Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00357370 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 From Baseline to Week 12 | Dapagliflozin 10 mg | -0.61 % of hemoglobin (±0.1276 Standard Error) |
| Dapagliflozin 20 mg | -0.69 % of hemoglobin (±0.1278 Standard Error) | |||
| Placebo | 0.09 % of hemoglobin (±0.1406 Standard Error) | |||
| NCT00528372 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1 Baseline to Week 24 (end of Short-term Period) | Group 1: Dapagliflozin Placebo AM & PM | -0.23 Percent (±0.1044 Standard Error) |
| Group 1: Dapagliflozin, 10 mg AM | -0.89 Percent (±0.1099 Standard Error) | |||
| Group 1: Dapagliflozin, 10 mg PM | -0.79 Percent (±0.1037 Standard Error) | |||
| Group 1: Dapagliflozin, 2.5 mg AM | -0.58 Percent (±0.1107 Standard Error) | |||
| Group 1: Dapagliflozin, 2.5 mg PM | -0.83 Percent (±0.1125 Standard Error) | |||
| Group 1: Dapagliflozin, 5 mg AM | -0.77 Percent (±0.1134 Standard Error) | |||
| Group 1: Dapagliflozin, 5 mg PM | -0.79 Percent (±0.1117 Standard Error) | |||
| NCT00528372 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2 Baseline to Week 24 (end of Short-term Period) | Group 2: Dapagliflozin, 10 mg AM | -2.66 Percent (±1.261 Standard Deviation) |
| Group 2: Dapagliflozin, 5 mg AM | -2.88 Percent (±1.406 Standard Deviation) | |||
| NCT00528879 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 | Dapagliflozin, 10 mg + Metformin | -0.84 Percent (±0.0724 Standard Error) |
| Dapagliflozin, 2.5 mg + Metformin | -0.67 Percent (±0.0715 Standard Error) | |||
| Dapagliflozin, 5 mg + Metformin | -0.70 Percent (±0.0722 Standard Error) | |||
| Placebo + Metformin | -0.30 Percent (±0.0718 Standard Error) | |||
| NCT00643851 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 | Dapagliflozin 5 mg | -1.19 % of hemoglobin (±0.0866 Standard Error) |
| Dapagliflozin 5 mg + Metformin XR | -2.05 % of hemoglobin (±0.0892 Standard Error) | |||
| Metformin XR | -1.35 % of hemoglobin (±0.0868 Standard Error) | |||
| NCT00660907 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels Baseline to Week 52 | Dapagliflozin Plus Metformin | -0.52 percent |
| Glipizide Plus Metformin | -0.52 percent | |||
| NCT00663260 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF] From Baseline to Week 24 | Dapagliflozin 10 mg | -0.44 % of hemoglobin (±0.1708 Standard Error) |
| Dapagliflozin 5 mg | -0.41 % of hemoglobin (±0.1701 Standard Error) | |||
| Placebo | -0.32 % of hemoglobin (±0.1701 Standard Error) | |||
| NCT00673231 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels Baseline to Week 24 | Dapagliflozin 10mg | -0.90 Percent |
| Dapagliflozin 2.5mg | -0.75 Percent | |||
| Dapagliflozin 5mg | -0.82 Percent | |||
| Placebo | -0.30 Percent | |||
| NCT00680745 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels Baseline to Week 24 | Dapagliflozin 10mg + Glimepiride | -0.82 Percent |
| Dapagliflozin 2.5mg + Glimepiride | -0.58 Percent | |||
| Dapagliflozin 5mg + Glimepiride | -0.63 Percent | |||
| Placebo + Glimepiride | -0.13 Percent | |||
| NCT00683878 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 | Dapagliflozin 10MG + Pioglitazone | -0.97 % of hemoglobin (±0.0828 Standard Error) |
| Dapagliflozin 5MG + Pioglitazone | -0.82 % of hemoglobin (±0.0828 Standard Error) | |||
| PLACEBO + Pioglitazone | -0.42 % of hemoglobin (±0.0834 Standard Error) | |||
| NCT00736879 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants Baseline (Day 1), Week 24 | Dapagliflozin 1mg | -0.68 Percent Hemoglobin (±0.1166 Standard Error) |
| Dapagliflozin 2.5 mg | -0.72 Percent Hemoglobin (±0.1169 Standard Error) | |||
| Dapagliflozin 5 mg | -0.82 Percent Hemoglobin (±0.1217 Standard Error) | |||
| Placebo | 0.02 Percent Hemoglobin (±0.1200 Standard Error) | |||
| NCT00855166 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in Total Body Weight Baseline to Week 24 | Dapagliflozin Plus Metformin | -2.96 kg (±0.2766 95% Confidence Interval) |
