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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.