TABLE 1.
Characteristics, Efficacy, and Safety Endpoints of the EDITION Trials
| Study(Ref.) | Population | n | Characteristics, Mean | Confirmed or Severe Hypoglycemia:† |
Severe Hypoglycemia:† Baseline to Month 6 | ||||||||||
| A1C Change:* Baseline to Month 6 |
Nocturnal Baseline to Week 8 |
Nocturnal Week 9 to Month 8 | Nocturnal Baseline to Month 6 |
Any Time of Day Baseline to Month 6 |
|||||||||||
| Gla-300 | Gla-100 | Gla-300 | Gla-100 | Gla-300 | Gla-100 | Gla-300 | Gla-100 | Gla-300 | Gla-100 | Gla-300 | Gla-100 | ||||
| Type 2 Diabetes | |||||||||||||||
| EDITION 1 (22) | Basal + mealtime insulin | 807 | Diabetes duration: 16 years | −0.83% | −0.83% | 26.2% | 33.3% | 36.1% | 46.0% | 44.6% | 57.5% | 81.9% | 87.8% | 5.0% | 5.7% |
| BMI: 36.6 kg/m2 | LS mean difference: −0.00% (95% CI −0.11 to 0.11) | RR 0.79 (95% CI 0.64–0.98) | RR 0.79 (95% CI 0.67–0.93) | RR 0.78 (95% CI 0.68–0.89) | RR 0.93 (95% CI 0.88–0.99) | RR 0.80 (95% CI 0.48–1.55) | |||||||||
| A1C: 8.2% | |||||||||||||||
| EDITION 2 (23) | Basal insulin + OADs | 811 | Diabetes duration: 13 years | −0.57% | −0.56% | 13.2% | 24.6% | 21.6% | 27.9% | 28.3% | 39.9% | 70.0% | 77.3% | 1.0% | 1.5% |
| BMI: 34.8 kg/m2 | LS mean difference: −0.01% (95% CI −0.14 to 0.12) | RR 0.53 (95% CI 0.39–0.72) | RR 0.77 (95% CI 0.60–0.97) | RR 0.71 (95% CI 0.58–0.86) | RR 0.90 (95% CI 0.83–0.98) | NA | |||||||||
| A1C: 8.2% | |||||||||||||||
| EDITION 3 (24) | Insulin naive | 878 | Diabetes duration: 10 years | −1.42% | −1.46% | 7.4% | 1.0% | 15.4% | 17.1% | 17.9% | 23.5% | 46.2% | 52.5% | 0.9% | 0.9% |
| BMI: 33.0 kg/m2 | LS mean difference: 0.04% (95% CI −0.09 to 0.17) | RR 0.74 (95% CI 0.48–1.13) | RR 0.89 (95% CI 0.66–1.20) | RR 0.76 (95% CI 0.59–0.99) | RR 0.88 (95% CI 0.77–1.01) | NA | |||||||||
| A1C: 8.5% | |||||||||||||||
| EDITION JP 2 (25) | Japanese study; basal insulin + OADs | 241 | Diabetes duration: 14 years | −0.45% | −0.55% | 13.3% | 16.7% | 25.4% | 43.7% | 28.3% | 45.8% | 65.0% | 76.7% | Infrequent | Infrequent |
| BMI: 25.3 kg/m2 | LS mean difference: 0.10% (95% CI −0.08 to 0.27) | RR 0.83 (95% CI 0.45–1.52) | RR 0.58 (95% CI 0.40–0.85) | RR 0.62 (95% CI 0.44–0.88) | RR 0.86 (95% CI 0.73–1.01) | NA | |||||||||
| A1C: 8.0% | |||||||||||||||
| Type 1 Diabetes | |||||||||||||||
| EDITION 4 (26) | Basal + mealtime insulin | 549 | Diabetes duration: 21 years | −0.40% | −0.44% | NA | NA | NA | NA | NA | NA | NA | NA | 6.6% | 9.5% |
| BMI: 27.6 kg/m2 | LS mean difference: 0.04% (95% CI −0.10 to 0.19) | NA | NA | NA | NA | NA | |||||||||
| A1C: 8.1% | |||||||||||||||
| EDITION JP 1 (27) | Japanese study; basal + mealtime insulin | 243 | Diabetes duration: 13 years | −0.30% | −0.43% | 43.4% | 61.2% | 61.7% | 73.7% | −0.00% | −0.00% | −0.00% | −0.00% | Infrequent | Infrequent |
| A1C: 8.1% | LS mean difference: 0.13% (95% CI −0.03 to 0.29) | RR 0.71 (95% CI 0.56–0.91) | RR 0.84 (95% CI 0.70–1.00) | LS mean difference: −0.00% (95% CI −0 to 0 | LS mean difference: −0.00% (95% CI −0 to 0 | NA | |||||||||
*
LS mean change.
†
People experiencing ≥1 hypoglycemic event (safety population). NA, not available; OADs, oral antidiabetes drugs.