| Placebo Plus Metformin | -0.88 kg (±0.2746 95% Confidence Interval) | |||
| NCT00859898 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants Week 24 | Dapagliflozin | -1.45 Percent of hemoglobin (±0.0734 Standard Error) |
| Dapagliflozin + Metformin XR | -1.98 Percent of hemoglobin (±0.0759 Standard Error) | |||
| Metformin XR | -1.44 Percent of hemoglobin (±0.0757 Standard Error) | |||
| NCT00984867 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels Baseline to Week 24 | Dapagliflozin | -0.45 Percent (±0.0509 95% Confidence Interval) |
| Placebo | 0.04 Percent (±0.0509 95% Confidence Interval) | |||
| NCT01031680 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels Baseline to Week 24 | Experimental | -0.38 Percent |
| Placebo Comparator | 0.08 Percent | |||
| NCT01031680 | Diabetes Mellitus, Type 2 | Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit Baseline to week 24 | Experimental | 11.7 Percentage of participants |
| Placebo Comparator | 0.9 Percentage of participants | |||
| NCT01042977 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels Baseline to Week 24 | Dapagliflozin | -0.33 Percent (±0.0434 95% Confidence Interval) |
| Placebo | 0.07 Percent | |||
| NCT01042977 | Diabetes Mellitus, Type 2 | Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit Baseline to Week 24 | Dapagliflozin | 10.0 Percentage of participants (±0.7 95% Confidence Interval) |
| Placebo | 1.9 Percentage of participants (±7.3 95% Confidence Interval) | |||
| NCT01095653 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 | Dapagliflozin 10 mg | -1.11 % of hemoglobin (±0.0680 Standard Error) |
| Dapagliflozin 5 mg | -1.04 % of hemoglobin (±0.0695 Standard Error) | |||
| Placebo | -0.29 % of hemoglobin (±0.0681 Standard Error) | |||
| NCT01095666 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 | Dapagliflozin 10 mg + Metformin | -0.85 % of hemoglobin (±0.0601 Standard Error) |
| Dapagliflozin 5 mg + Metformin | -0.82 % of hemoglobin (±0.0607 Standard Error) | |||
| Placebo + Metformin | -0.23 % of hemoglobin (±0.0622 Standard Error) | |||
| NCT01137474 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12 From Baseline to Week 12 | Dapagliflozin 10 mg | -0.56 Percent (±0.0633 Standard Error) |
| Placebo | -0.10 Percent (±0.0631 Standard Error) | |||
| NCT01137474 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 From Baseline to Week 12 | Dapagliflozin 10 mg | -10.40 mm Hg (±0.8822 Standard Error) |
| Placebo | -7.34 mm Hg (±0.8812 Standard Error) | |||
| NCT01195662 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants Baseline to Week 12 | Dapagliflozin 10 mg | -0.41 Percent of Hemoglobin (±0.0496 Standard Error) |
| Dapagliflozin 10 mg | -0.58 Percent of Hemoglobin (±0.0602 Standard Error) | |||
| Dapagliflozin 10 mg | -0.63 Percent of Hemoglobin (±0.0668 Standard Error) | |||
| Placebo Matching Dapagliflozin | -0.06 Percent of Hemoglobin (±0.0498 Standard Error) | |||
| Placebo Matching Dapagliflozin | -0.07 Percent of Hemoglobin (±0.0606 Standard Error) | |||
| Placebo Matching Dapagliflozin | -0.02 Percent of Hemoglobin (±0.0673 Standard Error) | |||
| NCT01195662 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants Baseline to Week 12 | Dapagliflozin 10 mg | -9.69 mmHg (±1.0097 Standard Error) |
| Dapagliflozin 10 mg | -11.38 mmHg (±1.0251 Standard Error) | |||
| Dapagliflozin 10 mg | -7.93 mmHg (±0.9357 Standard Error) | |||
| Dapagliflozin 10 mg | -11.90 mmHg (±1.0585 Standard Error) | |||
| Placebo Matching Dapagliflozin | -6.05 mmHg (±1.0232 Standard Error) | |||
| Placebo Matching Dapagliflozin | -6.80 mmHg (±1.0374 Standard Error) | |||
| Placebo Matching Dapagliflozin | -7.62 mmHg (±1.0701 Standard Error) | |||
| Placebo Matching Dapagliflozin | -5.13 mmHg (±0.9489 Standard Error) | |||
