Phase 4
N=1,278
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
Bottom Line
View on ClinicalTrials.gov: NCT03596450 ↗Enrolled (actual)
1,278
Serious AEs
6.1%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) — 244; 226; 186; 236 Participants — p=0.033
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Semaglutide (Drug); Standard of care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) |
244; 226; 186; 236 | 0.033 sig |
| SECONDARY Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 |
-1.46; -1.14 | — |
| SECONDARY Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) |
209; 162; 165; 212 | — |
| SECONDARY Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2 |
-1.45; -0.98 | — |
| SECONDARY Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) |
216; 170; 214; 292 | — |
| SECONDARY Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) |
321; 301; 109; 160; 0; 1 | — |
| SECONDARY Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) |
64; 53; 31; 45 | — |
| SECONDARY Change in Body Weight (in Pounds) From Baseline to Year 1 |
-9.8; -5.4 | — |
| SECONDARY Percentage Change in Body Weight From Baseline to Year 1 |
-3.93; -2.02 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Year 1 |
-2.3; -1.8 | — |
| SECONDARY Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1 |
-1.6; -0.9 | — |
| SECONDARY Time to First Study Drug Discontinuation During 2 Years |
1.36; 1.54 | — |
| SECONDARY Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years |
1.55; 1.43 | — |
| SECONDARY Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study |
53.1; 55.8 | — |
| SECONDARY Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2 |
2; 1 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1 |
13.5; 12.8 | — |
| SECONDARY DTSQc, Total Treatment Satisfaction Score Measured at Year 2 |
13.2; 12.2 | — |
| SECONDARY Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1 |
2.8; 2.3 | — |
| SECONDARY Change From Baseline in SF-12 v2, PCS-12 Score at Year 2 |
2.6; 2.4 | — |
| SECONDARY Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1 |
2.4; 1.1 | — |
| SECONDARY Change From Baseline in SF-12 v2, MCS-12 Score at Year 2 |
2.4; 0.2 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1 |
-1.5; 0.9 | — |
| SECONDARY Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2 |
-2.1; 0.0 | — |
| SECONDARY Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1 |
-5.1; -4.5 | — |
| SECONDARY Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2 |
-6.0; -3.8 | — |
| SECONDARY Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1 |
-4.8; -4.5 | — |
| SECONDARY Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2 |
-6.4; -4.0 | — |
| SECONDARY Change From Baseline in WPAI-GH Activity Impairment Score at Year 1 |
-6.7; -3.7 | — |
| SECONDARY Change From Baseline in WPAI-GH Activity Impairment Score at Year 2 |
-5.8; -3.1 | — |
| SECONDARY All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2 |
0.20; 0.25 | — |
| SECONDARY All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2 |
4.7; 7.7 | — |
| SECONDARY All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2 |
0.72; 0.29 | — |
| SECONDARY All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2 |
18.7; 16.5 | — |
| SECONDARY All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2 |
7.4; 2.9 | — |
| SECONDARY All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2 |
16; 16; 85; 86 | — |
| SECONDARY All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2 |
24; 21; 77; 81 | — |
| SECONDARY All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2 |
97; 101; 4; 1 | — |
| SECONDARY Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 |
0.13; 0.19 | — |
| SECONDARY Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 |
4.7; 8.9 | — |
| SECONDARY Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2 |
0.50; 0.17 | — |
| SECONDARY Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2 |
9.8; 8.1 | — |
| SECONDARY Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2 |
1.4; 1.1 | — |
| SECONDARY Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2 |
12; 12; 89; 90 | — |
| SECONDARY Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2 |
18; 13; 83; 89 | — |
| SECONDARY Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2 |
95; 97; 6; 5 | — |
| SECONDARY Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No) |
182; 129; 192; 245 | — |
| SECONDARY Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No) |
274; 228; 100; 145 | — |
| SECONDARY Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No) |
344; 344; 86; 118 | — |
| SECONDARY Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No) |
293; 271; 81; 103 | — |
| SECONDARY 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) |
229; 206; 201; 254; 0; 2 | — |
| SECONDARY 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) |
186; 135; 188; 238 | — |
| SECONDARY Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No) |
43; 29; 20; 23 | — |
| SECONDARY 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) |
41; 42; 90; 80 | — |
| SECONDARY 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) |
41; 28; 73; 70 | — |
| SECONDARY 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) |
77; 67; 54; 55 | — |
| SECONDARY 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) |
70; 53; 44; 45 | — |
| SECONDARY Percentage Change in Body Weight From Baseline to Year 2 |
-4.47; -2.68 | — |
| SECONDARY Change in Body Weight (in Pounds) From Baseline to Year 2 |
-11.1; -6.8 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Year 2 |
-3.0; -2.8 | — |
| SECONDARY Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2 |
-1.9; -1.4 | — |
| SECONDARY Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No) |
0; 0; 644; 634 | — |
| SECONDARY Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No) |
1; 1; 643; 633 | — |
| SECONDARY 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) |
128; 68; 282; 358 | — |
| SECONDARY 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) |
162; 79; 248; 346 | — |
| SECONDARY 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 2 (Yes/No) |
108; 76; 241; 276 | — |
| SECONDARY 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 2 (Yes/No) |
136; 89; 213; 262 | — |
| SECONDARY 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) |
199; 159; 211; 267 | — |
| SECONDARY 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 2 (Yes/No) |
159; 118; 190; 234 | — |
| SECONDARY Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study |
57.9; 55.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03596450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.