TABLE 1.

Characteristics, Efficacy, and Safety Endpoints of the EDITION Trials

Study(Ref.)PopulationnCharacteristics, MeanConfirmed or Severe Hypoglycemia:Severe Hypoglycemia: Baseline to Month 6
A1C Change:* Baseline to Month 6Nocturnal Baseline to Week 8Nocturnal Week 9 to Month 8Nocturnal Baseline to Month 6Any Time of Day Baseline to Month 6
Gla-300Gla-100Gla-300Gla-100Gla-300Gla-100Gla-300Gla-100Gla-300Gla-100Gla-300Gla-100
Type 2 Diabetes
EDITION 1 (22)Basal + mealtime insulin807Diabetes 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/m2LS 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 + OADs811Diabetes 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/m2LS 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 naive878Diabetes 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/m2LS 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 + OADs241Diabetes duration: 14 years−0.45%−0.55%13.3%16.7%25.4%43.7%28.3%45.8%65.0%76.7%InfrequentInfrequent
BMI: 25.3 kg/m2LS 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 insulin549Diabetes duration: 21 years−0.40%−0.44%NANANANANANANANA6.6%9.5%
BMI: 27.6 kg/m2LS mean difference: 0.04% (95% CI −0.10 to 0.19)NANANANANA
A1C: 8.1%
EDITION JP 1 (27)Japanese study; basal + mealtime insulin243Diabetes duration: 13 years−0.30%−0.43%43.4%61.2%61.7%73.7%−0.00%−0.00%−0.00%−0.00%InfrequentInfrequent
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 0LS mean difference: −0.00% (95% CI −0 to 0NA
  • * LS mean change.

  • People experiencing ≥1 hypoglycemic event (safety population). NA, not available; OADs, oral antidiabetes drugs.