CompletedPhase 4Results posted

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

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 Clinical Trial

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

122

Recruiting sites

Actual enrollment

1,278

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•HbA1c <7.0% achievement

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03596450

Org study IDNN9535-4416

Secondary IDU1111-1207-6474World Health Organization (WHO)

Timeline

Milestones

Study start2018-07-13actual

Study first posted2018-07-23actual

Primary completion2022-06-09actual

Study completion2023-06-09actual

Results first posted2023-08-15actual

Last update posted2024-07-03actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (138)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Patient-reported / QoL

Other clinical outcomes

Cardiovascular outcomes

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Cardiovascular outcomes

9 endpoints

Secondary/registry result

All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

All-cause hospitalization

event count, event

Posted result

Group	Mean · inpatient admissions	95% CI
Semaglutide	0.20	-
Standard of Care	0.25	-

Secondary/registry result

All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

All-cause hospitalization

event count, event

Posted result

Group	Mean · Days	95% CI
Semaglutide	4.7	-
Standard of Care	7.7	-

Secondary/registry result/low confidence

All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, event

Posted result

Group	Mean · ER encounters	95% CI
Semaglutide	0.72	-
Standard of Care	0.29	-

Secondary/registry result

All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

All-cause hospitalization

threshold achievement, event

Posted result

Group	Participants	95% CI
SemaglutideYes	16	-
No	85	-
Standard of CareYes	16	-
No	86	-

Secondary/registry result/low confidence

All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

threshold achievement, event

Posted result

Group	Participants	95% CI
SemaglutideYes	24	-
No	77	-
Standard of CareYes	21	-
No	81	-

Secondary/protocol endpoint/low confidence

All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, event

Secondary/protocol endpoint/low confidence

All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

descriptive

Secondary/protocol endpoint

All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

All-cause hospitalization

threshold achievement, event

Secondary/protocol endpoint/low confidence

All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

threshold achievement, event

Weight & body composition

8 endpoints

Secondary/registry result

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

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · Pounds (lbs)	95% CI
Semaglutide	-9.8	-
Standard of Care	-5.4	-

Secondary/registry result

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

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · Percentage change in body weight	95% CI
Semaglutide	-3.93	-
Standard of Care	-2.02	-

Secondary/registry result

Percentage Change in Body Weight From Baseline to Year 2

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

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · Percentage change in body weight	95% CI
Semaglutide	-4.47	-
Standard of Care	-2.68	-

Secondary/registry result

Change in Body Weight (in Pounds) From Baseline to Year 2

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

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · lbs	95% CI
Semaglutide	-11.1	-
Standard of Care	-6.8	-

Secondary/protocol endpoint

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage Change in Body Weight From Baseline to Year 2

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (in Pounds) From Baseline to Year 2

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

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

50 endpoints

Primary/registry result

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	244	-
No	186	-
Standard of CareYes	226	-
No	236	-

Treatment effect1.3695% CI1.03 - 1.79p0.033Regression, Logistic

Estimate and p-value are based on logistic regression model with logit link function, treatment as categorical effect, and baseline HbA1c as covariate.

Primary/protocol endpoint

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/registry result

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · Percentage-point of HbA1c	95% CI
Semaglutide	-1.46	-
Standard of Care	-1.14	-

Secondary/registry result

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	209	-
No	165	-
Standard of CareYes	162	-
No	212	-

Secondary/registry result

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · Percentage-point of HbA1c	95% CI
Semaglutide	-1.45	-
Standard of Care	-0.98	-

Secondary/registry result

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

Time frame:At year 1

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	216	-
No	214	-
Standard of CareYes	170	-
No	292	-

Secondary/registry result

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

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c, change

Posted result

Group	Participants	95% CI
SemaglutideYes	321	-
No	109	-
Data missing	0	-
Standard of CareYes	301	-
No	160	-
Data missing	1	-

Secondary/registry result

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

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	64	-
No	31	-
Standard of CareYes	53	-
No	45	-

Secondary/registry result

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

Time frame:Week 0 to year 2

time to event, event

Posted result

Group	Mean · Years	95% CI
Semaglutide	1.55	-
Standard of Care	1.43	-

Secondary/registry result

Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No)

Time frame:At year 2

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	182	-
No	192	-
Standard of CareYes	129	-
No	245	-

Secondary/registry result

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 2 (Yes/No)

Time frame:At year 2

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c, change

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	274	-
No	100	-
Standard of CareYes	228	-
No	145	-

Secondary/registry result

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No)

Time frame:At year 1

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	344	-
No	86	-
Standard of CareYes	344	-
No	118	-

Secondary/registry result

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No)

Time frame:At year 2

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	293	-
No	81	-
Standard of CareYes	271	-
No	103	-

Secondary/registry result

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No)

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	229	-
No	201	-
Data missing	0	-
Standard of CareYes	206	-
No	254	-
Data missing	2	-

