Trial Outcomes & Findings for A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (NCT NCT03387683)
NCT ID: NCT03387683
Last Updated: 2020-04-27
Results Overview
Patients underwent magnetic resonance imaging (MRI) examination to determine the GLSLV, which is expressed as a percentage. The least square mean (LSM) change from baseline estimates were generated from an analysis of covariance (ANCOVA) model with treatment and baseline value of the endpoint as covariates.
COMPLETED
PHASE4
53 participants
Baseline (Day 1) and end of treatment (Day 42)
2020-04-27
Participant Flow
Fifty three patients with type 2 diabetes and on a stable dose of metformin for at least 6 weeks were enrolled in 1 study center in Sweden and 1 center in Finland. The first patient was enrolled on 28 February 2018 and the last patient's last visit was on 19 March 2019.
Eligible patients were aged between 40 and 75 years, had type 2 diabetes for at least 6 months and had no significant coronary artery disease symptoms. Patients were randomized in a 1:1 ratio, to receive 10 milligram (mg) dapagliflozin or placebo.
Participant milestones
| Measure |
Dapagliflozin 10 mg
Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
|
Placebo
Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Dapagliflozin 10 mg
Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
|
Placebo
Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
|
|---|---|---|
|
Overall Study
In receipt of disallowed medication
|
1
|
0
|
|
Overall Study
Did not receive treatment
|
1
|
0
|
Baseline Characteristics
A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients
Baseline characteristics by cohort
| Measure |
Dapagliflozin 10 mg
n=27 Participants
Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
|
Placebo
n=26 Participants
Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and end of treatment (Day 42)Population: Patients in the MRI evaluable analysis set who, as per clinical judgment, had fasted and abstained from products containing nicotine, caffeine and alcohol for at least 6 hours prior to both of the times when MRI measurements were taken.
Patients underwent magnetic resonance imaging (MRI) examination to determine the GLSLV, which is expressed as a percentage. The least square mean (LSM) change from baseline estimates were generated from an analysis of covariance (ANCOVA) model with treatment and baseline value of the endpoint as covariates.
Outcome measures
| Measure |
Dapagliflozin 10 mg
n=24 Participants
Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
|
Placebo
n=24 Participants
Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Global Longitudinal Strain of the Left Ventricle (GLSLV) at End of Treatment.
|
0.30769 Percentage of GLSLV
Interval -0.35001 to 0.96538
|
-0.00352 Percentage of GLSLV
Interval -0.66121 to 0.65417
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (Day 42)Population: Patients in the CTPET-\[11C\]-acetate evaluable analysis set who, as per clinical judgment, had fasted and abstained from products containing nicotine, caffeine and alcohol for at least 6 hours prior to both of the times when CTPET-\[11C\]-acetate measurements were taken.
A clinical radiologic assessment of acquired computed tomography and positron emission tomography (CTPET)-\[11C\]-acetate images was performed to determine myocardial efficiency. The myocardial efficiency calculation was based on an estimate of energy used for producing LV contractile work (mean arterial pressure (MAP) x stroke volume (SV) x heart rate (HR) / myocardial mass) compared to the total cardiac work (calculated based on the total myocardial oxygen consumption per myocardial mass) and is expressed as a percentage. The LSM change from baseline estimates, were generated from an ANCOVA model with treatment and baseline value of the endpoint as covariates.
Outcome measures
| Measure |
Dapagliflozin 10 mg
n=24 Participants
Patients were randomized to receive an oral dose of 10 mg dapagliflozin, once daily, for 6 weeks.
|
Placebo
n=24 Participants
Patients were randomized to receive an oral dose of placebo (to match 10 mg dapagliflozin), once daily, for 6 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Myocardial Efficiency at End of Treatment.
|
-0.71474 Percentage of Myocardial Efficiency
Interval -3.74654 to 2.31706
|
-2.46443 Percentage of Myocardial Efficiency
Interval -5.49623 to 0.56737
|
Adverse Events
Dapagliflozin 10 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60