Trial Outcomes & Findings for Dapagliflozin and Cholesterol Metabolism in Type 2 Diabetes (DM2) (NCT NCT03074630)

Results Overview

Before and after 5 weeks of dapagliflozin on rosuvastatin background.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

5 weeks

Results posted on

2020-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Dapagliflozin Dapagliflozin treatment for 5 weeks
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dapagliflozin and Cholesterol Metabolism in Type 2 Diabetes (DM2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapagliflozin n=11 Participants Nine male and 3 postmenopausal female participants were included. One female participant was excluded during the study due to missing data, as we were unable to place a venous catheter during the second hyperinsulinemic clamp, thus we present the analysis for the 11 evaluable participtans.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Netherlands	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Before and after 5 weeks of dapagliflozin on rosuvastatin background.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=11 Participants 5 weeks of dapagliflozin
Change in Plasma LDL Cholesterol	-0.1 mmol/L Interval -0.2 to 0.2

SECONDARY outcome

Timeframe: 12 weeks

Population: 5 weeks of dapagliflozin added to rosuvastatin

Change in plasma HDL cholesterol following dapagliflozin

Outcome measures

Outcome measures
Measure	Dapagliflozin n=11 Participants 5 weeks of dapagliflozin
Change in Plasma HDL Cholesterol	0.08 mmol/L Interval -0.03 to 0.13

SECONDARY outcome

Timeframe: 5 weeks

Population: treated with 10mg dapagliflozin

Change in total cholesterol following dapagliflozin

Outcome measures

Outcome measures
Measure	Dapagliflozin n=11 Participants 5 weeks of dapagliflozin
Change in Total Cholesterol	-0.01 mmol/L Interval -0.42 to 0.29

SECONDARY outcome

Timeframe: 5 weeks

Population: dapagliflozin treatment

Change in plasma Triglycerides following dapagliflozin

Outcome measures

Outcome measures
Measure	Dapagliflozin n=11 Participants 5 weeks of dapagliflozin
Change in Plasma Triglycerides	0.10 mmol/L Interval -0.41 to 0.34

SECONDARY outcome

Timeframe: 5 weeks

Population: 5 weeks of dapagliflozin

Change in plasma FFA following dapagliflozin

Outcome measures

Outcome measures
Measure	Dapagliflozin n=11 Participants 5 weeks of dapagliflozin
Change in Plasma FFA	0.20 mmol/L Interval 0.04 to 0.78

SECONDARY outcome

Timeframe: 5 weeks

Population: These measurements were conditional, and have not been performed due to the absent change in the primary outcome.

Including cholesterol production, cholesterol excretion, cholesterol degradation. Before and after 5 weeks of dapagliflozin on rosuvastatin background.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks

Population: These measurements were conditional, and have not been performed due to the absent change in the primary outcome.

Including cholesterol production, cholesterol excretion, cholesterol degradation. Before and after 5 weeks of dapagliflozin on rosuvastatin background

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks

Before and after 5 weeks of dapagliflozin on rosuvastatin background, measured as glucose disposal during hyperinsulinemic euglycemic clamp

Outcome measures

Outcome measures
Measure	Dapagliflozin n=11 Participants 5 weeks of dapagliflozin
Change in Peripheral Insulin Sensitivity	1.6 umol/kg/min Standard Deviation 10.7

SECONDARY outcome

Timeframe: 5 weeks

Population: This measurement was conditional, and has not been performed due to the absent change in the primary outcome. Liver fat content was not measured.

Before and after 5 weeks of dapagliflozin on rosuvastatin background

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks

Population: Sample collection failed. There were not enough samples to perform a proper analysis. Therefore, the few samples that were collected have not been measured and no data is available.

Before and after 5 weeks of dapagliflozin on rosuvastatin background, different bacterial strains will be quantified in fresh fecal samples.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks

Population: This measurement was conditional, and has not been performed due to the absent change in the primary outcome. Since there was no change in plasma cholesterol, this was no longer interesting and samples were not measured

Before and after 5 weeks of dapagliflozin on rosuvastatin background

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks

Population: Subtracted from glucose disposal rate, not separately analyzed in paper

Before and after 5 weeks of dapagliflozin on rosuvastatin background

Outcome measures

Outcome measures
Measure	Dapagliflozin n=11 Participants 5 weeks of dapagliflozin
Urinary Glucose Excretion	44 mg/min Interval 20.0 to 64.0

SECONDARY outcome

Timeframe: 5 weeks

Population: This measurement was conditional, and has not been performed due to the absent change in the primary outcome.

Before and after 5 weeks of dapagliflozin on rosuvastatin background

Outcome measures

Outcome data not reported

Adverse Events

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adverse Events n=12 participants at risk 5 weeks of dapagliflozin
Renal and urinary disorders genital fungal infection	8.3% 1/12 • Number of events 1 • 5 weeks Patient reported and actively assessed

Additional Information

Erik van Bommel

AmsterdamUMC

Phone: +31 20 4444444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place