Journal of Endocrinology and Metabolism, ISSN 1923-2861 print, 1923-287X online, Open Access |
Article copyright, the authors; Journal compilation copyright, J Endocrinol Metab and Elmer Press Inc |
Journal website http://www.jofem.org |
Original Article
Volume 9, Number 3, June 2019, pages 51-62
Efficacy and Safety of Ipragliflozin in Patients With Type 2 Diabetes: ASSIGN-K Study
Figures
Tables
Item | N = 451 |
---|---|
aMean ± standard deviation. BMI: body mass index; HbA1c: hemoglobin A1c. | |
Sex | |
Male, n (%) | 234 (51.9) |
Female, n (%) | 217 (48.1) |
Age, years | 55.5 ± 11.6a |
Duration of diabetes, years | 9.7 ± 7.4a |
HbA1c (%) | 8.01 ± 1.43a |
Fasting blood glucose (mg/dL) | 156.4 ± 48.1a |
BMI (kg/ m2) | 29.4 ± 5.3a |
Weight (kg) | 78.6 ± 16.8a |
Waist circumference (cm) | 99.8 ± 12.0a |
Complications of diabetes | |
Diabetic nephropathy, n (%) | 131 (29.0) |
Cataract, n (%) | 76 (16.9) |
Diabetic retinopathy, n (%) | 62 (13.7) |
Diabetic neuropathy, n (%) | 60 (13.3) |
Lifestyle-related diseases | |
Dyslipidemia, n (%) | 294 (65.2) |
Hypertension, n (%) | 259 (57.4) |
Fatty liver, n (%) | 218 (48.3) |
Order | Independent variable | Standardized beta coefficient | Partial regression coefficient | P value |
---|---|---|---|---|
Adjusted R2 = 0.425. Dependent variable: change of HbA1c (week 104 - baseline). Independent variables: sex (0: male, 1: female), age, duration of diabetes, baseline HbA1c, and baseline BMI. BMI: body mass index; HbA1c: hemoglobin A1c. | ||||
Fixed number | 0 | 2.835 | < 0.0001 | |
1 | Baseline HbA1c | -0.646 | -0.583 | < 0.0001 |
2 | Baseline BMI | 0.13 | 0.033 | < 0.0088 |
3 | Duration of diabetes | 0.124 | 0.021 | 0.0118 |
4 | Sex (0: male, 1: female) | 0.08 | 0.21 | 0.0874 |
5 | Age | -0.034 | -0.004 | 0.5197 |
Number of patients | Incidence (%) | |
---|---|---|
AEs | ||
AEs in all patients (n = 451) | 129 | 28.6 |
AEs requiring hospitalization | 10 | 2.2 |
ARs | ||
ARs in all patients (n = 451) | 77 | 17.1 |
ARs in patients < 65 years old (n = 348) | 50 | 14.4 |
ARs in patients ≥ 65 years old (n = 103) | 27 | 26.2 |
AE term | Number of patients | AE term | Number of patients |
---|---|---|---|
aPatients aged ≥ 65 years. AE: adverse event; AR: adverse reaction. | |||
Pyelitisa | 1 | Ketosisa | 1 |
Urinary tract infectiona | 1 | Dehydrationa | 1 |
Angina unstable | 1 | Ureterolithiasisa | 1 |
Nauseaa | 1 | Depressive symptoms | 1 |
Lung cancera | 1 | - | - |