Trial Outcomes & Findings for Evaluation of Dapagliflozin Taken Twice-daily (NCT NCT01217892)
NCT ID: NCT01217892
Last Updated: 2014-10-27
Results Overview
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2014-10-27
Participant Flow
First participant enrolled: 5 November 2010. Last participant last visit for the 16-week period: 25 August 2011. 520 participants were enrolled, and 400 were randomized in 53 study centers in Europe and South Africa. Subjects with T2DM who showed inadequate glycemic control on metformin therapy alone.
During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Subjects eligible for the study were stratified according to their baseline HbA1c.
Participant milestones
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
99
|
101
|
|
Overall Study
COMPLETED
|
93
|
94
|
90
|
93
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
9
|
8
|
Reasons for withdrawal
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
|
Overall Study
Lab value
|
1
|
0
|
1
|
0
|
|
Overall Study
Subject no longer meets study criteria
|
5
|
2
|
4
|
8
|
|
Overall Study
Incorrect enrollment
|
0
|
1
|
1
|
0
|
|
Overall Study
Poor/Non-Compliance
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of Dapagliflozin Taken Twice-daily
Baseline characteristics by cohort
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=100 Participants
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=99 Participants
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=99 Participants
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=101 Participants
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 9.01 • n=99 Participants
|
55.3 Years
STANDARD_DEVIATION 9.34 • n=107 Participants
|
58.5 Years
STANDARD_DEVIATION 9.78 • n=206 Participants
|
58.5 Years
STANDARD_DEVIATION 9.40 • n=7 Participants
|
57.7 Years
STANDARD_DEVIATION 9.45 • n=31 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
220 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
179 Participants
n=31 Participants
|
|
HbA1c
|
7.77 Percent [%]
STANDARD_DEVIATION 0.747 • n=99 Participants
|
7.78 Percent [%]
STANDARD_DEVIATION 0.762 • n=107 Participants
|
7.71 Percent [%]
STANDARD_DEVIATION 0.709 • n=206 Participants
|
7.94 Percent [%]
STANDARD_DEVIATION 0.848 • n=7 Participants
|
7.80 Percent [%]
STANDARD_DEVIATION 0.770 • n=31 Participants
|
|
Fasting Plasma Glucose (FPG)
|
153.3 mg/dL
STANDARD_DEVIATION 33.27 • n=99 Participants
|
155.3 mg/dL
STANDARD_DEVIATION 31.92 • n=107 Participants
|
155.3 mg/dL
STANDARD_DEVIATION 36.26 • n=206 Participants
|
157.8 mg/dL
STANDARD_DEVIATION 35.93 • n=7 Participants
|
155.4 mg/dL
STANDARD_DEVIATION 34.30 • n=31 Participants
|
|
Body weight
|
92.49 kg
STANDARD_DEVIATION 18.632 • n=99 Participants
|
93.62 kg
STANDARD_DEVIATION 16.641 • n=107 Participants
|
90.58 kg
STANDARD_DEVIATION 15.929 • n=206 Participants
|
88.82 kg
STANDARD_DEVIATION 15.327 • n=7 Participants
|
91.37 kg
STANDARD_DEVIATION 16.716 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Outcome measures
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=99 Participants
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=97 Participants
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=98 Participants
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=100 Participants
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Adjusted Mean Change in HbA1c Levels
|
-0.52 Percent
Standard Error 0.0594 • Interval -0.63 to -0.4
|
-0.65 Percent
Standard Error 0.0600 • Interval -0.77 to -0.53
|
-0.59 Percent
Standard Error 0.0598 • Interval -0.7 to -0.47
|
-0.30 Percent
Standard Error 0.0593 • Interval -0.42 to -0.18
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values
To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Outcome measures
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=100 Participants
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=99 Participants
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=99 Participants
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=101 Participants
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Adjusted Percent Change in Body Weight
|
-2.84 Percent
Standard Error 0.3099
|
-3.20 Percent
Standard Error 0.3125
|
-2.76 Percent
Standard Error 0.3086
|
-1.04 Percent
Standard Error 0.3105
|
SECONDARY outcome
Timeframe: Baseline to Week 1Population: Full Analysis Set, participants with non-missing baseline and Week 1 values
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.
Outcome measures
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=99 Participants
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=99 Participants
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=98 Participants
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=101 Participants
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1
|
-13.7 mg/dL
Standard Error 2.657
|
-14.7 mg/dL
Standard Error 2.672
|
-15.5 mg/dL
Standard Error 2.634
|
2.0 mg/dL
Standard Error 2.584
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Outcome measures
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=100 Participants
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=99 Participants
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=98 Participants
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=101 Participants
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
|
-20.8 mg/dL
Standard Error 2.738
|
-25.6 mg/dL
Standard Error 2.759
|
-20.4 mg/dL
Standard Error 2.720
|
-10.4 mg/dL
Standard Error 2.669
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values
To compare the adjusted proportions controlling for baseline HbA1c \[acc. to Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu\] of participants with HbA1c \<7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.
Outcome measures
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=89 Participants
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=90 Participants
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=81 Participants
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=87 Participants
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.
|
33.6 Percentage of participants
Interval 24.6 to 42.5
|
38.2 Percentage of participants
Interval 29.1 to 47.3
|
28.1 Percentage of participants
Interval 19.0 to 37.1
|
21.4 Percentage of participants
Interval 13.2 to 29.6
|
Adverse Events
Dapagliflozin 2.5mg BID Plus Metformin
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Dapagliflozin 5mg BID Plus Metformin
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Dapagliflozin 10mg OD Plus Metformin
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Plus Metformin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=100 participants at risk
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=100 participants at risk
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=99 participants at risk
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=101 participants at risk
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.0%
1/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.0%
1/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.0%
1/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
1.0%
1/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Infections and infestations
ENDOMETRITIS
|
1.0%
1/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.0%
1/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.0%
1/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
Other adverse events
| Measure |
Dapagliflozin 2.5mg BID Plus Metformin
n=100 participants at risk
Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 5mg BID Plus Metformin
n=100 participants at risk
Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Dapagliflozin 10mg OD Plus Metformin
n=99 participants at risk
Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
Placebo Plus Metformin
n=101 participants at risk
Placebo plus Metformin, oral, twice daily, \>=1500mg total daily dose
|
|---|---|---|---|---|
|
Infections and infestations
INFLUENZA
|
5.0%
5/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
2.0%
2/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
3.0%
3/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Vascular disorders
HYPERTENSION
|
3.0%
3/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/100 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
4.0%
4/99 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
5.9%
6/101 • Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 16 weeks double-blind treatment period plus 4 days / 30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER