Trial Outcomes & Findings for Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration (NCT NCT02911792)
NCT ID: NCT02911792
Last Updated: 2023-11-30
Results Overview
Change from baseline in GFR after treatment from baseline to 4 months
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
4 months
Results posted on
2023-11-30
Participant Flow
Type 2 Diabetes patients recently diagnosed either drug naive or or metformin in good general health with eGFR either above 125 or below 124 ml/min per 1.73 m2 were recruited
eGFR Above 125 ml/min per 1.73m2 included in the HYPERFILTRATION GROUPS. eGFR Below 124 ml/min per 1.73m2 included in the NORMOFILTRATION GROUPS
Participant milestones
| Measure |
Dapagliflozin/Hyperfiltration
Subjects with eGFR equal or above 125 ml/min/1.73m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin?Hyperfiltration
Subjects eGFR equal or above 125 ml/min/1.73m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
Dapagliflozin/Normofiltration
Subjects eGFR equal or below 124 ml/min/1.73m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Normofiltration
Subjects with eGFR equal or below 125 ml/min/1.73m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Dapagliflozin/Hyperfiltration
Subjects with eGFR equal or above 125 ml/min/1.73m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin?Hyperfiltration
Subjects eGFR equal or above 125 ml/min/1.73m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
Dapagliflozin/Normofiltration
Subjects eGFR equal or below 124 ml/min/1.73m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Normofiltration
Subjects with eGFR equal or below 125 ml/min/1.73m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
3
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dapagliflozin/Hyperfiltration
n=15 Participants
Subjects with eGFR above 125 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Hyperfiltration
n=15 Participants
Subjects with GFR above 125 ml/min per 1.73m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
Dapagliflozin/Normofiltration
n=15 Participants
Subjects with eGFR below 124 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Normofiltration
n=15 Participants
Subjects with GFR below 124 ml/min per 1.73m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
60 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 5 • n=15 Participants
|
55 years
STANDARD_DEVIATION 5 • n=15 Participants
|
51 years
STANDARD_DEVIATION 6 • n=15 Participants
|
54 years
STANDARD_DEVIATION 4 • n=15 Participants
|
52 years
STANDARD_DEVIATION 5 • n=60 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
36 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
24 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Type 2 diabetes in good general health with eGFR above or below125 ml/min/1.73m\^2 either drug naïve or on metformin.
Change from baseline in GFR after treatment from baseline to 4 months
Outcome measures
| Measure |
Dapagliflozin/Hyperfiltration
n=15 Participants
Subjects with eGFR above 125 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Hyperfiltration
n=15 Participants
Subjects with eGFR above 125 ml/min per 1.73m2 drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
Dapagliflozin/Normofiltration
n=15 Participants
Subjects with eGFR below 124 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Normofiltration
n=15 Participants
Subjects with eGFR below 124 ml/min per 1.73m2 drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
|---|---|---|---|---|
|
GFR (Glomerular Filtration Rate) Change After Treatment
|
22 ml/min/1.73m^2
Standard Error 6
|
1 ml/min/1.73m^2
Standard Error 5
|
8 ml/min/1.73m^2
Standard Error 3
|
0 ml/min/1.73m^2
Standard Error 4
|
Adverse Events
Dapagliflozin/Hyperfiltration
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Metformin/Hyperfiltration
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dapagliflozin/Normofiltration
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Metformin/Normofiltration
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapagliflozin/Hyperfiltration
n=15 participants at risk
Subjects with eGFR above 125 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Hyperfiltration
n=15 participants at risk
Subjects with eGFR above 125 ml/min per 1.73 m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
Dapagliflozin/Normofiltration
n=15 participants at risk
Subjects with eGFR below 124 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization we will add Dapagliflozin to current metformin.
Dapagliflozin: SGLT2 inhibitor
Metformin: Oral diabetes medicine that helps control blood sugar levels.
|
Metformin/Normofiltration
n=15 participants at risk
ubjects with eGFR below 124 ml/min per 1.73 m2 who are drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).
Metformin: Oral diabetes medicine that helps control blood sugar levels.
Glipizide 5 MG: Oral diabetes medicine that helps control blood sugar levels.
|
|---|---|---|---|---|
|
Infections and infestations
Genital Mycotic Infection
|
13.3%
2/15 • Number of events 2 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
0.00%
0/15 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
26.7%
4/15 • Number of events 4 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
0.00%
0/15 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
|
Endocrine disorders
Mild Hypoglycemia
|
0.00%
0/15 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
20.0%
3/15 • Number of events 3 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
0.00%
0/15 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
13.3%
2/15 • Number of events 2 • All adverse events were recorded during the entire 4 months period of the study
Adverse events collection relied on volunteers reports and physical examination with periodic laboratory analysis, as necessary
|
Additional Information
Ralph DeFronzo, MD - Chief Diabetes Division - Medicine
University of Texas Health Science Center at San Antonio
Phone: 210 567 6706
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place