Trial Outcomes & Findings for Effect of Ertugliflozin on Cardiac Function in Diabetes (NCT NCT03717194)
NCT ID: NCT03717194
Last Updated: 2024-11-20
Results Overview
Change in LVGLS after 24 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2024-11-20
Participant Flow
Participant milestones
| Measure |
Intervention Group
Ertugliflozin 5 mg once daily
|
Control Group
Placebo once daily
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Intervention Group
Ertugliflozin 5 mg once daily
|
Control Group
Placebo once daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=51 Participants
Ertugliflozin 5 mg once daily
|
Control Group
n=51 Participants
Placebo once daily
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 9.9 • n=51 Participants
|
65.3 years
STANDARD_DEVIATION 8.4 • n=51 Participants
|
63.9 years
STANDARD_DEVIATION 9.2 • n=102 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=51 Participants
|
22 Participants
n=51 Participants
|
39 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=51 Participants
|
29 Participants
n=51 Participants
|
63 Participants
n=102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index
|
26.3 kg/m2
STANDARD_DEVIATION 2.9 • n=51 Participants
|
26.4 kg/m2
STANDARD_DEVIATION 3.6 • n=51 Participants
|
26.4 kg/m2
STANDARD_DEVIATION 2.9 • n=102 Participants
|
|
Glycated hemoglobin
|
8.3 %
STANDARD_DEVIATION 1.0 • n=51 Participants
|
8.4 %
STANDARD_DEVIATION 1.1 • n=51 Participants
|
8.4 %
STANDARD_DEVIATION 1.1 • n=102 Participants
|
|
Estimated glomerular filtration rate
|
90.1 mL/min/1.73 m2
STANDARD_DEVIATION 17.6 • n=51 Participants
|
86.9 mL/min/1.73 m2
STANDARD_DEVIATION 16.8 • n=51 Participants
|
88.5 mL/min/1.73 m2
STANDARD_DEVIATION 17.3 • n=102 Participants
|
|
Hypertension
|
35 participants
n=51 Participants
|
35 participants
n=51 Participants
|
70 participants
n=102 Participants
|
|
Dyslipidemia
|
48 participants
n=51 Participants
|
41 participants
n=51 Participants
|
89 participants
n=102 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Change in LVGLS after 24 weeks of treatment
Outcome measures
| Measure |
Ertugliflozin Group
n=51 Participants
Ertugliflozin 5 mg in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
Control Group
n=51 Participants
Placebo in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
|---|---|---|
|
Left Ventricular Global Longitudinal Strain (LVGLS)
|
16.6 % of LVGLS
Standard Deviation 2.8
|
16.4 % of LVGLS
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, Week 24Change in LVMI after 24 weeks of treatment
Outcome measures
| Measure |
Ertugliflozin Group
n=51 Participants
Ertugliflozin 5 mg in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
Control Group
n=51 Participants
Placebo in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
|---|---|---|
|
Left Ventricular Mass Index (LVMI)
|
92.6 g/m2
Standard Deviation 22.7
|
99.1 g/m2
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: Baseline, Week 24Change in LVEF after 24 weeks of treatment
Outcome measures
| Measure |
Ertugliflozin Group
n=51 Participants
Ertugliflozin 5 mg in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
Control Group
n=51 Participants
Placebo in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
|
61.3 % of LVEF
Standard Deviation 7.0
|
61.5 % of LVEF
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline, Week 24Change in E/e' ratio after 24 weeks of treatment
Outcome measures
| Measure |
Ertugliflozin Group
n=51 Participants
Ertugliflozin 5 mg in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
Control Group
n=51 Participants
Placebo in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
|---|---|---|
|
E/e' Ratio
|
10.6 ratio
Standard Deviation 3.1
|
10.4 ratio
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 24Change in LVVI after 24 weeks of treatment
Outcome measures
| Measure |
Ertugliflozin Group
n=51 Participants
Ertugliflozin 5 mg in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
Control Group
n=51 Participants
Placebo in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
|---|---|---|
|
Left Atrium Ventricular Index (LAVI)
|
35.5 mL/m2
Standard Deviation 11.3
|
35.3 mL/m2
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline, Week 24Change in LVEDV after 24 weeks of treatment
Outcome measures
| Measure |
Ertugliflozin Group
n=51 Participants
Ertugliflozin 5 mg in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
Control Group
n=51 Participants
Placebo in addition to their preexisting oral antidiabetic medications, except for other SGLT2 inhibitors, or insulin
|
|---|---|---|
|
Left Ventricular End-diastolic Volume (LVEDV)
|
82.2 mL
Standard Deviation 24.7
|
75.0 mL
Standard Deviation 17.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24Outcome measures
Outcome data not reported
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=51 participants at risk
Ertugliflozin 5 mg once daily
|
Control Group
n=51 participants at risk
Placebo once daily
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
5.9%
3/51 • Over a 24-week period
|
2.0%
1/51 • Over a 24-week period
|
|
Infections and infestations
Genital infection
|
3.9%
2/51 • Over a 24-week period
|
2.0%
1/51 • Over a 24-week period
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • Over a 24-week period
|
5.9%
3/51 • Over a 24-week period
|
|
Endocrine disorders
Dehydration
|
2.0%
1/51 • Over a 24-week period
|
0.00%
0/51 • Over a 24-week period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place