Trial Outcomes & Findings for Comparison of Type 2 Diabetes Pharmacotherapy Regimens (NCT NCT05073692)
NCT ID: NCT05073692
Last Updated: 2025-11-21
Results Overview
3-point MACE is defined as a single outcome measure, which is a composite measure of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular disease death.
Recruitment status
COMPLETED
Target enrollment
241981 participants
Primary outcome timeframe
2.5 years
Results posted on
2025-11-21
Participant Flow
Participant milestones
| Measure |
SU Initiators
Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042.
|
DPP4 Initiators
Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862.
|
SGLT2i Initiators
Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858.
|
GLP-1RA Initiators
Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
212042
|
5862
|
14858
|
9219
|
|
Overall Study
COMPLETED
|
169348
|
4402
|
13681
|
7863
|
|
Overall Study
NOT COMPLETED
|
42694
|
1460
|
1177
|
1356
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Type 2 Diabetes Pharmacotherapy Regimens
Baseline characteristics by cohort
| Measure |
SU Initiators
n=212 Participants
Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042.
|
DPP4 Initiators
n=5 Participants
Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862.
|
SGLT2i Initiators
n=14 Participants
Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858.
|
GLP-1RA Initiators
n=9 Participants
Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219.
|
Total
n=241981 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.91 years
STANDARD_DEVIATION 12.91 • n=68 Participants
|
61.69 years
STANDARD_DEVIATION 12.88 • n=76 Participants
|
60.51 years
STANDARD_DEVIATION 11.95 • n=48 Participants
|
55.95 years
STANDARD_DEVIATION 12.34 • n=33 Participants
|
57.21 years
STANDARD_DEVIATION 12.88 • n=225 Participants
|
|
Sex: Female, Male
Female
|
95,560 Participants
n=68 Participants
|
3,123 Participants
n=76 Participants
|
6,537 Participants
n=48 Participants
|
5,319 Participants
n=33 Participants
|
110539 Participants
n=225 Participants
|
|
Sex: Female, Male
Male
|
116,482 Participants
n=68 Participants
|
2,739 Participants
n=76 Participants
|
8,321 Participants
n=48 Participants
|
3,900 Participants
n=33 Participants
|
131442 Participants
n=225 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
78,965 Participants
n=68 Participants
|
1,098 Participants
n=76 Participants
|
3,501 Participants
n=48 Participants
|
1,943 Participants
n=33 Participants
|
85507 Participants
n=225 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133,077 Participants
n=68 Participants
|
4,764 Participants
n=76 Participants
|
11,357 Participants
n=48 Participants
|
7,276 Participants
n=33 Participants
|
156474 Participants
n=225 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=225 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1,505 Participants
n=68 Participants
|
26 Participants
n=76 Participants
|
92 Participants
n=48 Participants
|
48 Participants
n=33 Participants
|
1671 Participants
n=225 Participants
|
|
Race (NIH/OMB)
Asian
|
33,756 Participants
n=68 Participants
|
735 Participants
n=76 Participants
|
2,690 Participants
n=48 Participants
|
731 Participants
n=33 Participants
|
37912 Participants
n=225 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3,303 Participants
n=68 Participants
|
61 Participants
n=76 Participants
|
371 Participants
n=48 Participants
|
143 Participants
n=33 Participants
|
3878 Participants
n=225 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20,977 Participants
n=68 Participants
|
669 Participants
n=76 Participants
|
1,483 Participants
n=48 Participants
|
1,343 Participants
n=33 Participants
|
24472 Participants
n=225 Participants
|
|
Race (NIH/OMB)
White
|
103,428 Participants
n=68 Participants
|
3,689 Participants
n=76 Participants
|
7,666 Participants
n=48 Participants
|
5,609 Participants
n=33 Participants
|
120392 Participants
n=225 Participants
|
|
Race (NIH/OMB)
More than one race
|
5,740 Participants
n=68 Participants
|
186 Participants
n=76 Participants
|
662 Participants
n=48 Participants
|
523 Participants
n=33 Participants
|
7111 Participants
n=225 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
43,333 Participants
n=68 Participants
|
496 Participants
n=76 Participants
|
1,894 Participants
n=48 Participants
|
822 Participants
n=33 Participants
|
46545 Participants
n=225 Participants
|
PRIMARY outcome
Timeframe: 2.5 years3-point MACE is defined as a single outcome measure, which is a composite measure of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular disease death.
Outcome measures
| Measure |
SU Initiators
n=212 Participants
Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042.
|
DPP4 Initiators
n=5 Participants
Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862.
|
SGLT2i Initiators
n=14 Participants
Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858.
|
GLP-1RA Initiators
n=9 Participants
Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219.
|
|---|---|---|---|---|
|
Incidence of 3-point Major Adverse Cardiovascular Events (MACE)
|
11,348 Participants
|
393 Participants
|
424 Participants
|
296 Participants
|
Adverse Events
SU Initiators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4867 deaths
DPP4 Initiators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 235 deaths
SGLT2i Initiators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 117 deaths
GLP-1RA Initiators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 109 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Romain Neugebauer
Kaiser Permanente Division of Research
Phone: 510-891-3234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place