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Table 3 Cumulative incidence and rate of hypoglycemia in insulin-naïve group (N = 3732), according to patient characteristics

From: Incidence and predictors of hypoglycemia in Japanese patients with type 2 diabetes treated by insulin glargine and oral antidiabetic drugs in real-life: ALOHA post-marketing surveillance study sub-analysis

Characteristics Total patients, N Patients having hypoglycemia, n (%) P value Number needed to harm (95% CI) Patient-years Episodes, n Incidence rate (episodes/patient-year)
Age (years) <65 2046 14 (0.7) < 0.05 Reference 880.5 21 0.024
≥65 1678 27 (1.6) 108 (62–445) 714.2 36 0.050
Diabetic complications No microvascular complication 1889 18 (1.0) < 0.05 Reference 811.1 24 0.030
Neuropathy only 297 6 (2.0) 94 (n.s.) 127.9 6 0.047
Retinopathy only 318 1 (0.3) -* 138.3 1 0.007
Nephropathy only 356 2 (0.6) -* 152.5 5 0.033
Neuropathy + Retinopathy 174 1 (0.6) -* 74.9 1 0.013
Neuropathy + Nephropathy 142 0 (0.0) -* 59.5 0 0.000
Retinopathy + Nephropathy 154 5 (3.2) 44 (n.s.) 64.1 7 0.109
Neuropathy + Retinopathy + Nephropathy 301 5 (1.7) 141 (n.s.) 126.4 6 0.047
eGFR (mL/min/1.73 m2) 90≤ 933 3 (0.3) < 0.01 Reference 400.6 4 0.010
60≤, <90 1375 12 (0.9) 181 (n.s.) 589.0 13 0.022
<60 532 11 (2.1) 57 (33–207) 225.0 16 0.071
Unknown 892 15 (1.7) 74 (44–227) 382.1 24 0.063
PPG (mg/dL) <140 45 1 (2.2) < 0.01 57 (n.s.) 19.1 1 0.052
140≤, <180 132 5 (3.8) 30 (15–4008) 57.2 8 0.140
180≤, <220 235 3 (1.3) 125 (n.s.) 103.5 7 0.068
≥220 1043 5 (0.5) Reference 446.7 13 0.029
  1. Note: Since the incidence of hypoglycemia was very low in insulin non-naïve group patients (3 patients having 6 episodes of hypoglycemia), we have not reported the univariate analysis of that data.
  2. Insulin-naïve group: patients having been treated with OADs (n = 3732).
  3. Insulin non-naïve group: patients treated with OADs + insulin other than insulin glargine, and switching to OADs + insulin glargine (n = 487).
  4. Each of the subgroups were compared to 'Reference’ subgroup by all characteristics.
  5. Abbreviations: CI confidence interval, eGFR estimated glomerular filtration rate, PPG post-prandial glucose, n.s not significant.
  6. *These were not estimated because incidence rates were below that of the reference category.