Trial Outcomes & Findings for Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes (NCT NCT00736879)
NCT ID: NCT00736879
Last Updated: 2017-04-20
Results Overview
Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) 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. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
COMPLETED
PHASE3
497 participants
Baseline (Day 1), Week 24
2017-04-20
Participant Flow
Study initiated 22 September 2008 and completed 29 December 2009 in drug naive participants with type 2 diabetes mellitus who had inadequate glycemic control, defined as an hemoglobin A1c (HbA1c) greater than, equal to ( ≥) 7.0% and less than equal to (≤) 10.0%, with diet and exercise.
497 enrolled in Qualification Period: 297 completed: 13 withdrew consent, 1 lost to follow up (LTF), 1 pregnancy, 183 no longer met criteria, 2 other; 297 entered Placebo Lead-In Period: 282 completed: 3 withdrew consent, 4 LTF, 5 no longer met criteria, 3 other. 282 treated Double Blind; Follow Up visit: 4 weeks ± 5 days post treatment completion.
Participant milestones
| Measure |
Placebo
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 5 mg
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Double Blind Treatment Period
STARTED
|
68
|
72
|
74
|
68
|
|
Double Blind Treatment Period
COMPLETED
|
65
|
68
|
67
|
63
|
|
Double Blind Treatment Period
NOT COMPLETED
|
3
|
4
|
7
|
5
|
|
Follow up Period - No Drug Treatment
STARTED
|
66
|
70
|
66
|
62
|
|
Follow up Period - No Drug Treatment
COMPLETED
|
65
|
67
|
66
|
62
|
|
Follow up Period - No Drug Treatment
NOT COMPLETED
|
1
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 5 mg
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Double Blind Treatment Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Double Blind Treatment Period
Adverse Event
|
0
|
1
|
1
|
0
|
|
Double Blind Treatment Period
Withdrawal by Subject
|
2
|
1
|
3
|
3
|
|
Double Blind Treatment Period
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Double Blind Treatment Period
Poor non-compliance
|
0
|
0
|
1
|
1
|
|
Double Blind Treatment Period
No longer met criteria
|
0
|
1
|
0
|
0
|
|
Double Blind Treatment Period
non-specified
|
0
|
1
|
0
|
0
|
|
Follow up Period - No Drug Treatment
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Follow up Period - No Drug Treatment
non-specified
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 5 mg
n=68 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 9.04 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 11.51 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 10.57 • n=21 Participants
|
|
Age, Customized
Less than (<) 65 years
|
55 participants
n=5 Participants
|
63 participants
n=7 Participants
|
61 participants
n=5 Participants
|
61 participants
n=4 Participants
|
240 participants
n=21 Participants
|
|
Age, Customized
Greater than, equal to (>=) 65 and < 75 years
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
6 participants
n=4 Participants
|
38 participants
n=21 Participants
|
|
Age, Customized
>= 75 years
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Age, Customized
Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Age, Customized
Female <= 50 years
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
22 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Age, Customized
Female > 50 years
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
29 participants
n=5 Participants
|
14 participants
n=4 Participants
|
86 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
57 participants
n=5 Participants
|
56 participants
n=7 Participants
|
61 participants
n=5 Participants
|
55 participants
n=4 Participants
|
229 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
38 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Hispanic/Latino
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Not Hispanic/Latino
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Not Reported
|
55 participants
n=5 Participants
|
58 participants
n=7 Participants
|
61 participants
n=5 Participants
|
56 participants
n=4 Participants
|
230 participants
n=21 Participants
|
|
Body Mass Index in Kg/m^2
< 25 kg/m^2
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
7 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Body Mass Index in Kg/m^2
>=25 kg/m^2
|
65 participants
n=5 Participants
|
66 participants
n=7 Participants
|
64 participants
n=5 Participants
|
61 participants
n=4 Participants
|
256 participants
n=21 Participants
|
|
Body Mass Index in Kg/m^2
>=27 kg/m^2
|
60 participants
n=5 Participants
|
57 participants
n=7 Participants
|
54 participants
n=5 Participants
|
48 participants
n=4 Participants
|
219 participants
n=21 Participants
|
|
Body Mass Index in Kg/m^2
>=30 kg/m^2
|
41 participants
n=5 Participants
|
48 participants
n=7 Participants
|
45 participants
n=5 Participants
|
37 participants
n=4 Participants
|
171 participants
n=21 Participants
|
|
Hemoglobin A1c (HbA1c) %
|
7.80 Percent of Hemoglobin
STANDARD_DEVIATION 1.117 • n=5 Participants
|
7.80 Percent of Hemoglobin
STANDARD_DEVIATION 0.984 • n=7 Participants
|
8.11 Percent of Hemoglobin
STANDARD_DEVIATION 1.072 • n=5 Participants
|
7.94 Percent of Hemoglobin
STANDARD_DEVIATION 1.029 • n=4 Participants
|
7.92 Percent of Hemoglobin
STANDARD_DEVIATION 1.054 • n=21 Participants
|
|
Waist Circumference
|
105.24 cm
STANDARD_DEVIATION 12.653 • n=5 Participants
|
104.14 cm
STANDARD_DEVIATION 11.642 • n=7 Participants
|
101.48 cm
STANDARD_DEVIATION 12.710 • n=5 Participants
|
103.29 cm
STANDARD_DEVIATION 13.745 • n=4 Participants
|
103.50 cm
STANDARD_DEVIATION 12.703 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Week 24Population: N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.
Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) 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. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=66 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=72 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
|
-0.82 Percent Hemoglobin
Standard Error 0.1217 • Interval -1.06 to -0.58
|
0.02 Percent Hemoglobin
Standard Error 0.1200 • Interval -0.22 to 0.25
|
-0.68 Percent Hemoglobin
Standard Error 0.1166 • Interval -0.91 to -0.45
|
-0.72 Percent Hemoglobin
Standard Error 0.1169 • Interval -0.95 to -0.49
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.
Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) 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. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=67 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
|
-2.69 kg
Standard Error 0.3961
|
-0.96 kg
Standard Error 0.3942
|
-2.69 kg
Standard Error 0.3820
|
-2.64 kg
Standard Error 0.3776
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.
Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. 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.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=67 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants
|
-28.5 mg/dL
Standard Error 4.230
|
4.1 mg/dL
Standard Error 4.200
|
-11.0 mg/dL
Standard Error 4.082
|
-21.6 mg/dL
Standard Error 4.025
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.
Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=58 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=58 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=67 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=58 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants
|
-51.8 mg/dL
Standard Error 6.4973
|
8.81 mg/dL
Standard Error 6.4925
|
-33.3 mg/dL
Standard Error 6.0390
|
-39.3 mg/dL
Standard Error 6.5025
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.
Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (\<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=66 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=72 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants
|
49.1 Adjusted Percentage of participants
|
34.6 Adjusted Percentage of participants
|
53.6 Adjusted Percentage of participants
|
43.4 Adjusted Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.
Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. 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.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=61 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=66 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=70 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=65 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants
|
-3.17 cm
Standard Error 0.5933
|
-1.70 cm
Standard Error 0.5718
|
-2.50 cm
Standard Error 0.5540
|
-2.31 cm
Standard Error 0.5775
|
SECONDARY outcome
Timeframe: Day 1 of Double Blind Period to end of Week 24 Plus 30 daysPopulation: Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.
Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=68 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Serious Adverse Event (SAE)
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Related SAE
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Adverse Event (AE)
|
39 participants
|
41 participants
|
42 participants
|
43 participants
|
|
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Related Adverse Event
|
5 participants
|
8 participants
|
5 participants
|
9 participants
|
|
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Discontinued due to AE
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to last dose plus 4 days in 12 Week Double Blind PeriodPopulation: Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs summarized below were prior to rescue.
Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value \< 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement \< 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose \< 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=68 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Other hypoglycemic episode
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AE Suggestive of Genital Infection
|
2 participants
|
2 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AE Suggestive of UTI
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AE of Renal Impairment (creatinine increased)
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AE of Hypotension
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AE of Fracture
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
AE of Urinary Stones
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Cardiac Disorders AEs
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Vascular Disorders AEs
|
1 participants
|
4 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Hypoglycemia AEs (excluding data after rescue)
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Major hypoglycemic episode
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Minor hypoglycemic episode
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: Participants who took at least 1 dose of double-blind study medication were analyzed. n= number of treated participants with non-missing baseline and Week 24 values.
Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. 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.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=62 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=65 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=68 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=65 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants
Systolic Blood Pressure (n=65, 68, 65, 62)
|
-4.6 mmHg
Standard Error 1.531
|
0.8 mmHg
Standard Error 1.462
|
-3.7 mmHg
Standard Error 1.449
|
-3.1 mmHg
Standard Error 1.603
|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants
Diastolic Blood Pressure (n=65, 68, 65, 62)
|
-1.9 mmHg
Standard Error 1.036
|
0.2 mmHg
Standard Error 0.981
|
-1.1 mmHg
Standard Error 1.040
|
-2.0 mmHg
Standard Error 0.980
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.
Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. 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.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=62 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=65 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=68 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=65 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants
|
-1.4 bpm
Standard Error 1.080
|
-1.3 bpm
Standard Error 1.178
|
-2.0 bpm
Standard Error 0.882
|
-1.6 bpm
Standard Error 0.845
|
SECONDARY outcome
Timeframe: Week 24Population: N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline (BL) and Week 24 (LOCF) values.
12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=68 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
Abnormal BL, Abnormal at Week 24(N=68, 72, 74, 68)
|
16 participants
|
16 participants
|
23 participants
|
14 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
Normal at BL, Normal at Week 24 (N=68, 72, 74, 68)
|
38 participants
|
34 participants
|
38 participants
|
43 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
Abnormal BL, Normal at Week 24(N=68, 72, 74, 68)
|
7 participants
|
10 participants
|
5 participants
|
4 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
Normal BL, Abnormal at Week 24(N=68, 72, 74, 68)
|
1 participants
|
4 participants
|
3 participants
|
4 participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
Reported at BL, Not Reported at Week 24
|
6 participants
|
4 participants
|
3 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24/end of treatment plus 4 daysPopulation: N=Number of participants who received at least 1 dose of study medication and had non-missing laboratory results.
Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (\>) less than (\<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin \<6 (\>18 females or \>20 males) g/dL; hematocrit \<20% ( \>55% females or \>60% males); BUN (\>60 mg/dL) or Urea \>21.4 mmol/L; creatinine (\>=1.5\*preRX, \>=2.5 mg/dL); AST and ALT \>3\*ULN; bilirubin \>1.5\*ULN; ALP \>1.5\*ULN.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=67 Participants
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 Participants
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 1mg
n=72 Participants
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 Participants
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Hematocrit High >55% (N=68, 72, 74, 67)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Hemoglobin High >18 g/dL(N=68, 72, 74, 67)
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Creatinine High >=1.5*PreRX(N=68, 72, 74, 67)
|
4 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
AST 3*ULN (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
ALT 3*ULN (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
ALT 5*ULN (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
AST or ALT >3*ULN (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
AST or ALT >5*ULN (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Total bilirubin >1.5*ULN (N=68, 72, 74, 67)
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Total bilirubin >2*ULN (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
ALP >1.5*ULN (N=68, 72, 74, 67)
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
ALP >3*ULN (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Glucose >350 mg/dL (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Creatinine Kinase > 5X ULN (N=68, 72, 74, 67)
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Calcium <7.5 mg/dL (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Calcium (mg/dL) >=1 vs ULN and >=0.5 vs baseline
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Potassium >= 6 meq/L (N=68, 72, 74, 67)
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Magnesium <1 meq/L (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Sodium <130 meq/L (N=68, 72, 74, 67)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Sodium >150 meq/L (N=68, 72, 74, 67)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Sodium < 120 meq/L
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Dapagliflozin 1mg
Dapagliflozin 2.5 mg
Dapagliflozin 5 mg
Placebo
Serious adverse events
| Measure |
Dapagliflozin 1mg
n=72 participants at risk
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 participants at risk
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 5 mg
n=68 participants at risk
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 participants at risk
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Nervous system disorders
Convulsion
|
1.4%
1/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
1.4%
1/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
1.4%
1/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Tuberculosis
|
1.4%
1/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
Other adverse events
| Measure |
Dapagliflozin 1mg
n=72 participants at risk
1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 2.5 mg
n=74 participants at risk
2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Dapagliflozin 5 mg
n=68 participants at risk
5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
Placebo
n=68 participants at risk
Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.9%
5/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
5.4%
4/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
2.9%
2/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
7.4%
5/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
5.4%
4/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
2.9%
2/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
4.4%
3/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
5/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
1.4%
1/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
2.9%
2/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
4.4%
3/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Nervous system disorders
Dizziness
|
4.2%
3/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
6.8%
5/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
2.9%
2/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
0.00%
0/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
1.5%
1/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
5.9%
4/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.8%
2/72 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
1.4%
1/74 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
1.5%
1/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
5.9%
4/68 • 24 Weeks plus 30 days; Day 1 of double blind treatment to last patient, last visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER