Trial Outcomes & Findings for A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease (NCT NCT03936660)
NCT ID: NCT03936660
Last Updated: 2024-11-21
Results Overview
Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c \< 7%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1049 participants
Primary outcome timeframe
Up to 12 Months
Results posted on
2024-11-21
Participant Flow
Unit of analysis: Sites
Participant milestones
| Measure |
Intervention
Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
Provided with existing clinical care guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
459 25
|
590 24
|
|
Overall Study
COMPLETED
|
457 20
|
588 23
|
|
Overall Study
NOT COMPLETED
|
2 5
|
2 1
|
Reasons for withdrawal
| Measure |
Intervention
Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
Provided with existing clinical care guidelines.
|
|---|---|---|
|
Overall Study
Missing medication data at 6 and 12 months.
|
2
|
2
|
Baseline Characteristics
A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
Intervention
n=459 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=590 Participants
Clinics provided with existing clinical care guidelines.
|
Total
n=1049 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
71 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
315 Participants
n=5 Participants
|
396 Participants
n=7 Participants
|
711 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
391 Participants
n=5 Participants
|
550 Participants
n=7 Participants
|
941 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
79 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
324 Participants
n=5 Participants
|
477 Participants
n=7 Participants
|
801 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Health Insurance
Medicare (alone or with other insurance)
|
282 Participants
n=5 Participants
|
410 Participants
n=7 Participants
|
692 Participants
n=5 Participants
|
|
Health Insurance
Private only
|
114 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Health Insurance
Medicaid only
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Health Insurance
Other insurance only
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Health Insurance
No insurance
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Baseline Composite Medication Score
0 points (not taking any recommended medications)
|
27 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Baseline Composite Medication Score
1 point (taking one recommended medication)
|
157 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Baseline Composite Medication Score
2 points (taking two recommended medications)
|
275 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
582 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 MonthsPopulation: All participants for whom medication data was available at 6 or 12 months.
Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c \< 7%.
Outcome measures
| Measure |
Intervention
n=457 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=588 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications
|
173 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Up to 12 MonthsPopulation: All participants for whom medication data was available at 6 or 12 months.
Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.
Outcome measures
| Measure |
Intervention
n=457 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=588 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.
Prescribed high-intensity statin
|
323 Participants
|
334 Participants
|
|
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.
Prescribed ACEI or ARB
|
372 Participants
|
402 Participants
|
|
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.
Prescribed SGLT-2i and/or GLP-1RA
|
276 Participants
|
209 Participants
|
|
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.
Prescribed 2 or more groups of recommended medications (composite score >= 2)
|
361 Participants
|
326 Participants
|
|
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.
Prescribed all 3 groups (without metformin monotherapy option)
|
142 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Baseline and last follow-up visit (up to 12 months)Population: All participants for whom medication data was available at 6 or 12 months, and who had cholesterol data available at baseline and last follow-up.
Average change in LDL-C values between baseline visit and last follow-up visit.
Outcome measures
| Measure |
Intervention
n=244 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=211 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Change in Average LDL-C From Baseline to Last Follow-up Visit.
Baseline
|
72.93 mg/dL
Standard Error 33.7
|
75.07 mg/dL
Standard Error 30.66
|
|
Change in Average LDL-C From Baseline to Last Follow-up Visit.
Last follow-up visit
|
68.79 mg/dL
Standard Error 31.17
|
70.60 mg/dL
Standard Error 32.96
|
SECONDARY outcome
Timeframe: Baseline and last follow-up visit (up to 12 months)Population: Participants with outcome data available at both baseline and last follow-up visit.
Change in number of participants with LDL-C \< 70 mg/dL at baseline visit vs. last follow-up visit.
Outcome measures
| Measure |
Intervention
n=244 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=213 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Number of Participants With LDL-C < 70 mg/dL
Baseline
|
131 participants
|
111 participants
|
|
Number of Participants With LDL-C < 70 mg/dL
Last follow-up visit
|
147 participants
|
126 participants
|
SECONDARY outcome
Timeframe: Baseline and last follow-up visit (up to 12 months)Population: All participants for whom medication data was available at 6 or 12 months, who had systolic and diastolic blood pressure data at baseline and last follow-up visit.
Change in systolic and diastolic blood pressure from baseline to last follow-up visit.
Outcome measures
| Measure |
Intervention
n=377 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=486 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Change in Average Blood Pressure From Baseline to Last Follow-up Visit.
Follow-up diastolic blood pressure
|
72.44 mmHg
Standard Error 10.67
|
72.01 mmHg
Standard Error 11.28
|
|
Change in Average Blood Pressure From Baseline to Last Follow-up Visit.
Baseline systolic blood pressure
|
131.40 mmHg
Standard Error 16.14
|
129.47 mmHg
Standard Error 16.48
|
|
Change in Average Blood Pressure From Baseline to Last Follow-up Visit.
