Table 3.
Primary study group | Secondary study group | |||||
---|---|---|---|---|---|---|
(Increased-dose group)—(drug-added group) | (Drug-added group)—(drug-switched group) | (Increased-dose group)—(drug-switched group) | (Increased-dose group)—(drug-added group) | (Drug-added group)—(drug-switched group) | (Increased-dose group)—(drug-switched group) | |
ΔHbA1c, 12M (%) | 0.12* | − 0.80* | − 1.12* | − 0.12* | − 0.20* | − 0.43* |
ΔHbA1c, 3M (%) | 0.19* | − 0.52* | − 0.38* | 0.03 | − 0.32* | − 0.58* |
ΔHbA1c, 6M (%) | 0.03 | − 0.46* | − 0.42* | − 0.15* | − 0.23* | − 0.58* |
ΔHDL-C (mg/dl) | − 0.09 | − 1.65 | 0.22 | − 0.40 | − 0.80 | − 0.16 |
ΔLDL-C (mg/dl) | 1.56 | 4.29 | − 4.86 | − 2.47 | 9.01 | − 1.60 |
ΔTotal-C (mg/dl) | − 2.91 | 10.65 | 8.71 | − 6.66 | 2.45 | 0.85 |
ΔTG (mg/dl) | − 10.23 | − 22.48 | − 78.30 | − 30.45 | − 6.10 | − 10.70 |
ΔAST (U/l) | − 0.58 | 1.43 | − 1.41 | − 3.43 | 7.37 | 0.51 |
ΔALT (U/l) | 2.45 | 2.61 | 1.61 | 0.98 | 7.94 | 4.78 |
ΔeGFR (ml/min/1.73 m2) | 4.03* | − 2.04 | 6.69 | 3.00 | 1.98 | 3.84 |
HbA1c < 6.5% (%) | − 1.17 | 1.06 | 7.65 | − 3.74 | − 14.76 | − 1.91 |
HbA1c < 7.0% (%) | 1.90 | − 4.97 | 6.91 | 3.84 | 12.81 | 31.00* |
Hospitalization (%) | − 3.56 | − 36.93* | − 25.33 | 15.79 | − 66.60* | 9.66 |
AST aspartate aminotransferase, ALT alanine aminotransferase, eGFR estimated glomerular filtration, Hb hemoglobin, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, Total-C total cholesterol, TG triglyceride
*95% confidence intervals do not cross 0. The changes in values at 3 months (± 1 months) (3M), 6 months (± 1 months) (6M), and 12 months (± 3 months) (12M) from baseline for HbA1c and 12 months (± 3 months) from baseline for other laboratory values are indicated using delta (Δ)