Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Semaglutide

Standard of care

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 any medication for the indication of diabetes other than metformin 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semaglutide

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

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

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

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

Change in HbA1c (%-Point) From Baseline to Year 2

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

Number of participants who achieved individualized HbA1c target attained 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

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)

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

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

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

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

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

Percentage Change in Body Weight From Baseline to Year 1

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

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

Change in SBP from baseline to year 1 is presented.

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

Change in DBP from baseline to year 1 is presented.

Time to First Study Drug Discontinuation During 2 Years

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

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

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.

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

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

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.

DTSQc, Total Treatment Satisfaction Score Measured at Year 2

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

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 summary component (PCS) Score and Mental summary component (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.

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

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

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.

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

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

Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).

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

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

Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).

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

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

Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).

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

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

Change from baseline in WPAI-GH activity impairment score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).

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

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

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

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

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

All Cause HCRU: Number of Medications From Baseline to Year 2

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

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

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

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

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

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

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

Diabetes Related HCRU: Number of Diabetes Related Medications From Baseline to Year 2

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

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

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

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

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)

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

Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1.

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

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)

Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1.

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)

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

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)

Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline.

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)

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)

Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline

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)

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

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

Change in SBP From Baseline to Year 2

Change in DBP From Baseline to Year 2

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

Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 1.

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

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)

Number of participants who achieved 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 is presented. Yes: number of participants who achieved 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; No: number of participants who did not achieve 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

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)

Number of participants who achieved 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 is presented. Yes: number of participants who achieved 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; No: number of participants who did not achieve 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.

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)

Number of participants who achieved 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 is presented. Yes: number of participants who achieved 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; No: number of participants who did not achieve 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.

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

Full Information

NCT ID

NCT03596450

First Posted

July 11, 2018

Last Updated

July 21, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03596450

Brief 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

Official 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 Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 13, 2018 (Actual)

Primary Completion Date

June 9, 2022 (Actual)

Study Completion Date

June 9, 2023 (Actual)

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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1278 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.

Intervention Type

Drug

Intervention Name(s)

Standard of care

Intervention Description

Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

At year 1

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Time Frame

At year 2

Title

Change in HbA1c (%-Point) From Baseline to Year 2

Time Frame

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

Title

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

Description

Time Frame

At year 1

Title

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)

Description

Time Frame

At year 1

Title

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

Description

Time Frame

At year 1

Title

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

Description

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

Time Frame

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

Title

Percentage Change in Body Weight From Baseline to Year 1

Description

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

Time Frame

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

Title

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

Description

Change in SBP from baseline to year 1 is presented.

Time Frame

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

Title

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

Description

Change in DBP from baseline to year 1 is presented.

Time Frame

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

Title

Time to First Study Drug Discontinuation During 2 Years

Time Frame

Week 0 to year 2

Title

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

Time Frame

Week 0 to year 2

Title

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

Description

Time Frame

Week 0 to year 1

Title

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

Title

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

Description

Time Frame

At year 1

Title

DTSQc, Total Treatment Satisfaction Score Measured at Year 2

Time Frame

At year 2

Title

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

Description

Time Frame

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

Title

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

Title

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

Description

Time Frame

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

Title

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

Title

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

Description

Time Frame

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

Title

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

Title

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

Description

Time Frame

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

Title

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

Title

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

Description

Time Frame

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

Title

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

Title

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

Description

Time Frame

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

Title

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

Title

All Cause Healthcare Resource Utilization (HCRU): Number of Inpatient Admissions 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

Title

All Cause HCRU: Cumulative Length of Stay for Inpatient Admissions 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

Title

All Cause HCRU: Number of Emergency Room (ER) Encounters 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

Title

All Cause HCRU: Number of Outpatient Encounters 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

Title

All Cause HCRU: Number of Medications 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

Title

All Cause HCRU: Occurrence of 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

Title

All Cause HCRU: Occurrence of 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

Title

All Cause HCRU: Occurrence of 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

Title

Diabetes Related HCRU: Number of Diabetes Related Inpatient Admissions 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

Title

Diabetes Related HCRU: Cumulative Length of Stay for Diabetes Related Inpatient Admissions 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

Title

Diabetes Related HCRU: Number of Diabetes Related ER Encounters 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

Title

Diabetes Related HCRU: Number of Diabetes Related Outpatient Encounters 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

Title

Diabetes Related HCRU: Number of Diabetes Related Medications 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

Title

Diabetes Related HCRU: Occurrence of 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

Title

Diabetes Related HCRU: Occurrence of 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

Title

Diabetes Related HCRU: Occurrence of 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

