NCT03936660: COORDINATE

A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease

Completed NA Results posted Last updated 21 November 2024

What this trial tests

NA trial testing Intense Education Intervention in Diabetes Mellitus, Type 2 in 1,049 participants. Completed in 30 December 2022.

Timeline

25 July 2019

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,049
Start date	25 July 2019
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	44 locations across United States

Drugs / interventions tested

• Intense Education Intervention

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Duke University

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2 or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications Primary · Up to 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%.

Group	Value	95% CI
Intervention	173
Control	85

Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. Secondary · Up to 12 Months

Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.

Prescribed high-intensity statin

Group	Value	95% CI
Intervention	323
Control	334

Prescribed ACEI or ARB

Group	Value	95% CI
Intervention	372
Control	402

Prescribed SGLT-2i and/or GLP-1RA

Group	Value	95% CI
Intervention	276
Control	209

Prescribed 2 or more groups of recommended medications (composite score >= 2)

Group	Value	95% CI
Intervention	361
Control	326

Prescribed all 3 groups (without metformin monotherapy option)

Group	Value	95% CI
Intervention	142
Control	50

Change in Average LDL-C From Baseline to Last Follow-up Visit. Secondary · Baseline and last follow-up visit (up to 12 months)

Average change in LDL-C values between baseline visit and last follow-up visit.

Baseline

Group	Value	95% CI
Intervention	72.93	± 33.7
Control	75.07	± 30.66

Last follow-up visit

Group	Value	95% CI
Intervention	68.79	± 31.17
Control	70.60	± 32.96

Number of Participants With LDL-C < 70 mg/dL Secondary · Baseline and last follow-up visit (up to 12 months)

Change in number of participants with LDL-C \< 70 mg/dL at baseline visit vs. last follow-up visit.

Baseline

Group	Value	95% CI
Intervention	131
Control	111

Last follow-up visit

Group	Value	95% CI
Intervention	147
Control	126

Change in Average Blood Pressure From Baseline to Last Follow-up Visit. Secondary · Baseline and last follow-up visit (up to 12 months)

Change in systolic and diastolic blood pressure from baseline to last follow-up visit.

Baseline systolic blood pressure

Group	Value	95% CI
Intervention	131.40	± 16.14
Control	129.47	± 16.48

Follow-up systolic blood pressure

Group	Value	95% CI
Intervention	129.09	± 17.36
Control	130.35	± 17.00

Baseline diastolic blood pressure

Group	Value	95% CI
Intervention	74.04	± 10.28
Control	72.35	± 10.90

Follow-up diastolic blood pressure

Group	Value	95% CI
Intervention	72.44	± 10.67
Control	72.01	± 11.28

Number of Participants With sBP < 130 mmHg Secondary · Baseline and last follow-up visit (up to 12 months)

Proportion of participants achieving sBP \< 130 mmHg at baseline vs. last follow-up visit

Baseline

Group	Value	95% CI
Intervention	185
Control	243

Last follow-up visit

Group	Value	95% CI
Intervention	200
Control	252

Number of Participants With dBP < 180 mmHg Secondary · Baseline and last follow-up visit (up to 12 months)

Change in number of participants with dBP \< 180 mmHg from baseline to last follow-up visit

Baseline

Group	Value	95% CI
Intervention	271
Control	348

Last follow-up visit

Group	Value	95% CI
Intervention	267
Control	355

Change in Average HbA1c From Baseline to Last Follow-up Visit. Secondary · Baseline and last follow-up visit (up to 12 months)

Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.

HbA1c at baseline

Group	Value	95% CI
Intervention	7.64	± 1.49
Control	7.50	± 1.40

HbA1c at last follow-up visit

Group	Value	95% CI
Intervention	7.47	± 1.67
Control	7.49	± 1.43

Number of Participants With HbA1c < 7% Secondary · Baseline and last follow-up visit (up to 12 months)

Change in number of participants with HbA1c \< 7% from baseline to last follow-up visit.

Baseline

Group	Value	95% CI
Intervention	181
Control	169

Last follow-up visit

Group	Value	95% CI
Intervention	197
Control	167

Number of Participants Experiencing an Event Within 1 Year Secondary · Up to 12 Months

Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.

Composite (all-cause mortality, MI, stroke, urgent revascularization, decompensated HF)

Group	Value	95% CI
Intervention	23
Control	40

All-cause mortality

Group	Value	95% CI
Intervention	6
Control	16

Hospitalization for myocardial infarction (MI)

Group	Value	95% CI
Intervention	3
Control	3

Hospitalization for stroke

Group	Value	95% CI
Intervention	1
Control	3

Hospitalization for urgent revascularization

Group	Value	95% CI
Intervention	8
Control	7

Hospitalization for decompensated heart failure (HF)

Group	Value	95% CI
Intervention	8
Control	18

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 3/459 (1%)

Deaths: 6/459

Control

Serious: 0/590 (0%)

Deaths: 16/590

Serious adverse events (3 terms)

Reaction	System	Intervention	Control
Urinary tract infection	Infections and infestations	—	—
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	—	—
Acute kidney injury	Infections and infestations	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Intervention	Control
Urinary tract infection	Infections and infestations	—	—
Inflammation	General disorders	—	—
Mental status changes	Infections and infestations	—	—
Hypoglycemia	Infections and infestations	—	—
Fungal infection	Infections and infestations	—	—

Most-reported serious reactions: Urinary tract infection, Hyperglycaemic hyperosmolar nonketotic syndrome, Acute kidney injury.

Data from ClinicalTrials.gov NCT03936660 adverse events section.

Sponsor's own description

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial.
   Pagidipati NJ, Nelson AJ, Kaltenbach LA, Leyva M, et al · · 2023 · cited 67× · PMID 36877177 · DOI 10.1001/jama.2023.2854
2. Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial.
   Tannu M, Kaltenbach L, Pagidipati NJ, McGuire DK, et al · · 2024 · cited 5× · PMID 38934111 · DOI 10.1161/circulationaha.124.068962