Table 1.
Baseline characteristics for patients included in analyses of time in hypoglycemia, mean glucose, and HbA1c
| Demographics and baseline characteristics | All patients (n = 137) |
|---|---|
| Age, years, mean ± SD | 44.6 ± 12.9 |
| Median (range) | 44 (19–77) |
| Sex | |
| Male | 78 (56.9) |
| Female | 59 (43.1) |
| Race | |
| Black | 1 (0.7) |
| White (Caucasian, including Middle East and North Africa) | 136 (99.3) |
| Ethnicity: not Hispanic or Latino | 137 (100.0) |
| Years from diabetes onset to inclusion, mean ± SD | 22.3 ± 11.8 |
| Median (range) | 21.7 (1.4–56.6) |
| Smoking | |
| Current | 17 (12.4) |
| Previous | 31 (22.6) |
| Never | 89 (65.0) |
| Medical history | |
| Previous laser photocoagulation of the retina | 27 (19.7) |
| Previous myocardial infarction | 3 (2.2) |
| Previous stroke | 2 (1.5) |
| Previous bypass graft | 1 (0.7) |
| Previous PCI | 2 (1.5) |
| Previous amputation | 1 (0.7) |
| Previous diabetic foot (or leg) ulcer | 6 (4.4) |
| Current diabetic foot (or leg) ulcer | 3 (2.2) |
| Number of hypoglycemias per week in last 2 months,* mean ± SD | 2.18 ± 1.91 |
| Median (range) | 2 (0–12) |
| Number of patients | 130 |
| Number of severe hypoglycemias past year, mean ± SD | 0.074 ± 0.358 |
| Median (range) | 0 (0–3) |
| Number of patients | 136 |
| Number of severe hypoglycemias past 5 years, mean ± SD | 0.618 ± 2.235 |
| Median (range) | 0 (0–20) |
| Number of patients | 136 |
| HbA1c at visit 2 and randomization | |
| HbA1c at visit 2 (IFCC, mmol/mol), mean ± SD | 71.5 ± 9.3 |
| Median (range) | 70 (58–104) |
| HbA1c at visit 2 (NGSP, %), mean ± SD | 8.70 ± 0.85 |
| Median (range) | 8.56 (7.46–11.67) |
| HbA1c at visit 4 randomization (IFCC, mmol/mol), mean ± SD | 68.9 ± 9.5 |
| Median (range) | 67 (50–103) |
| Number of patients | 136 |
| HbA1c at visit 4 randomization (NGSP, %), mean ± SD | 8.46 ± 0.87 |
| Median (range) | 8.28 (6.73–11.58) |
| Number of patients | 136 |
| Diabetes medication at randomization visit | |
| Base insulin type | |
| Insulatard (NPH insulin) | 3 (2.2) |
| Glargine | 110 (80.3) |
| Detemir | 17 (12.4) |
| Degludec | 7 (5.1) |
| Meal insulin type | |
| Lispro | 52 (38.0) |
| Aspart | 76 (55.5) |
| Glulisine | 7 (5.1) |
| Insulin regular human | 2 (1.5) |
| Total daily meal insulin dose (units), mean ± SD | 27.6 ± 13.5 |
| Median (range) | 25 (0–80) |
| Total daily base insulin dose (units), mean ± SD | 30.5 ± 13.9 |
| Median (range) | 26 (8–90) |
| Total daily insulin dose (units), mean ± SD | 58.1 ± 23.5 |
| Median (range) | 55 (21–138) |
| Number of insulin injections, mean ± SD | 4.82 ± 0.97 |
| Median (range) | 5 (1–8) |
| Metformin used at randomization visit | 2 (1.5) |
Data are n (%) unless otherwise indicated. IFCC, the International Federation of Clinical Chemistry and Laboratory Medicine; NGSP, the National Glycohemoglobin Standardization Program; PCI, percutaneous coronary intervention.
*
Hypoglycemias experienced per week in last 2 months based on subjective estimation, not blood glucose values.