Title

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

Time Frame

At year 2

Title

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

Title

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

Description

Time Frame

At year 1

Title

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

Time Frame

At year 2

Title

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)

Description

Time Frame

At year 1

Title

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

Title

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

Title

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)

Description

Time Frame

At year 1

Title

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

Title

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)

Description

Time Frame

At year 1

Title

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

Title

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

Time Frame

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

Title

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

Title

Change in 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

Title

Change in 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

Title

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

Description

Time Frame

Week 0 to year 1

Title

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

Title

Description

Time Frame

At year 1

Title

Description

Time Frame

At year 1

Title

Time Frame

At year 2

Title

Time Frame

At year 2

Title

Description

Time Frame

At year 1

Title

Time Frame

At year 2

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Garden Grove

State/Province

California

ZIP/Postal Code

92844

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Milpitas

State/Province

California

ZIP/Postal Code

95035

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mission Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Monterey

State/Province

California

ZIP/Postal Code

93940

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Napa

State/Province

California

ZIP/Postal Code

94558

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pomona

State/Province

California

ZIP/Postal Code

91766-2007

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Jose

State/Province

California

ZIP/Postal Code

95148

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Toluca Lake

State/Province

California

ZIP/Postal Code

91602

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tulare

State/Province

California

ZIP/Postal Code

93274

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Visalia

State/Province

California

ZIP/Postal Code

93291

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06517

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Milford

State/Province

Connecticut

ZIP/Postal Code

06460

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30312

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

04915

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Buford

State/Province

Georgia

ZIP/Postal Code

30519

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

LaGrange

State/Province

Georgia

ZIP/Postal Code

30240

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lilburn

State/Province

Georgia

ZIP/Postal Code

30047

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Locust Grove

State/Province

Georgia

ZIP/Postal Code

30248

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30067

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30075

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sandersville

State/Province

Georgia

ZIP/Postal Code

31082

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Statesboro

State/Province

Georgia

ZIP/Postal Code

30461

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Swainsboro

State/Province

Georgia

ZIP/Postal Code

30401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Waycross

State/Province

Georgia

ZIP/Postal Code

31501

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46016

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Berne

State/Province

Indiana

ZIP/Postal Code

46711

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47725

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46825

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Franklin

State/Province

Indiana

ZIP/Postal Code

46131

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greenfield

State/Province

Indiana

ZIP/Postal Code

46140

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mishawaka

State/Province

Indiana

ZIP/Postal Code

46544

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47304

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Indiana

ZIP/Postal Code

47374

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ashland

State/Province

Kentucky

ZIP/Postal Code

41101

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Covington

State/Province

Kentucky

ZIP/Postal Code

41011

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Paris

State/Province

Kentucky

ZIP/Postal Code

40361

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Kentucky

ZIP/Postal Code

40475

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Belfast

State/Province

Maine

ZIP/Postal Code

04915

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sterling Heights

State/Province

Michigan

ZIP/Postal Code

48310-3503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65803

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12203

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11221

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11023

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Yonkers

State/Province

New York

ZIP/Postal Code

10704

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Blanchester

State/Province

Ohio

ZIP/Postal Code

45107

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Carlisle

State/Province

Ohio

ZIP/Postal Code

45005

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Franklin

State/Province

Ohio

ZIP/Postal Code

45005

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mason

State/Province

Ohio

ZIP/Postal Code

45040

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Harleysville

State/Province

Pennsylvania

ZIP/Postal Code

19438

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lansdale

State/Province

Pennsylvania

ZIP/Postal Code

19446-1002

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

McMurray

State/Province

Pennsylvania

ZIP/Postal Code

15317

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Athens

State/Province

Tennessee

ZIP/Postal Code

37303

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

24201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Humboldt

State/Province

Tennessee

ZIP/Postal Code

38343

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

McMinnville

State/Province

Tennessee

ZIP/Postal Code

37110

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chatham

State/Province

Virginia

ZIP/Postal Code

24531

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Colonial Heights

State/Province

Virginia

ZIP/Postal Code

23834

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Daleville

State/Province

Virginia

ZIP/Postal Code

23083

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22044

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Portsmouth

State/Province

Virginia

ZIP/Postal Code

23701

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Radford

State/Province

Virginia

ZIP/Postal Code

24141

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

South Boston

State/Province

Virginia

ZIP/Postal Code

24592

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Suffolk

State/Province

Virginia

ZIP/Postal Code

23435

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23462

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Warrenton

State/Province

Virginia

ZIP/Postal Code

20186

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Williamsburg

State/Province

Virginia

ZIP/Postal Code

49820

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54303

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53211

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

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

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

We'll reach out to this number within 24 hrs

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

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial