Table 2.
Endpoints Pre- and Postamendment of the Trial Protocol.
| Preamendment | Postamendment |
|---|---|
| Primary endpoint • Number of severe or BG-confirmed symptomatic hypoglycemic episodes during the maintenance period |
Primary endpoint • Number of severe or BG-confirmed symptomatic hypoglycemic episodes during maintenance period 2 |
| Secondary confirmatory endpoints • Basal insulin dose (U) at end of maintenance period • Number of nocturnal, severe or BG-confirmed symptomatic hypoglycemic episodes during maintenance period • Number of severe or BG-confirmed symptomatic hypoglycemic episodes from randomization to end of maintenance period • Number of severe hypoglycemic episodes during maintenance period |
Secondary confirmatory endpoints • Basal insulin dose (U) at end of maintenance period 2 • Number of nocturnal, severe or BG-confirmed symptomatic hypoglycemic episodes during maintenance period 2 • Number of severe hypoglycemic episodes during maintenance period 2 |
| Key secondary endpoints • Change from baseline to end of maintenance period in HbA1c, FPG, SMBG, and body weight • Number of nocturnal, severe or BG- confirmed symptomatic hypoglycemic episodes from randomization until end of maintenance period • Number of severe hypoglycemic episodes from randomization until end of maintenance period • Number of adverse events from randomization to end of maintenance period |
Key secondary endpoints • Change from baseline to end of maintenance period 2 in HbA1c, FPG, SMBG, and body weight • Number of severe or BG-confirmed symptomatic hypoglycemic episodes from randomization to end of maintenance period 2 • Number of nocturnal, severe or BG-confirmed symptomatic hypoglycemic episodes from randomization until end of maintenance period 2 • Number of severe hypoglycemic episodes from randomization until end of maintenance period 2 • Number of adverse events from randomization to end of maintenance period 2 |
| Durations • Maintenance period: 36 weeks • Randomization to end of maintenance period: 52 weeks |
Durations • Maintenance period 2: 36 weeks • Randomization to end of maintenance period 2: up to 88 weeks |
Nocturnal episodes of severe hypoglycemia were defined as those occurring between 00:01 and 05:59, both inclusive.