Table 2.
Effects of dapagliflozin compared with placebo on diabetes remission and metabolic risk factors. Values are means (SD) unless stated otherwise
| Dapagliflozin (n=165) | Placebo (n=163) | Intervention effect (95% CI)* | P value | |
|---|---|---|---|---|
| Primary outcome | ||||
| No (%) in diabetes remission | 73 (44) | 46 (28) | 1.56 (1.17 to 2.09) | 0.002 |
| Secondary outcomes | ||||
| Change in body weight, kg | −5.0 (4.5) | −3.2 (3.8) | −1.3 (−1.9 to −0.7) | <0.001 |
| Change in waist circumference, cm | −5.6 (5.7) | −4.9 (5.9) | −0.5 (−1.2 to 0.1) | 0.11 |
| Change in fat mass, % | −2.1 (2.8) | −1.4 (3.4) | −0.5 (−0.9 to 0) | 0.05 |
| Change in lean mass, % | 2.1 (3.2) | 1.2 (4.2) | 0.2 (−0.3 to 0.8) | 0.42 |
| Change in systolic blood pressure, mm Hg | −4.0 (12.3) | −3.6 (13.1) | −1.9 (−3.0 to −0.7) | 0.002 |
| Change in diastolic blood pressure, mm Hg | −1.4 (8.7) | −1.3 (8.8) | −0.3 (−1.2 to 0.6) | 0.47 |
| Change in fasting plasma glucose, mg/dL | −23.4 (25.0) | −13.8 (29.1) | −9.2 (−11.8 to −6.7) | <0.001 |
| Change in HbA1c, % | −1.0 (1.0) | −0.8 (0.9) | −0.2 (−0.3 to −0.1) | 0.003 |
| Median (IQR) change in HOMA-IR | −1.8 (−3.7-−0.2) | −0.6 (−2.0-0.6) | −0.8 (−1.1 to −0.4) | <0.001 |
| Median (IQR) change in HOMA-β, % | 4.0 (−16.8-25.0) | 2.8 (−12.7-20.8) | −0.7 (−6.3 to 5.0) | 0.82 |
| Change in total cholesterol, mg/dL | 5.1 (35.4) | −1.0 (34.1) | 2.1 (−1.5 to 5.6) | 0.26 |
| Change in low density lipoprotein cholesterol, mg/dL | 0.9 (29.4) | −2.7 (31.7) | 2.1 (−1.0 to 5.2) | 0.19 |
| Change in high density lipoprotein cholesterol, mg/dL | 4.8 (6.9) | 2.3 (6.2) | 1.3 (0.4 to 2.2) | 0.003 |
| Change in triglycerides, mg/dL | −17.3 (−62.0-7.1) | −4.4 (−35.4-20.4) | −16.4 (−31.3 to −1.6) | 0.03 |
CI=confidence interval; HbA1c=glycated haemoglobin; HOMA-IR=homoeostasis model assessment of insulin resistance; HOMA-β=homoeostasis model assessment of β cell function; IQR=interquartile range; SD=standard deviation.
Risk ratio (95% CI) for primary outcome. Estimated mean difference (95% CI) for secondary outcomes; that is, effect of dapagliflozin minus that of placebo, from mixed effects linear regression model with metformin treatment as stratification factor, study centre as random effect, and baseline value, treatment group, time, and their interaction as fixed effects. Changes in each group are defined as values measured when diabetes remission was determined (2 months after either dapagliflozin or placebo was stopped) minus those measured at baseline; in participants who discontinued trial in advance or did not meet drug stopping criteria, changes are reported as values measured at final visit minus those measured at baseline.