Trial · NCT03596450
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, Phase 4, Completed, Novo Nordisk A/S; results first posted 2023-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03596450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03596450
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03596450
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,278 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Semaglutide, Standard of care
- First posted
- 2018-07-23
- Last updated
- 2026-09-30
- Results first posted
- 2023-08-15
Source ClinicalTrials.gov
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | At year 1 | 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 | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 1 | Change in HbA1c from baseline to year 1 is presented in %-point. |
| Secondary | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | At year 2 | 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. |
| Secondary | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 2 | Change in HbA1c from baseline to year 2 is presented in percentage-point. |
| Secondary | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | At year 1 | 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 |
| Secondary | 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) | At year 1 | 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 |
| Secondary | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | At year 1 | 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 |
| Secondary | Change in Body Weight (in Pounds) From Baseline to Year 1 | 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 is presented. |
| Secondary | Percentage Change in Body Weight From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Percentage change in body weight from baseline to year 1 is presented. |
| Secondary | Change in Systolic Blood Pressure (SBP) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change in SBP from baseline to year 1 is presented. |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 registered outcomesOutcomes69
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | At year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage-point of HbA1c | MEAN |
| SECONDARY | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | At year 2 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 2 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage-point of HbA1c | MEAN |
| SECONDARY | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | At year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | At year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | At year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Body Weight (in Pounds) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Pounds (lbs) | MEAN |
| SECONDARY | Percentage Change in Body Weight From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage change in body weight | MEAN |
| SECONDARY | Change in Systolic Blood Pressure (SBP) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Millimeters of mercury (mmHg) | MEAN |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 outcomesResults by group202
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | Semaglutide | Yes | 244 | Participants | |
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | Standard of Care | Yes | 226 | Participants | |
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | Semaglutide | No | 186 | Participants | |
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | Standard of Care | No | 236 | Participants | |
| Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | Semaglutide | -1.46 | Standard Deviation 1.669 | Percentage-point of HbA1c | |
| Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | Standard of Care | -1.14 | Standard Deviation 1.707 | Percentage-point of HbA1c | |
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | Semaglutide | Yes | 209 | Participants | |
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | Standard of Care | Yes | 162 | Participants | |
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | Semaglutide | No | 165 | Participants | |
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | Standard of Care | No | 212 | Participants |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide | 644 | |
| Overall Study | STARTED | Standard of Care | 634 | |
| Overall Study | COMPLETED | Semaglutide | 463 | |
| Overall Study | COMPLETED | Standard of Care | 447 | |
| Overall Study | NOT COMPLETED | Semaglutide | 181 | |
| Overall Study | NOT COMPLETED | Standard of Care | 187 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Coronavirus infection | Infections and infestations | Semaglutide | 5 | 634 | 5 |
| serious | Coronavirus infection | Infections and infestations | Standard of Care | 5 | 621 | 6 |
| serious | Cellulitis | Infections and infestations | Semaglutide | 1 | 634 | 1 |
| serious | Cellulitis | Infections and infestations | Standard of Care | 1 | 621 | 1 |
| serious | Gastroenteritis | Infections and infestations | Semaglutide | 1 | 634 | 2 |
| serious | Gastroenteritis | Infections and infestations | Standard of Care | 0 | 621 | 0 |
| serious | Abdominal sepsis | Infections and infestations | Semaglutide | 1 | 634 | 1 |
| serious | Abdominal sepsis | Infections and infestations | Standard of Care | 0 | 621 | 0 |
| serious | Cystitis | Infections and infestations | Semaglutide | 1 | 634 | 1 |
| serious | Cystitis | Infections and infestations | Standard of Care | 0 | 621 | 0 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide | 9 | 634 |
| Total, all-cause mortality | Standard of Care | 9 | 621 |
| Total, other adverse events | Semaglutide | 0 | 634 |
| Total, other adverse events | Standard of Care | 0 | 621 |
| Total, serious adverse events | Semaglutide | 38 | 634 |
| Total, serious adverse events | Standard of Care | 39 | 621 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Semaglutide vs Standard of Care: deaths from any cause | Trial comparisons |
| Semaglutide vs Standard of Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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