1Division of Endocrinology and Metabolism, Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University, Seoul, Korea
2Division of Endocrinology and Metabolism, Department of Internal Medicine, Bundang Jesaeng Hospital, Seongnam, Korea
3Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Seoul, Korea
4Division of Endocrinology and Metabolism, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
5Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea
6Division of Endocrinology and Metabolism, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea
7Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea
8Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea
9Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea
10Clinical Development Center, Daewoong Pharmaceutical Co. Ltd., Seoul, Korea
11Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
Copyright © 2023 Korean Diabetes Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Characteristic | Enavogliflozin 0.3 mg (n=101) | Dapagliflozin 10 mg (n=99) |
---|---|---|
Age, yr | 59.03±11.45 | 60.35±10.62 |
Male sex | 59 (58.42) | 54 (54.55) |
Body weight, kg | 70.74±11.19 | 69.99±12.09 |
Body mass index, kg/m2 | 26.45±3.30 | 26.20±3.48 |
eGFR, mL/min/1.73 m2 | 88.06±15.72 |
94.72±18.75 |
eGFR <90 mL/min/1.73 m2 | 61 (60.40) |
46 (46.46) |
HbA1c, % | 7.82±0.74 | 7.81±0.74 |
HbA1c ≥8% | 31 (30.69) | 31 (31.31) |
FPG, mg/dL | 162.34±32.26 | 156.22±31.99 |
Duration of diabetes, yr | 8.94±5.96 | 8.18±5.65 |
Oral antidiabetic drugs | ||
Metformin alone | 59 (58.42) | 59 (59.60) |
Add-on therapy to metformin | 42 (41.58) | 40 (40.40) |
Metformin dose, mg | 1,369.55±399.82 | 1,389.90±450.13 |
Variable | Enavogliflozin 0.3 mg (n=95) | Dapagliflozin 10 mg (n=90) | ||
---|---|---|---|---|
HbA1c, % | ||||
Baseline | 7.75 (0.82) | 7.68 (0.73) | ||
Week 24 | 6.98 (0.61) | 6.97 (0.72) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | –0.80 (0.06) | –0.75 (0.06) | ||
LS mean difference (95% CI) | –0.04 (–0.21 to 0.12) | |||
FPG, mg/dL | ||||
Baseline | 145.35 (26.60) | 149.33 (31.85) | ||
Week 24 | 113.58 (17.21) | 117.91 (19.38) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | –32.53 (1.76) | –29.14 (1.82) | ||
LS mean difference (95% CI), P value | –3.38 (–8.15 to 1.39), P=0.1633 | |||
Systolic blood pressure, mm Hg | ||||
Baseline | 129.72 (13.64) | 127.44 (14.12) | ||
Week 24 | 123.38 (12.55) | 121.40 (11.90) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | –5.93 (1.01) | –6.57 (1.04) | ||
LS mean difference (95% CI), P value | 0.63 (–2.13 to 3.39), P=0.6512 | |||
Diastolic blood pressure, mm Hg | ||||
Baseline | 77.04 (9.72) | 75.92 (10.50) | ||
Week 24 | 71.65 (9.39) | 72.05 (8.44) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | –5.41 (0.65) | –4.26 (0.67) | ||
LS mean difference (95% CI), P value | –1.15 (–2.94 to 0.63), P=0.2044 | |||
Body weight, kg | ||||
Baseline | 70.17 (11.06) | 70.52 (11.81) | ||
Week 24 | 66.39 (10.90) | 66.92 (11.89) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | –3.77 (0.33) | –3.58 (0.34) | ||
LS mean difference (95% CI), P value | –0.18 (–1.08 to 0.71), P=0.6840 | |||
UACR, mg/g | ||||
Baseline | 38.19 (163.98) | 57.42 (198.64) | ||
Week 24 | 19.93 (29.10) | 31.37 (76.71) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | –24.29 (3.38) | –17.37 (3.48) |
||
LS mean difference (95% CI), P value | –6.93 (–16.14 to 2.29), P=0.1399 | |||
UGCR, g/g | ||||
Baseline | 1.54 (8.70) | 1.83 (7.49) | ||
Week 24 | 60.43 (20.76) | 45.27 (20.91) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | 60.48 (2.12) | 44.94 (2.18) |
||
LS mean difference (95% CI), P value | 15.54 (9.77 to 21.31), P<0.0001 | |||
HOMA-β | ||||
Baseline | 45.53 (36.34) | 44.44 (25.03) | ||
Week 24 | 52.32 (40.75) | 56.67 (38.17) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | 6.94 (3.17) | 11.93 (3.25) | ||
LS mean difference (95% CI), P value | –4.99 (–13.60 to 3.62), P=0.2545 | |||
HOMA-IR | ||||
Baseline | 3.45 (3.42) | 3.85 (2.49) | ||
Week 24 | 1.76 (1.07) | 2.39 (1.67) | ||
Change from baseline at week 24 | ||||
LS mean (SE) | –1.85 (0.13) | –1.31 (0.14) | ||
LS mean difference (95% CI), P value | –0.53 (–0.90 to –0.17), P=0.0041 |
System organ class (preferred term) | Enavogliflozin 0.3 mg (n=101) | Dapagliflozin 10 mg (n=99) | |
---|---|---|---|
Patients with TEAEs | 24 (23.76) [36] | 22 (22.22) [34] | |
Patients with ADRs | 1 (0.99) [1] | 7 (7.07) [7] | |
Dyspepsia | 0 | 2 (2.02) [2] |
|
Cystitis | 1 (0.99) [1] |
1 (1.01) [1] |
|
Hypoglycemia | 0 | 1 (1.01) [1] |
|
Pollakiuria | 0 | 1 (1.01) [1] |
|
Vulvovaginal pruritus | 0 | 1 (1.01) [1] |
|
Pruritus | 0 | 1 (1.01) [1] |
|
Patients with SAEs | 1 (0.99) [1] | 1 (1.01) [2] | |
Mechanical ileus | 1 (0.99) [1] |
0 | |
Benign prostatic hyperplasia | 0 | 1 (1.01) [1] |
|
Prostate cancer | 0 | 1 (1.01) [1] |
Values are presented as mean±standard deviation or number (%). Data were analyzed using the randomized set. eGFR, estimated glomerular filtration rate; HbA1c, glycosylated hemoglobin; FPG, fasting plasma glucose. Statistically significant between-group difference ( Statistically significant between-group difference (
Values are presented as the per-protocol set except blood pressure results which were presented with the modified per-protocol set 2. HbA1c, glycosylated hemoglobin; SE, standard error; CI, confidence interval; FPG, fasting plasma glucose; UACR, urine albumin-creatinine ratio; UGCR, urine glucose-creatinine ratio; HOMA-β, homeostasis model assessment of β-cell function; HOMA-IR, homeostasis model assessment of insulin resistance. As one patient did not have baseline value, total 89 patients’ data were used for calculation of change from baseline.
Values are presented as number (%) [number of events]. Data were analyzed using the safety set. TEAE, treatment-emergent adverse event; ADR, adverse drug reaction; SAE, serious adverse event. Adverse event of mild in intensity, Adverse event of moderate in intensity, Adverse event of severe in intensity.