| NCT01217892 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels Baseline to Week 16 | Dapagliflozin 10mg OD Plus Metformin | -0.59 Percent (±0.0598 Standard Error) |
| Dapagliflozin 2.5mg BID Plus Metformin | -0.52 Percent (±0.0594 Standard Error) | |||
| Dapagliflozin 5mg BID Plus Metformin | -0.65 Percent (±0.0600 Standard Error) | |||
| Placebo Plus Metformin | -0.30 Percent (±0.0593 Standard Error) | |||
| NCT01294423 | Diabetes Mellitus, Type 2 | Adjusted Mean Change in HbA1c Levels From Baseline to Week 24 | Dapagliflozin 10 mg | -0.45 Percent |
| Dapagliflozin 5 mg | -0.41 Percent | |||
| Placebo | -0.06 Percent | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Alanine Aminotransferase (ALT) Baseline to Week 52 | All Combination Therapies | -5.4 U/L (±0.622 Standard Error) |
| Monotherapy | -7.1 U/L (±0.955 Standard Error) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Aspartate Aminotransferase (AST) Baseline to Week 52 | All Combination Therapies | -2.6 U/L (±0.410 Standard Error) |
| Monotherapy | -3.9 U/L (±0.695 Standard Error) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Blood Urea Nitrogen (BUN) Baseline to Week 52 | All Combination Therapies | 2.3 mg/dL (±0.168 Standard Error) |
| Monotherapy | 2.4 mg/dL (±0.250 Standard Error) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Hematocrit Baseline to Week 52 | All Combination Therapies | 2.00 Percent (±0.1115 Standard Error) |
| Monotherapy | 2.17 Percent (±0.1396 Standard Error) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Magnesium Baseline to Week 52 | All Combination Therapies | 0.05 mEq/L (±0.0064 Standard Error) |
| Monotherapy | 0.05 mEq/L (±0.0074 Standard Error) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Seated Diastolic Blood Pressure Baseline to Week 52 | All Combination Therapies | -2.1 mmHg (±8.73 Standard Deviation) |
| Monotherapy | -2.9 mmHg (±8.16 Standard Deviation) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Seated Heart Rate Baseline to Week 52 | All Combination Therapies | 0.2 beats per minute (bpm) (±7.95 Standard Deviation) |
| Monotherapy | -0.4 beats per minute (bpm) (±7.52 Standard Deviation) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Seated Systolic Blood Pressure Baseline to Week 52 | All Combination Therapies | -3.9 mmHg (±13.03 Standard Deviation) |
| Monotherapy | -5.2 mmHg (±11.68 Standard Deviation) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Mean Change in Serum Uric Acid Baseline to Week 52 | All Combination Therapies | -0.50 mg/dL (±0.0374 Standard Error) |
| Monotherapy | -0.61 mg/dL (±0.0578 Standard Error) | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Proportion of Participants With Adverse Events Long-term treatment up to 52 weeks | All Combination Therapies | 72.4 Percentage of participants |
| Monotherapy | 79.1 Percentage of participants | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Proportion of Participants With At Least One Episode of Hypoglycemia Long-term treatment up to 52 weeks | All Combination Therapies | 4.0 Percentage of participants |
| Monotherapy | 2.4 Percentage of participants | |||
| NCT01294436 | Diabetes Mellitus, Type 2 | Proportion of Participants With Serious Adverse Events Long-term treatment up to 52 weeks | All Combination Therapies | 3.1 Percentage of participants |
| Monotherapy | 5.6 Percentage of participants | |||
| NCT01392677 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in HbA1c Levels Baseline to week 24 | Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -0.86 Percent |
| Placebo Plus Metformin Plus Sulfonylurea | -0.17 Percent | |||
| NCT01606007 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 Baseline (Week 0) and at Week 24 | Arm 1: Saxagliptin+Metformin XR+Placebo | -0.88 % HbA1c |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -1.20 % HbA1c | |||