Secondary/registry result

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No)

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	186	-
No	188	-
Standard of CareYes	135	-
No	238	-

Secondary/registry result

Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No)

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	43	-
No	20	-
Standard of CareYes	29	-
No	23	-

Secondary/registry result

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	41	-
No	90	-
Standard of CareYes	42	-
No	80	-

Secondary/registry result

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	41	-
No	73	-
Standard of CareYes	28	-
No	70	-

Secondary/registry result

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 1

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	77	-
No	54	-
Standard of CareYes	67	-
No	55	-

Secondary/registry result

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 2

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	70	-
No	44	-
Standard of CareYes	53	-
No	45	-

Secondary/registry result

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders, Severe hypoglycemia

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	128	-
No	282	-
Standard of CareYes	68	-
No	358	-

Secondary/registry result

Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)

Time frame:At year 1

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders, Severe hypoglycemia

Posted result

Group	Participants	95% CI
SemaglutideYes	162	-
No	248	-
Standard of CareYes	79	-
No	346	-

Secondary/registry result

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders, Severe hypoglycemia

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	108	-
No	241	-
Standard of CareYes	76	-
No	276	-

Secondary/registry result/low confidence

Time frame:At year 2

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders, Severe hypoglycemia

Posted result

Group	Participants	95% CI
SemaglutideYes	136	-
No	213	-
Standard of CareYes	89	-
No	262	-

Secondary/registry result

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No)

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	199	-
No	211	-
Standard of CareYes	159	-
No	267	-

Secondary/registry result

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Participants	95% CI
SemaglutideYes	159	-
No	190	-
Standard of CareYes	118	-
No	234	-

Secondary/protocol endpoint

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:At year 1

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c, change

LOINC 4548-4

Secondary/protocol endpoint

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

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

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

Time frame:Week 0 to year 2

time to event, event

Secondary/protocol endpoint

Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No)

Time frame:At year 2

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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 2 (Yes/No)

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c, change

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No)

Time frame:At year 1

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No)

Time frame:At year 2

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No)

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No)

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No)

Time frame:At year 2

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 1

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)

Time frame:At year 2

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders, Severe hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Time frame:At year 1

threshold achievement, improvement

Secondary/protocol endpoint

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders, Severe hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Time frame:At year 2

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders, Severe hypoglycemia

Secondary/protocol endpoint

Time frame:At year 1

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Time frame:At year 2

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Mean · Millimeters of mercury (mmHg)	95% CI
Semaglutide	-2.3	-
Standard of Care	-1.8	-

Secondary/registry result

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Mean · mmHg	95% CI
Semaglutide	-1.6	-
Standard of Care	-0.9	-

Secondary/registry result

Change in Systolic Blood Pressure (SBP) From Baseline to Year 2

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Mean · mmHg	95% CI
Semaglutide	-3.0	-
Standard of Care	-2.8	-

Secondary/registry result

Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Mean · mmHg	95% CI
Semaglutide	-1.9	-
Standard of Care	-1.4	-

Secondary/protocol endpoint

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Systolic Blood Pressure (SBP) From Baseline to Year 2

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

28 endpoints

Secondary/registry result

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

Time frame:At year 1

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	13.5	-
Standard of Care	12.8	-

Secondary/registry result/low confidence

DTSQc, Total Treatment Satisfaction Score Measured at Year 2

Time frame:At year 2

descriptive, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	13.2	-
Standard of Care	12.2	-

Secondary/registry result

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	2.8	-
Standard of Care	2.3	-

Secondary/registry result

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	2.6	-
Standard of Care	2.4	-

Secondary/registry result

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	2.4	-
Standard of Care	1.1	-

Secondary/registry result

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	2.4	-
Standard of Care	0.2	-

Secondary/registry result

Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-1.5	-
Standard of Care	0.9	-

Secondary/registry result/low confidence

Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-2.1	-
Standard of Care	0.0	-

Secondary/registry result

Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-5.1	-
Standard of Care	-4.5	-

Secondary/registry result

Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-6.0	-
Standard of Care	-3.8	-

Secondary/registry result

Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-4.8	-
Standard of Care	-4.5	-

Secondary/registry result

Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-6.4	-
Standard of Care	-4.0	-

Secondary/registry result

Change From Baseline in WPAI-GH Activity Impairment Score at Year 1

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-6.7	-
Standard of Care	-3.7	-

Secondary/registry result

Change From Baseline in WPAI-GH Activity Impairment Score at Year 2

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

change from baseline, improvement

Posted result

Group	Mean · Scores on a scale	95% CI
Semaglutide	-5.8	-
Standard of Care	-3.1	-

Secondary/protocol endpoint

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

Time frame:At year 1

change from baseline, improvement

Secondary/protocol endpoint

DTSQc, Total Treatment Satisfaction Score Measured at Year 2

Time frame:At year 2

PGI, change

descriptive, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

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

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in WPAI-GH Activity Impairment Score at Year 1

