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants.9 / 62139 / 6210 / 621

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

9 results

Long-term comparative effectiveness of once-weekly semaglutide versus alternative treatments in a real-world US adult population with type 2 diabetes: a randomized pragmatic clinical trial.

Buse et al. 2025BMJ open diabetes research & carecited by 3

PMID 41093600PMC12530410DOI 10.1136/bmjdrc-2025-005161PUB-41093600

Free to read · publisher termsCC BY-NC9 results
Read at sourceSee results (9)

More studies

1 study on this page

PubMed tag: none · 2023

Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial.

Buse et al. 2023BMJ open diabetes research & carecited by 17

PMID 37137527PMC10163526DOI 10.1136/bmjdrc-2022-003206PUB-37137527

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:- * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study. * Male or female, age 18 years or older at the time of signing informed consent. * Type 2 diabetes mellitus diagnosis. * Treatment with either 1 or 2 oral antidiabetic medications. * Current member of a commercial or Medicare health plan with pharmacy benefits. * Recorded HbAlc value within the last 90 days prior to randomization. * Further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling. Exclusion Criteria: * Previous randomization in this study * Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes. * Contraindications to semaglutide according to the Food and Drug Administration approved label. * Female who is pregnant, breastfeeding or intends to become pregnant * Participation in another clinical trial.

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