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -1.47 % HbA1c | |||
| NCT01619059 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 From Baseline to Week 24 | Placebo + Dapagliflozin 10mg + Metformin | -0.16 Percent of glycosylated haemoglobin (±0.0605 Standard Error) |
| Saxagliptin 5mg + Dapagliflozin 10mg + Metformin | -0.51 Percent of glycosylated haemoglobin (±0.0624 Standard Error) | |||
| NCT01646320 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 From Baseline to Week 24 | Dapa+Saxa+Met | -0.82 Percentage of glycosylated hemoglobin (±0.0686 Standard Error) |
| Pla+Saxa+Met | -0.1 Percentage of glycosylated hemoglobin (±0.0704 Standard Error) | |||
| NCT01730534 DECLARE-TIMI58 | Diabetes Mellitus, Type 2 | Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. up to 5.2 years | Dapa 10 mg | 417 Participants |
| Placebo | 496 Participants | |||
| NCT01730534 DECLARE-TIMI58 | Diabetes Mellitus, Type 2 | Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke up to 5.2 years | Dapa 10 mg | 756 Participants |
| Placebo | 803 Participants | |||
| NCT02096705 | Diabetes Mellitus | Adjusted Mean Change in HbA1c From Baseline to Week 24 Baseline (Day 1) and 24 weeks | Dapagliflozin | -0.87 percentage of hemoglobin (±0.0666 Standard Error) |
| Placebo | 0.03 percentage of hemoglobin (±0.0707 Standard Error) | |||
| NCT02113241 | Insulin Resistance | Diastolic Blood Pressure at Week 12. Week 12 | Dapagliflozin | 76 mmHg (±8 Standard Deviation) |
| Placebo | 79 mmHg (±10 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | Glucose Levels at Minute 0 at Week 12. Week 12 | Dapagliflozin | 5.7 mmol/L (±1.1 Standard Deviation) |
| Placebo | 5.8 mmol/L (±0.7 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | High Density Lipoprotein (c-HDL) Levels at Week 12. Week 12 | Dapagliflozin | 1.3 mmol/L (±0.2 Standard Deviation) |
| Placebo | 1.3 mmol/L (±0.2 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | Insulinogenic Index (Total Insulin Secretion) at Week 12. Week 12 | Dapagliflozin | 0.35 index (±0.11 Standard Deviation) |
| Placebo | 0.99 index (±0.38 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | Matsuda Index (Total Insulin Sensitivity) at Week 12. Week 12 | Dapagliflozin | 2.7 index (±1.4 Standard Deviation) |
| Placebo | 1.6 index (±0.8 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | Stumvoll Index (First Phase of Insulin Secretion) at Week 12. Week 12 | Dapagliflozin | 1463 index (±879 Standard Deviation) |
| Placebo | 2198 index (±996 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | Systolic Blood Pressure at Week 12. Week 12 | Dapagliflozin | 117 mmHg (±10 Standard Deviation) |
| Placebo | 121 mmHg (±13 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | Triglycerides Levels at Week 12. Week 12 | Dapagliflozin | 1.7 mmol/L (±0.8 Standard Deviation) |
| Placebo | 1.7 mmol/L (±0.6 Standard Deviation) | |||
| NCT02113241 | Insulin Resistance | Waist Circumference at Week 12. Week 12 | Dapagliflozin | 97.6 centimeters (±8.9 Standard Deviation) |
| Placebo | 97.2 centimeters (±6.9 Standard Deviation) | |||
| NCT02229396 | Diabetes Mellitus | Change in HbA1c From Baseline to Week 28 Baseline to Week 28 | Dapagliflozin + Placebo | -1.39 % HbA1c |
| Exenatide + Dapagliflozin | -1.98 % HbA1c | |||
| Exenatide + Placebo | -1.60 % HbA1c | |||
| NCT02268214 DEPICT 1 | Diabetes Mellitus, Type 1 | Adjusted Mean Change in HbA1c From Baseline at Week 24 From Baseline to Week 24 | Dapagliflozin 10 mg + Insulin | -0.47 Percentage of hemoglobin (±0.0538 Standard Error) |
| Dapagliflozin 5 mg + Insulin | -0.45 Percentage of hemoglobin (±0.0537 Standard Error) | |||
| Placebo + Insulin | -0.03 Percentage of hemoglobin (±0.0540 Standard Error) | |||
| NCT02284893 | Diabetes Mellitus, Type 2 | Mean Change in HbA1c Baseline (randomization) to Week 26 | Saxagliptin + Dapagliflozin + Metformin Group | -1.41 percentage (%) (±0.0696 Standard Error) |
