Table 4.
Percent of ≥1 confirmed hypoglycemic (≤70 mg/dL) or severe hypoglycemia events in T1DM and T2DM patients
| Trial | Na | Background regimen | Pre-specified time periods | Comparators | Nocturnal hypoglycemia (24 h)
|
Hypoglycemic at any time of day (24 h)
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % Participants
|
Annualized rate
|
% Participants
|
Annualized rate
|
||||||||||||
| ≤70 mg/dLb | Relative risk vs Gla-100 (95% CI) | p-Value | Events/patient-yearb | Rate ratio (95% CI) | p-Value | ≤70 mg/dL | Relative risk vs Gla-100 (95% CI) | Events/patient yearb | Rate ratio (95% CI) | p-Value | |||||
| T1DM | |||||||||||||||
| EDITION 439 6 month |
549 | Basal + mealtime insulin | Baseline to month 6 | Gla-300 | 69 | 0.98 (0.88–1.09) | NS | 8.0 | 0.90 (0.71–1.14) | NS | 93 | 1.00 (0.95–1.04) | 78 | 1.09 (0.94–1.25) | NS |
| Gla-100 | 70 | 9.0 | 94 | 73 | |||||||||||
| Week 9 to month 6 | Gla-300 | 59 | 1.06 (0.92–1.23) | NS | 1.04 (0.80–1.36) | NS | 82 | 0.98 (0.91–1.06) | 1.16 (0.98–1.37) | NS | |||||
| Gla-100 | 56 | 84 | |||||||||||||
| EDITION JP 140 6 month |
243 | Basal + mealtime insulin | Baseline to month 6 | Gla-300 | 69 | 0.85 (0.73–0.99) | NR | 7.5 | 0.66 (0.48–0.92) | NR | 97 | 0.99 (0.95–1.04) | 75.3 | 0.80 (0.65–0.98) | NR |
| Gla-100 | 81 | 11.2 | 98 | 94.8 | |||||||||||
| Week 9 to month 6 | Gla-300 | 62 | 0.84 (0.70–1.00) | NS | 7.5 | 0.71 (0.49 –1.01) | NR | 94 | 1.01 (0.95–1.08) | 71.9 | 0.86 (0.69–1.07) | NR | |||
| Gla-100 | 74 | 10.5 | 93 | 83.6 | |||||||||||
| EDITION JP 144 12 month |
228 | Basal + mealtime insulin | Baseline to month 12 | Gla-300 | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Gla-100 | NR | NR | NR | NR | |||||||||||
| T2DM | |||||||||||||||
| EDITION 130 6 month |
807 | Basal + mealtime insulin | Baseline to month 6 | Gla-300 | 45 | 0.78 (0.68–0.89) | NR | 3.1 | 0.75 (0.58–0.95) | NR | 82 | 0.93 (0.88–0.99) | 25.5 | 0.95 (0.80–1.13) | NR |
| Gla-100 | 58 | 4.2 | 88 | 26.8 | NR | ||||||||||
| Week 9 to month 6 | Gla-300 | 36 | 0.79 (0.67–0.93) | p=0.004 | 3.0 | 0.73 (0.55–0.98) | NR | 75 | 0.96 (0.89–1.04) | 24.4 | 0.99 (0.82–1.19) | NR | |||
| Gla-100 | 46 | 4.0 | 78 | 24.7 | NR | ||||||||||
| EDITION 141 12 month |
806 | Basal + mealtime insulin | Baseline to month 12 | Gla-300 | 55 | 0.84 (0.75–0.94) | NR | 2.9 | 0.90 (0.70–1.16) | NR | 86 | 0.94 (0.89–0.99) | 22.3 | 1.06 (0.89–1.27) | NR |
| Gla-100 | 65 | 3.2 | 92 | 21.0 | NR | ||||||||||
| EDITION 237 6 month |
811 | Basal + OAD | Baseline to month 6 | Gla-300 | 28 | 0.71 (0.58–0.86) | NR | 1.9 | 0.52 (0.35–0.77) | p=0.001 | 70 | 0.90 (0.83–0.98) | 14.0 | NR | NR |
