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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

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ClinicalTrials.gov Identifier: NCT03596450
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Standard of care Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 19, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide
Participants will receive semaglutide 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.
Drug: Semaglutide
Participants will be prescribed commercially available semaglutide and will be instructed to initiate treatment with semaglutide 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.

Active Comparator: Standard of care
Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
Drug: Standard of care
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 Measures :
  1. Hemoglobin A1c (HbA1c) less than 7.0% (53 mmol/mol) (yes/no) [ Time Frame: At year 1 ]
    Number of subjects


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline (less than 90 days prior to randomization at week 0), year 1 ]
    Measured in %-points

  2. HbA1c less than 7.0% (53 mmol/mol) (yes/no) [ Time Frame: At year 2 ]
    Number of subjects

  3. Change in HbA1c [ Time Frame: Baseline (less than 90 days prior to randomization at week 0), year 2 ]
    Measured in %-points

  4. Individualized HbA1c target attained (yes/no) [ Time Frame: At year 1 ]
    Number of subjects. Study physicians will set and document an individualized HbA1c target for patients prior to randomization based on their clinical judgement and knowledge of the patient.

  5. HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline (yes/no) [ Time Frame: At year 1 ]
    Number of subjects

  6. HbA1c target attainment per Healthcare Effectiveness Data and Information Set (HEDIS) criteria (yes/No) [ Time Frame: At year 1 ]
    Number of subjects. HEDIS criteria: HbA1c less than 8.0% if age more than or equal to 65 years or with defined comorbidities, otherwise less than 7.0%

  7. Change in body weight [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    Measured in lb

  8. Change in body weight [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    Measured in %

  9. Change in systolic blood pressure (SBP) [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    Measured in mm Hg

  10. Change in diastolic blood pressure (DBP) [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    Measured in mm Hg

  11. Time to first study drug discontinuation [ Time Frame: Week 0 - year 2 ]
    Measured in days

  12. Time to first treatment intensification (add-on) or change (switch) [ Time Frame: After randomization (week 0) during 2 years ]
    Measured in day

  13. Study drug medication adherence for the first year of the study, as measured by medication possession ratio (MPR) [ Time Frame: Week 0 - year 1 ]
    Measured in %

  14. Number of hypoglycemic episodes leading to an inpatient admission or emergency room (ER) encounter [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of episodes

  15. Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Total treatment satisfaction score [ Time Frame: At year 1 ]
    The DTSQc provides a measure of how satisfied patients are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.

  16. DTSQc, Total treatment satisfaction score [ Time Frame: At year 2 ]
    The DTSQc provides a measure of how satisfied patients are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.

  17. Change from baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical summary component (PCS-12) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items will be 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.

  18. Change from baseline in SF-12 v2, PCS-12 score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 ]
    The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items will be 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.

  19. Change from baseline in SF-12 v2, Mental summary component (MCS-12) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items will be scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.

  20. Change from baseline in SF-12 v2, MCS-12 score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 ]
    The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items will be 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.

  21. Change from baseline in Work Productivity and Activity Impairment, General Health questionnaire (WPAI-GH) Absenteeism (work time missed) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    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 percentages, 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).

  22. Change from baseline in WPAI-GH Absenteeism (work time missed) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 ]
    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 percentages, 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).

  23. Change from baseline in WPAI-GH Presenteeism (impairment at work / reduced on-the-job effectiveness) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    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 percentages, 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).

  24. Change from baseline in WPAI-GH Presenteeism (impairment at work / reduced on-the-job effectiveness) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 ]
    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 percentages, 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).

  25. Change from baseline in WPAI-GH Work productivity loss (overall work impairment / absenteeism plus presenteeism) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    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 percentages, 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).

  26. Change from baseline in WPAI-GH Work productivity loss (overall work impairment / absenteeism plus presenteeism) score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 ]
    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 percentages, 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).