| SITA + MET | -1.07 percentage (%) (±0.0719 Standard Error) | |||
| NCT02413398 DERIVE | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Baseline, Week 24 | Dapagliflozin | -0.37 percent (±0.10 Standard Error) |
| Placebo | -0.03 percent (±0.10 Standard Error) | |||
| NCT02419612 | Diabetes Mellitus | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 Baseline and Week 52 | Dapagliflozin 10mg and Saxagliptin 5mg | -1.35 % HbA1c |
| Titrated Glimepiride | -0.98 % HbA1c | |||
| NCT02460978 DEPICT 2 | Diabetes Mellitus, Type 1 | Adjusted Mean Change From Baseline in HbA1c at Week 24 Baseline and 24 weeks | DAPA 10 MG + INS | -0.39 HbA1c (%) |
| DAPA 5 MG + INS | -0.34 HbA1c (%) | |||
| PLA + INS | 0.03 HbA1c (%) | |||
| NCT02518945 | Diabetes Mellitus, Type 1 | Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo. 12 weeks | Active Drugs | -0.66 % HbA1c (±0.1 Standard Error) |
| Placebo | 0 % HbA1c (±0.2 Standard Error) | |||
| NCT02532855 | Diabetes Mellitus, Type 2 | Change From Baseline in A1C at Week 24 Baseline and Week 24 | Dapagliflozin | -0.36 Percent A1C |
| Sitagliptin | -0.51 Percent A1C | |||
| NCT02532855 | Diabetes Mellitus, Type 2 | Percentage of Participants Who Discontinued Study Drug Due to an AE Up to 24 weeks | Dapagliflozin | 3.3 Percentage of participants |
| Sitagliptin | 3.3 Percentage of participants | |||
| NCT02532855 | Diabetes Mellitus, Type 2 | Percentage of Participants Who Experienced One or More Adverse Events Up to 26 weeks | Dapagliflozin | 51.6 Percentage of participants |
| Sitagliptin | 48.9 Percentage of participants | |||
| NCT02547935 | Diabetes Mellitus, Type 2 | Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 Baseline and Week 24 | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | -0.85 Percentage of Glycoslyated HbA1c (±0.09 Standard Error) |
| Placebo | -0.27 Percentage of Glycoslyated HbA1c (±0.09 Standard Error) | |||
| NCT02547935 | Diabetes Mellitus, Type 2 | Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24 Baseline and Week 24 | Dapagliflozin 10 mg | -22.4 Percent change (±6.6 Standard Error) |
| Dapagliflozin 10 mg + Saxagliptin 2.5 mg | -39.1 Percent change (±5.1 Standard Error) | |||
| Placebo | -1.8 Percent change (±8.3 Standard Error) | |||
| NCT02551874 | Diabetes Mellitus, Type 2 | Mean Change From Baseline in HbA1c at Week 24 Baseline and Week 24 | Dapagliflozin + Saxagliptin + Metformin | -1.67 % HbA1c |
| Titrated Insulin + Metformin | -1.54 % HbA1c | |||
| NCT02582814 | Diabetes Mellitus, Type 1 | Clinical Laboratory Measures, Urine Test Results (Any Marked Abnormality) From baseline to 52 weeks | Dapagliflozin 10mg + Insulin | 1 Participants |
| Dapagliflozin 10mg + Insulin | 1 Participants | |||
| Dapagliflozin 10mg + Insulin | 0 Participants | |||
| Dapagliflozin 10mg + Insulin | 1 Participants | |||
| Dapagliflozin 10mg + Insulin | 1 Participants | |||
| Dapagliflozin 10mg + Insulin | 0 Participants | |||
| Dapagliflozin 10mg + Insulin | 1 Participants | |||
| Dapagliflozin 5mg + Insulin | 1 Participants | |||
| Dapagliflozin 5mg + Insulin | 1 Participants | |||
| Dapagliflozin 5mg + Insulin | 2 Participants | |||
| Dapagliflozin 5mg + Insulin | 0 Participants | |||
| Dapagliflozin 5mg + Insulin | 1 Participants | |||
| Dapagliflozin 5mg + Insulin | 1 Participants | |||
| Dapagliflozin 5mg + Insulin | 0 Participants | |||
| NCT02582814 | Diabetes Mellitus, Type 1 | Diabetic Ketoacidosis (DKA) From baseline to 52 weeks | Dapagliflozin 10mg + Insulin | 0 Participants |
| Dapagliflozin 10mg + Insulin | 0 Participants | |||
| Dapagliflozin 10mg + Insulin | 1 Participants | |||
| Dapagliflozin 5mg + Insulin | 2 Participants | |||
| Dapagliflozin 5mg + Insulin | 1 Participants | |||
| Dapagliflozin 5mg + Insulin | 0 Participants | |||
| NCT02582814 | Diabetes Mellitus, Type 1 | ECGs From baseline to 52 weeks | Dapagliflozin 10mg + Insulin | 8 Participants |
| Dapagliflozin 10mg + Insulin | 67 Participants | |||
| Dapagliflozin 10mg + Insulin | 0 Participants | |||
| Dapagliflozin 10mg + Insulin | 0 Participants | |||
| Dapagliflozin 10mg + Insulin | 8 Participants | |||
| Dapagliflozin 10mg + Insulin | 67 Participants | |||
| Dapagliflozin 5mg + Insulin | 2 Participants | |||
| Dapagliflozin 5mg + Insulin | 69 Participants | |||
| Dapagliflozin 5mg + Insulin | 0 Participants | |||
| Dapagliflozin 5mg + Insulin | 5 Participants | |||
| Dapagliflozin 5mg + Insulin | 65 Participants | |||
| Dapagliflozin 5mg + Insulin | 11 Participants | |||
| NCT02582814 | Diabetes Mellitus, Type 1 | Hypoglycemia From baseline to 52 weeks | Dapagliflozin 10mg + Insulin | 11 Participants |
| Dapagliflozin 10mg + Insulin | 75 Participants | |||
| Dapagliflozin 10mg + Insulin | 5 Participants | |||
| Dapagliflozin 10mg + Insulin | 73 Participants | |||
| Dapagliflozin 10mg + Insulin | 64 Participants | |||
| Dapagliflozin 10mg + Insulin | 14 Participants | |||
| Dapagliflozin 5mg + Insulin | 2 Participants | |||
| Dapagliflozin 5mg + Insulin | 67 Participants | |||
| Dapagliflozin 5mg + Insulin | 60 Participants | |||
| Dapagliflozin 5mg + Insulin | 13 Participants | |||
| Dapagliflozin 5mg + Insulin | 14 Participants | |||
| Dapagliflozin 5mg + Insulin | 75 Participants | |||
| NCT02582814 | Diabetes Mellitus, Type 1 | Overall Adverse Event Summary From baseline to 52 weeks | Dapagliflozin 10mg + Insulin | 0 Participants |
| Dapagliflozin 10mg + Insulin | 22 Participants | |||
| Dapagliflozin 10mg + Insulin | 3 Participants | |||
| Dapagliflozin 10mg + Insulin | 55 Participants | |||
| Dapagliflozin 10mg + Insulin | 4 Participants | |||
| Dapagliflozin 5mg + Insulin | 4 Participants | |||
| Dapagliflozin 5mg + Insulin | 23 Participants | |||
| Dapagliflozin 5mg + Insulin | 67 Participants | |||
| Dapagliflozin 5mg + Insulin | 0 Participants | |||
| Dapagliflozin 5mg + Insulin | 7 Participants | |||
| NCT02582814 | Diabetes Mellitus, Type 1 | Vital Signs (Blood Pressure) From baseline to 52 weeks | Dapagliflozin 10mg + Insulin | -2.9 mmHg (±12.55 Standard Deviation) |
| Dapagliflozin 10mg + Insulin | -1.0 mmHg (±7.89 Standard Deviation) | |||
| Dapagliflozin 5mg + Insulin | -3.4 mmHg (±11.41 Standard Deviation) | |||
| Dapagliflozin 5mg + Insulin | -0.6 mmHg (±8.21 Standard Deviation) | |||
| NCT02582814 | Diabetes Mellitus, Type 1 | Vital Signs (Heart Rate) From baseline to 52 weeks | Dapagliflozin 10mg + Insulin | 0.4 bpm (±8.89 Standard Deviation) |
| Dapagliflozin 5mg + Insulin | -0.3 bpm (±10.07 Standard Deviation) | |||
| NCT02592421 | Diabetes Mellitus, Type 2 | Change in Endogenous Glucose Production (EGP) Baseline to 240-300 minutes | Dapagliflozin | 0.1 mg/kg.min (±0.1 Standard Deviation) |
| Dapagliflozin | -0.23 mg/kg.min (±0.09 Standard Deviation) | |||
| Dapagliflozin | -0.57 mg/kg.min (±0.12 Standard Deviation) | |||
| Placebo | -1.28 mg/kg.min (±0.17 Standard Deviation) | |||
| Placebo | -0.56 mg/kg.min (±0.1 Standard Deviation) | |||
| Placebo | -0.48 mg/kg.min (±0.05 Standard Deviation) | |||
| NCT02592421 | Diabetes Mellitus, Type 2 | Change in Plasma Glucose Concentration Baseline to 240-300 minutes | Dapagliflozin | -29.7 mg/dl (±3 Standard Deviation) |
| Dapagliflozin | 3.1 mg/dl (±0.9 Standard Deviation) | |||
| Dapagliflozin | -30.3 mg/dl (±3.5 Standard Deviation) | |||
| Placebo | -17.2 mg/dl (±2.9 Standard Deviation) | |||
| Placebo | -2.3 mg/dl (±6.1 Standard Deviation) | |||
| Placebo | 0.9 mg/dl (±1.1 Standard Deviation) | |||
| NCT02635386 | Obesity | Oral Disposition (Insulin Sensitivity-insulin Secretion) Index 24 weeks of treatment | Dapagliflozin (DAPA) | 311 index score (±90 Standard Error) |
| Dapagliflozin Plus Glucophage (MET ER) | 395 index score (±85 Standard Error) | |||