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in WPAI-GH Activity Impairment Score at Year 2

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

change from baseline, improvement

Safety / tolerability / PK

8 endpoints

Secondary/registry result

Time to First Study Drug Discontinuation During 2 Years

Time frame:Week 0 to year 2

Discontinuation due to AE

time to event, event

Posted result

Group	Mean · Years	95% CI
Semaglutide	1.36	-
Standard of Care	1.54	-

Secondary/registry result

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

Severe hypoglycemia

event count, event

Posted result

Group	Number · Episodes	95% CI
Semaglutide	2	-
Standard of Care	1	-

Secondary/registry result

Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No)

Time frame:Week 0 to year 1

Severe hypoglycemia

threshold achievement, event

Posted result

Group	Participants	95% CI
SemaglutideYes	0	-
No	644	-
Standard of CareYes	0	-
No	634	-

Secondary/registry result

Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No)

Time frame:Week 0 to year 2

Severe hypoglycemia

threshold achievement, event

Posted result

Group	Participants	95% CI
SemaglutideYes	1	-
No	643	-
Standard of CareYes	1	-
No	633	-

Secondary/protocol endpoint

Time to First Study Drug Discontinuation During 2 Years

Time frame:Week 0 to year 2

Discontinuation due to AE

time to event, event

Secondary/protocol endpoint

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

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No)

Time frame:Week 0 to year 1

Severe hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No)

Time frame:Week 0 to year 2

Severe hypoglycemia

threshold achievement, event

Other clinical outcomes

25 endpoints

Secondary/registry result/low confidence

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

descriptive

Posted result

Group	Mean · Percentage of MPR	95% CI
Semaglutide	53.1	-
Standard of Care	55.8	-

Secondary/registry result

All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Posted result

Group	Mean · outpatient encounters	95% CI
Semaglutide	18.7	-
Standard of Care	16.5	-

Secondary/registry result

All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

HCRU medication visits mean

descriptive

Posted result

Group	Mean · medication visits	95% CI
Semaglutide	7.4	-
Standard of Care	2.9	-

Secondary/registry result

All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

threshold achievement, descriptive

Posted result

Group	Participants	95% CI
SemaglutideYes	97	-
No	4	-
Standard of CareYes	101	-
No	1	-

Secondary/registry result

Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, event

Posted result

Group	Mean · inpatient admissions	95% CI
Semaglutide	0.13	-
Standard of Care	0.19	-

Secondary/registry result

Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, event

Posted result

Group	Mean · Days	95% CI
Semaglutide	4.7	-
Standard of Care	8.9	-

Secondary/registry result

Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Posted result

Group	Mean · ER encounters	95% CI
Semaglutide	0.50	-
Standard of Care	0.17	-

Secondary/registry result/low confidence

Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Posted result

Group	Mean · outpatient encounters	95% CI
Semaglutide	9.8	-
Standard of Care	8.1	-

Secondary/registry result/low confidence

Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

change from baseline, descriptive

Posted result

Group	Mean · medication visits	95% CI
Semaglutide	1.4	-
Standard of Care	1.1	-

Secondary/registry result

Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

categorical status, event

Posted result

Group	Participants	95% CI
SemaglutideYes	12	-
No	89	-
Standard of CareYes	12	-
No	90	-

Secondary/registry result

Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

threshold achievement, event

Posted result

Group	Participants	95% CI
SemaglutideYes	18	-
No	83	-
Standard of CareYes	13	-
No	89	-

Secondary/registry result

Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

threshold achievement, event

Posted result

Group	Participants	95% CI
SemaglutideYes	95	-
No	6	-
Standard of CareYes	97	-
No	5	-

Secondary/registry result

Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study

Time frame:Week 0 to year 2

descriptive

Posted result

Group	Mean · Percentage of MPR	95% CI
Semaglutide	57.9	-
Standard of Care	55.7	-

Secondary/protocol endpoint

All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Secondary/protocol endpoint

All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Secondary/protocol endpoint

All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

threshold achievement, event

Secondary/protocol endpoint

Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, event

Secondary/protocol endpoint

Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

descriptive

Secondary/protocol endpoint/low confidence

Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Secondary/protocol endpoint

Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Secondary/protocol endpoint

Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

event count, descriptive

Secondary/protocol endpoint

Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

categorical status, event

Secondary/protocol endpoint

Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

categorical status, event

Secondary/protocol endpoint

Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

categorical status, event

Secondary/protocol endpoint/low confidence

Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study

Time frame:Week 0 to year 2

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

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

descriptive

Secondary/protocol endpoint/low confidence

All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2

Time frame:From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
BMJ open diabetes research & care2025 Oct 15PMID41093600doi:10.1136/bmjdrc-2025-005161via clinicaltrials gov reference derived + pubmed nct search
Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial.
BMJ open diabetes research & care2023 May (month)PMID37137527doi:10.1136/bmjdrc-2022-003206via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.