  27. Change from baseline in WPAI-GH Activity Impairment score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 ]
    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 percentages, 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).

  28. Change from baseline in WPAI-GH Activity Impairment score [ Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 ]
    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 percentages, 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).

  29. All cause healthcare resource utilization (HCRU): Number of inpatient admissions [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of admissions

  30. All cause HCRU: Cumulative length of stay for inpatient admissions [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Measured in days

  31. All cause HCRU: Number of ER encounters [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of ER encounters

  32. All cause HCRU: Number of outpatient encounters [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of outpatient encounters

  33. All cause HCRU: Number of medications [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of medications

  34. All cause HCRU: Occurrence of inpatient admission (yes/no) [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of participants

  35. All cause HCRU: Occurrence of ER encounter (yes/no) [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of participants

  36. All cause HCRU: Occurrence of outpatient encounter (yes/no) [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of participants

  37. Diabetes related HCRU: Number of diabetes related inpatient admissions [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of admissions

  38. Diabetes related HCRU: Cumulative length of stay for diabetes related inpatient admissions [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of days

  39. Diabetes related HCRU: Number of diabetes related ER encounters [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of ER encounters

  40. Diabetes related HCRU: Number of diabetes related outpatient encounters [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of outpatient encounters

  41. Diabetes related HCRU: Number of diabetes related medications [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of diabetes related medications

  42. Diabetes related HCRU: Occurrence of diabetes related inpatient admission (yes/no) [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of participants

  43. Diabetes related HCRU: Occurrence of diabetes related ER encounter (yes/no) [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of participants

  44. Diabetes related HCRU: Occurrence of diabetes related outpatient encounter (yes/no) [ Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 ]
    Number of participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 greater than or equal to 18 years at the time of signing informed consent - Type 2 diabetes mellitus diagnosis - Treatment with metformin as antidiabetic monotherapy - Current member of an Anthem affiliated commercial health plan - Recorded Haemoglobin A1c 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596450


Contacts
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
United States, California
Novo Nordisk Investigational Site Not yet recruiting
Monterey, California, United States, 93940
Novo Nordisk Investigational Site Not yet recruiting
San Jose, California, United States, 95148
Novo Nordisk Investigational Site Not yet recruiting
Tulare, California, United States, 93274
United States, Connecticut
Novo Nordisk Investigational Site Not yet recruiting
Milford, Connecticut, United States, 06460
United States, Georgia
Novo Nordisk Investigational Site Not yet recruiting
Lilburn, Georgia, United States, 30047
Novo Nordisk Investigational Site Not yet recruiting
Sandersville, Georgia, United States, 31082
Novo Nordisk Investigational Site Not yet recruiting
Savannah, Georgia, United States, 31406
Novo Nordisk Investigational Site Recruiting
Statesboro, Georgia, United States, 30461
Novo Nordisk Investigational Site Not yet recruiting
Stockbridge, Georgia, United States, 30281
Novo Nordisk Investigational Site Not yet recruiting
Swainsboro, Georgia, United States, 30401
United States, Kentucky
Novo Nordisk Investigational Site Not yet recruiting
Covington, Kentucky, United States, 41011
Novo Nordisk Investigational Site Not yet recruiting
Owensboro, Kentucky, United States, 42303
United States, Virginia
Novo Nordisk Investigational Site Not yet recruiting
Chatham, Virginia, United States, 24531
Novo Nordisk Investigational Site Not yet recruiting
Colonial Heights, Virginia, United States, 23834
Novo Nordisk Investigational Site Not yet recruiting
Falls Church, Virginia, United States, 22044
Novo Nordisk Investigational Site Not yet recruiting
Lynchburg, Virginia, United States, 24501
Novo Nordisk Investigational Site Not yet recruiting
Warrenton, Virginia, United States, 20186
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03596450     History of Changes
Other Study ID Numbers: NN9535-4416
U1111-1207-6474 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs