Trial Outcomes & Findings for Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes (NCT NCT00976495)
NCT ID: NCT00976495
Last Updated: 2017-03-08
Results Overview
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.
COMPLETED
PHASE2
154 participants
From Baseline to Week 12
2017-03-08
Participant Flow
Of 154 participants enrolled, 77 completed a qualification period. Of these 77 participants, 75 were randomized and received treatment. Of these 75 participants, 74 completed double-blind treatment period.
Participant milestones
| Measure |
Placebo
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
26
|
|
Overall Study
COMPLETED
|
25
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=24 Participants
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
n=26 Participants
Tablet, oral, once daily for 12 weeks
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 9.50 • n=99 Participants
|
53.7 Years
STANDARD_DEVIATION 9.38 • n=107 Participants
|
54.8 Years
STANDARD_DEVIATION 9.87 • n=206 Participants
|
55.5 Years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
|
Age, Customized
Younger than 65 years
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Age, Customized
65 - 75 years
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Population: All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF)
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.
Outcome measures
| Measure |
Placebo
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=22 Participants
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
n=26 Participants
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])
|
-2.92 % Change of Baseline GFR
Standard Error 2.0133
|
-10.76 % Change of Baseline GFR
Standard Error 1.9684
|
-3.40 % Change of Baseline GFR
Standard Error 1.9756
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.
Outcome measures
| Measure |
Placebo
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=22 Participants
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
|
-0.88 mmHg
Standard Error 1.6373
|
-3.28 mmHg
Standard Error 1.7674
|
-6.55 mmHg
Standard Error 1.6833
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.
Outcome measures
| Measure |
Placebo
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=22 Participants
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
|
-1.55 mmHg
Standard Error 1.7247
|
-5.93 mmHg
Standard Error 1.8673
|
-6.83 mmHg
Standard Error 1.7671
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.
Outcome measures
| Measure |
Placebo
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=22 Participants
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
n=25 Participants
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
|
-0.61 mmHg
Standard Error 1.9468
|
-0.45 mmHg
Standard Error 2.0822
|
-7.76 mmHg
Standard Error 1.9857
|
Adverse Events
Placebo
Dapagliflozin 10 mg
Hydrochlorothiazide 25 mg
Serious adverse events
| Measure |
Placebo
n=25 participants at risk
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=24 participants at risk
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
n=26 participants at risk
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/26 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Injury, poisoning and procedural complications
INTERVERTEBRAL DISC INJURY
|
0.00%
0/25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/26 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.2%
1/24 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/26 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Other adverse events
| Measure |
Placebo
n=25 participants at risk
Tablet, oral, once daily for 12 weeks
|
Dapagliflozin 10 mg
n=24 participants at risk
Tablet, oral, once daily for 12 weeks
|
Hydrochlorothiazide 25 mg
n=26 participants at risk
Tablet, oral, once daily for 12 weeks
|
|---|---|---|---|
|
Renal and urinary disorders
POLLAKIURIA
|
4.0%
1/25 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
12.5%
3/24 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
3.8%
1/26 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Renal and urinary disorders
NOCTURIA
|
4.0%
1/25 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
8.3%
2/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/26 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
7.7%
2/26 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
7.7%
2/26 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
4.2%
1/24 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
15.4%
4/26 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
|
Metabolism and nutrition disorders
MALAISE
|
0.00%
0/25 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
0.00%
0/24 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
7.7%
2/26 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place