| Gla-100 | 40 | 3.7 | 77 | 18.1 | NR | ||||||||||
| Week 9 to month 6 | Gla-300 | 22 | 0.77 (0.60–0.97) | p=0.038 | 1.9 | NR | NR | 59 | 0.91 (0.82–1.02) | 13.6 | NR | NR | |||
| Gla-100 | 28 | 3.2 | 65 | 16.2 | NR | ||||||||||
| EDITION 242 12 month |
811 | Basal + OAD | Baseline to month 12 | Gla-300 | 38 | 0.84 (0.71–0.99) | NR | 1.7 | 0.63 (0.42–0.96) | NR | 78 | 0.96 (0.89–1.02) | 11.6 | 0.88 (0.71–1.09) | NR |
| Gla-100 | 45 | 2.8 | 82 | 13.2 | NR | ||||||||||
| EDITION 338 6 month |
878 | Insulin naïve | Baseline to month 6 | Gla-300 | 18 | 0.76 (0.59–0.99) | NR | 1.3 | 0.98 (0.64–1.48) | NR | 46 | 0.88 (0.77–1.01) | 6.4 | 0.75 (0.57–0.99) | NR |
| Gla-100 | 24 | 1.3 | 53 | 8.5 | NR | ||||||||||
| Week 9 to month 6 | Gla-300 | 15 | 0.90 (0.67–1.22) | NR | 1.6 | 1.08 (0.66–1.77) | NR | 40 | 0.86 (0.74–1.00) | 7.3 | 0.81 (0.60–1.10) | NR | |||
| Gla-100 | 17 | 1.4 | 46 | 9.0 | NR | ||||||||||
| EDITION JP224 6 month |
241 | Basal + OAD | Baseline to month 6 | Gla-300 | 28 | 0.62 (0.44–0.88) | NR | 2.2 | 0.45 (0.21–0.96) | p=0.040 | 65 | 0.86 (0.73–1.01) | 10.5 | 0.64 (0.43–0.96) | NR |
| Gla-100 | 46 | 5.0 | 77 | 16.5 | NR | ||||||||||
| Week 9 to month 6 | Gla-300 | 25 | 0.58 (0.40–0.85) | NR | 2.2 | 0.37 (0.16–0.83) | NR | 60 | 0.84 (0.70–1.01) | 11.2 | 0.67 (0.43–1.04) | NR | |||
| Gla-100 | 44 | 6.0 | 72 | 16.9 | NR | ||||||||||
| EDITION JP243 12 month |
222 | Basal + OAD | Baseline to month 12 | Gla-300 | 38 | 0.73 (0.55–0.97) | NR | 2.1 | 0.41 (0.18–0.92) | NR | NR | NR | NR | NR | NR |
| Gla-100 | 53 | 5.3 | NR | NR | NR | ||||||||||
| Ritzel et al45 6 month |
2,496 | EDITION 1, 2, 3 | Baseline to month 6 | Gla-300 | NR | 0.75 (0.68–0.83) | NR | 2.1 | 0.69 (0.57–0.84) | p=0.0002 | NR | 0.91 (0.87–0.96) | 15.2 | 0.86 (0.77–0.97) | p=0.0116 |
| Gla-100 | NR | 3.1 | NR | 17.7 | |||||||||||
| Week 9 to month 6 | Gla-300 | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | |||
| Gla-100 | NR | NR | NR | NR | |||||||||||
| Ritzel et al46 12 month |
2,496 | EDITION 1, 2, 3 trials | Baseline to month 12 | Gla-300 | NR | 0.85 (0.77–0.92) | NR | NR | 0.82 (0.67–0.99) | NR | NR | 0.94 (0.90–0.98) | NR | 0.97 (0.87–1.09) | NR |
| Gla-100 | NR | NR | NR | NR | |||||||||||
Notes:
a
Safety population Gla-100;
b
data have been rounded; Bold text represents statistically significant vs Gla-100.
Abbreviations: T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; Gla-100, insulin glargine 100 U/mL; Gla-300, insulin glargine 300 U/mL; NR, not reported; NS, not significant; CI, confidence interval; OAD, oral antidiabetic drugs; RR, relative risk (% participants) and rates ratio (events/patient-year); h, hours.