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%)