Follow-up systolic blood pressure
|
129.09 mmHg
Standard Error 17.36
|
130.35 mmHg
Standard Error 17.00
|
|
Change in Average Blood Pressure From Baseline to Last Follow-up Visit.
Baseline diastolic blood pressure
|
74.04 mmHg
Standard Error 10.28
|
72.35 mmHg
Standard Error 10.90
|
SECONDARY outcome
Timeframe: Baseline and last follow-up visit (up to 12 months)Population: Participants with outcome data available at both baseline and last follow-up visits
Proportion of participants achieving sBP \< 130 mmHg at baseline vs. last follow-up visit
Outcome measures
| Measure |
Intervention
n=378 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=492 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Number of Participants With sBP < 130 mmHg
Baseline
|
185 participants
|
243 participants
|
|
Number of Participants With sBP < 130 mmHg
Last follow-up visit
|
200 participants
|
252 participants
|
SECONDARY outcome
Timeframe: Baseline and last follow-up visit (up to 12 months)Population: Participants with outcome data available at both baseline and last follow-up visit
Change in number of participants with dBP \< 180 mmHg from baseline to last follow-up visit
Outcome measures
| Measure |
Intervention
n=378 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=498 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Number of Participants With dBP < 180 mmHg
Baseline
|
271 participants
|
348 participants
|
|
Number of Participants With dBP < 180 mmHg
Last follow-up visit
|
267 participants
|
355 participants
|
SECONDARY outcome
Timeframe: Baseline and last follow-up visit (up to 12 months)Population: All participants for whom medication data was available at 6 or 12 months, and who had HbA1c values available at baseline and last follow-up visit.
Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.
Outcome measures
| Measure |
Intervention
n=265 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=237 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Change in Average HbA1c From Baseline to Last Follow-up Visit.
HbA1c at baseline
|
7.64 HbA1c %
Standard Error 1.49
|
7.50 HbA1c %
Standard Error 1.40
|
|
Change in Average HbA1c From Baseline to Last Follow-up Visit.
HbA1c at last follow-up visit
|
7.47 HbA1c %
Standard Error 1.67
|
7.49 HbA1c %
Standard Error 1.43
|
SECONDARY outcome
Timeframe: Baseline and last follow-up visit (up to 12 months)Population: Participants with outcome data available at both baseline and last follow-up visit
Change in number of participants with HbA1c \< 7% from baseline to last follow-up visit.
Outcome measures
| Measure |
Intervention
n=265 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=239 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Number of Participants With HbA1c < 7%
Baseline
|
181 participants
|
169 participants
|
|
Number of Participants With HbA1c < 7%
Last follow-up visit
|
197 participants
|
167 participants
|
SECONDARY outcome
Timeframe: Up to 12 MonthsPopulation: All participants for whom medication data was available at 6 or 12 months.
Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.
Outcome measures
| Measure |
Intervention
n=457 Participants
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=588 Participants
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Number of Participants Experiencing an Event Within 1 Year
Composite (all-cause mortality, MI, stroke, urgent revascularization, decompensated HF)
|
23 participants
|
40 participants
|
|
Number of Participants Experiencing an Event Within 1 Year
All-cause mortality
|
6 participants
|
16 participants
|
|
Number of Participants Experiencing an Event Within 1 Year
Hospitalization for myocardial infarction (MI)
|
3 participants
|
3 participants
|
|
Number of Participants Experiencing an Event Within 1 Year
Hospitalization for stroke
|
1 participants
|
3 participants
|
|
Number of Participants Experiencing an Event Within 1 Year
Hospitalization for urgent revascularization
|
8 participants
|
7 participants
|
|
Number of Participants Experiencing an Event Within 1 Year
Hospitalization for decompensated heart failure (HF)
|
8 participants
|
18 participants
|
Adverse Events
Intervention
Serious events: 3 serious events
Other events: 4 other events
Deaths: 6 deaths
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Intervention
n=459 participants at risk
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=590 participants at risk
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.22%
1/459 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.00%
0/590 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.22%
1/459 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.00%
0/590 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
|
Infections and infestations
Acute kidney injury
|
0.22%
1/459 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.00%
0/590 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
Other adverse events
| Measure |
Intervention
n=459 participants at risk
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
|
Control
n=590 participants at risk
Clinics provided with existing clinical care guidelines.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.22%
1/459 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.00%
0/590 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
|
General disorders
Inflammation
|
0.00%
0/459 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.17%
1/590 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
|
Infections and infestations
Mental status changes
|
0.22%
1/459 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.00%
0/590 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
|
Infections and infestations
Hypoglycemia
|
0.22%
1/459 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.00%
0/590 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
|
Infections and infestations
Fungal infection
|
0.22%
1/459 • Number of events 1 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
0.00%
0/590 • Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place