Trial Outcomes & Findings for Renoprotective Effects of Dapagliflozin in Type 2 Diabetes (NCT NCT02682563)

NCT ID: NCT02682563

Last Updated: 2020-07-07

Results Overview

Calculated from urinary and plasma inulin concentrations, GFR in ml/min

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 44 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-07-07

Participant Flow

Participant milestones

Measure	Dapagliflozin 10mg Once Daily Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Overall Study STARTED	24	20
Overall Study COMPLETED	24	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renoprotective Effects of Dapagliflozin in Type 2 Diabetes

Baseline characteristics by cohort

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks	Total n=44 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 7 • n=5 Participants	63 years STANDARD_DEVIATION 7 • n=7 Participants	63 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Netherlands	24 participants n=5 Participants	20 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Calculated from urinary and plasma inulin concentrations, GFR in ml/min

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Glomerular Filtration Rate (GFR) in ml/Min	104 ml/min Standard Deviation 17	109 ml/min Standard Deviation 20

PRIMARY outcome

Timeframe: 12 weeks

Calculated from urinary and plasma para-aminohippurate concentrations, ERPF in ml/min

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Effective Renal Plasma Flow (ERPF) in ml/Min	639 ml/min Standard Deviation 141	678 ml/min Standard Deviation 122

SECONDARY outcome

Timeframe: 12 weeks

Calculated fractional excretions with measured GFR (see above) and urinary and plasma concentrations of sodium. Fractional excretion in % of filtered sodium

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Fractional Excretion of Sodium in % of Filtered Sodium	0.74 % of filtered sodium Standard Deviation 0.19	0.66 % of filtered sodium Standard Deviation 0.22

SECONDARY outcome

Timeframe: 12 weeks

Calculated fractional excretions with measured GFR (see above) and urinary and plasma concentrations of potassium. Fractional excretion in % of filtered potassium

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Fractional Excretion of Potassium in % of Filtered Potassium	13.6 % of filtered potassium Standard Deviation 3.3	11.8 % of filtered potassium Standard Deviation 3.4

SECONDARY outcome

Timeframe: 12 weeks

Calculated fractional excretions with measured GFR (see above) and urinary and plasma concentrations of glucose. Fractional excretion in % of filtered glucose

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Fractional Excretion of Glucose in % of Filtered Glucose	31.1 % of filtered glucose Standard Deviation 15.6	0.6 % of filtered glucose Standard Deviation 1

SECONDARY outcome

Timeframe: 12 weeks

Calculated from measured urinary albumin and creatinin concentrations, in mg/mmol

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Urinary Albumin-Creatinine Ratio in mg/mmol	0.88 mg/mmol Interval 0.31 to 1.48	0.54 mg/mmol Interval 0.31 to 1.3

SECONDARY outcome

Timeframe: 12 weeks

NGAL (ng/mmoll) measured in urine as a marker of renal damage

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Neutrophil Gelatinase-associated Lipocalin (NGAL)	3.76 ng/mmol Interval 2.24 to 5.84	3.79 ng/mmol Interval 2.8 to 6.29

SECONDARY outcome

Timeframe: 12 weeks

KIM-1 (ng/mmol) measured in urine as a marker of renal damage

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Kidney Injury Molecule-1 (KIM-1) in ng/mmol	0.25 ng/mmol Interval 0.105 to 0.288	0.265 ng/mmol Interval 0.16 to 0.548

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Measured in kilograms

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Body Weight	93.7 kilograms Standard Deviation 16.9	99.6 kilograms Standard Deviation 18.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Blood pressure will be measured using an automated oscillometric blood pressure device (Dinamap®) in mmHg

Outcome measures

Measure	Dapagliflozin 10mg Once Daily n=24 Participants Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 Participants Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Systolic Blood Pressure	129.2 mmHg Standard Deviation 10.7	131.1 mmHg Standard Deviation 11.8

Adverse Events

Dapagliflozin 10mg Once Daily

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Gliclazide Modified Release 30mg Once Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dapagliflozin 10mg Once Daily n=24 participants at risk Once daily treatment with oral dapagliflozin (forxiga) 10mg for 12 consecutive weeks. Dapagliflozin 10mg QD: Dapagliflozin 10mg once daily for 12 weeks	Gliclazide Modified Release 30mg Once Daily n=20 participants at risk Once daily treatment with oral gliclazide MR 30mg for 12 consecutive weeks. Gliclazide 30mg QD: Gliclazide30mg once daily for 12 weeks
Renal and urinary disorders genital fungal infections	20.8% 5/24 • Number of events 5 • 12 weeks	0.00% 0/20 • 12 weeks

Additional Information

Erik van Bommel

AmsterdamUMC

Phone: +31 20 444 2264

Email: e.vanbommel@amsterdamumc.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place