Parameter | PDM011011 capsules (N = 83) | Metformin (N = 40) |
Subjects dosed | 83 (100.00%) | 40 (100.00%) |
Intent to treat population | 80 (96.39%) | 39 (97.50%) |
Per protocol population | 73 (87.95%) | 35 (87.50%) |
Subjects excluded from PP population with compliance < 80% | 2 (2.40%) | 1 (2.50%) |
Study completed |
|
|
Yes | 75 (90.36%) | 36 (90.00%) |
No | 8 (9.64%) | 4 (10.00%) |
Reason for study termination |
|
|
Prematurely discontinued | 8 (9.64%) | 4 (10.00%) |
Safety reason as judged by the investigator and/or Sponsor | 2 (25.00%) | 0 |
Withdrawal of consent | 5 (62.50%) | 0 |
Lost to follow-up | 1 (12.50%) | 3 (7.50%) |
Other, specify* | 0 | 1 (2.50%) |
on PI discretion** | 0 | 1 (2.50%) |