| EQW Plus DAPA | 503 index score (±80 Standard Error) | |||
| Exenatide Once Weekly (EQW ) | 471 index score (±83 Standard Error) | |||
| Phentermine /Topiramate (PHEN/ TPM) ER | 545 index score (±93 Standard Error) | |||
| NCT02681094 | Diabetes Mellitus, Type 2 | Change From Baseline in HbA1c at Week 24 Baseline and week 24 | Dapagliflozin + Metformin | -0.63 Percentage (%) (±0.0560 Standard Error) |
| Dapagliflozin + Saxagliptin + Metformin | -1.03 Percentage (%) (±0.0558 Standard Error) | |||
| Saxagliptin + Metformin | -0.69 Percentage (%) (±0.0551 Standard Error) | |||
| NCT02725593 | Diabetes Mellitus, Type 2 | Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24 Baseline to Week 24 | Dapagliflozin 10mg/ Dapagliflozin 10mg | -0.25 Percentage of HbA1c (±0.30 Standard Error) |
| Placebo/ Dapagliflozin 10mg | 0.50 Percentage of HbA1c (±0.34 Standard Error) | |||
| NCT02984644 AZ11040 | Diabetes Mellitus, Type 2 | Change in EGP With Glucose Clamp: Study 2 Baseline to 240-300 minutes | Dapagliflozin 10mg | -0.57 mg/kg.min (±0.12 Standard Deviation) |
| Placebo | -1.28 mg/kg.min (±0.172 Standard Deviation) | |||
| NCT02984644 AZ11040 | Diabetes Mellitus, Type 2 | Change in EGP With Pancreatic Clamp: Study 3 Baseline to 240-300 minutes | Dapagliflozin 10mg | -0.23 mg/kg.min (±0.09 Standard Deviation) |
| Placebo | -0.48 mg/kg.min (±0.05 Standard Deviation) | |||
| NCT02984644 AZ11040 | Diabetes Mellitus, Type 2 | Change in EGP: Study 1 Baseline to 240-300 minutes | Dapagliflozin | 0.10 mg/kg.min (±0.1 Standard Deviation) |
| Placebo | -0.56 mg/kg.min (±0.11 Standard Deviation) | |||
| NCT02984644 AZ11040 | Diabetes Mellitus, Type 2 | Change in Plasma Glucose Measurement Using a Glucose Clamp: Study 2 Baseline to 240-300 minutes | Dapagliflozin 10mg | 3 mg/dl (±1 Standard Deviation) |
| Placebo | 1 mg/dl (±1 Standard Deviation) | |||
| NCT02984644 AZ11040 | Diabetes Mellitus, Type 2 | Change in Plasma Glucose Using a Pancreatic Clamp: Study 3 Baseline to 240-300 minutes | Dapagliflozin 10mg | -30 mg/dl (±4 Standard Deviation) |
| Placebo | -7 mg/dl (±5 Standard Deviation) | |||
| NCT02984644 AZ11040 | Diabetes Mellitus, Type 2 | Measurement of the Change in Plasma Glucose (mg/dL): Study 1 Baseline to 240-300 minutes | Dapagliflozin 10mg | -29 mg/dl (±4 Standard Deviation) |
| Placebo | -17 mg/dl (±3 Standard Deviation) | |||
| NCT03036124 DAPA-HF | Heart Failure | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. Up to 27.8 months. | Dapa 10 mg | 386 Participants |
| Placebo | 502 Participants | |||
| NCT03036150 Dapa-CKD | Renal Insufficiency, Chronic | Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. Up to 38.2 months | Dapagliflozin | 197 Participants |
| Placebo | 312 Participants | |||
| NCT03199053 | Diabetes Mellitus, Type 2 | Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26 Baseline and Week 26 | Dapagliflozin | -0.62 Percentage HbA1c (±0.218 Standard Error) |
| Placebo | 0.41 Percentage HbA1c (±0.218 Standard Error) | |||
| NCT03199053 | Diabetes Mellitus, Type 2 | Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26 Baseline and Week 26 | Placebo | 0.50 Percentage HbA1c (±0.202 Standard Error) |
| Saxagliptin | 0.06 Percentage HbA1c (±0.198 Standard Error) | |||
| NCT03619213 DELIVER | — | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation Up to 42.1 months | Dapa 10 mg | 381 Participants |
| Placebo | 440 Participants | |||
| NCT03619213 DELIVER | — | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. Up to 42.1 months | Dapa 10 mg | 512 Participants |
| Placebo | 610 Participants | |||
| NCT03762850 PROTECT | Glomerulonephritis, IGA | Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 Baseline (Day 1) and at Week 36 | Irbesartan | -15.05 Percent change |
| Sparsentan | -49.77 Percent change | |||
| NCT03877224 | — | Change From Baseline in 6-minute Walk Distance (6MWD) at Week 16 (Larger Distances Represent Better Functional Capacity) At baseline and at week 16 or death before week 16 | Dapa 10mg | 9.0 meters |
| Placebo | 8.5 meters | |||
| NCT03877224 | — | Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Physical Limitation Score (KCCQ-PLS) at Week 16 (Higher Scores Represent Less Physical Limitation Due to HF) At baseline and at week 16 or death before week 16 | Dapa 10mg | 0.00 Score on a scale |
| Placebo | 0.00 Score on a scale | |||
| NCT03877224 | — | Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 16 (Higher Scores Represent Less HF Symptom Frequency and Burden) At baseline and at week 16 or death before week 16 | Dapa 10mg | 5.21 Score on a scale |
| Placebo | 1.04 Score on a scale | |||
| NCT03877237 | — | Change From Baseline in 6-minute Walk Distance (6MWD) at Week 16 (Larger Distances Represent Better Functional Capacity). At baseline and at week 16 or death prior to week 16 | Dapa 10mg | 20.0 meters |
| Placebo | 13.5 meters | |||
| NCT03877237 | — | Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Physical Limitation Score (KCCQ-PLS) at Week 16 (Higher Scores Represent Less Physical Limitation Due to HF) At baseline and at week 16 or death before week 16 | Dapa 10mg | 4.17 Score on a scale |
| Placebo | 0.00 Score on a scale | |||
| NCT03877237 | — | Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 16 (Higher Scores Represent Less HF Symptom Frequency and Burden). At baseline and at week 16 or death before week 16 | Dapa 10mg | 2.08 Score on a scale |
| Placebo | 0.00 Score on a scale | |||
| NCT03968224 | Diabetes Mellitus, Type 2 | Change in Weight 12 months | Metformin | 115 kg (±20.18 Standard Deviation) |
| Metformin | 118.4 kg (±21.4 Standard Deviation) | |||
| Metformin | 119.9 kg (±22.4 Standard Deviation) | |||
| Metformin | 120 kg (±20.58 Standard Deviation) | |||
| Metformin | 123.7 kg (±21.8 Standard Deviation) | |||
| Metformin | 125.9 kg (±23.9 Standard Deviation) | |||
| Metformin/Dapagliflozin | 115.4 kg (±17.9 Standard Deviation) | |||
| Metformin/Dapagliflozin | 116.3 kg (±20.11 Standard Deviation) | |||
| Metformin/Dapagliflozin | 114.4 kg (±17.8 Standard Deviation) | |||
| Metformin/Dapagliflozin | 116 kg (±19 Standard Deviation) | |||
| Metformin/Dapagliflozin | 121.5 kg (±21.1 Standard Deviation) | |||
| Metformin/Dapagliflozin | 118 kg (±20.8 Standard Deviation) | |||
| NCT04298229 DICTATE-AHF | Diabetes Mellitus, Type 2 | Cumulative Change in Weight (Kilograms) Per 40mg of IV Furosemide Equivalents, Adjusted for Baseline Weight Baseline to Day 5 or discharge if earlier | Dapagliflozin Plus Structured Usual Care | -0.42 kg/40mg IV furosemide |
| Structured Usual Care | -0.31 kg/40mg IV furosemide | |||
| NCT04350593 DARE-19 | COVID-19 | Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30. Randomization through Day 30 | Dapagliflozin 10mg | 547 participants |
| Placebo | 532 participants | |||
| NCT04350593 DARE-19 | COVID-19 | Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause. Randomization through Day 30 | Dapagliflozin 10mg | 12.4 Patients with events/100 pt-mos at risk |
| Placebo | 15.6 Patients with events/100 pt-mos at risk | |||
| NCT04564742 DAPA-MI | Heart Failure | Analysis of the Hierarchical Primary Composite Endpoint (Full Analysis Set) 29 months | Dapa 10 mg | 40 Participants |
| Dapa 10 mg | 41 Participants | |||
| Dapa 10 mg | 8 Participants | |||
| Dapa 10 mg | 32 Participants | |||
| Dapa 10 mg | 29 Participants | |||
| Dapa 10 mg | 1990 Participants | |||
| Dapa 10 mg | 1839 Participants | |||
| Dapa 10 mg | 684 Participants | |||
| Placebo | 41 Participants | |||
| Placebo | 32 Participants | |||
| Placebo | 74 Participants | |||
| Placebo | 468 Participants | |||
| Placebo | 33 Participants | |||
| Placebo | 15 Participants | |||
| Placebo | 1970 Participants | |||
| Placebo | 1773 Participants |