Table 1.
Patient disposition
| Monotherapy | Sulfonylurea | Glinide | α-GI | Biguanide | TZD | DPP-4 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100 mg | 200 mg | 100 mg | 200 mg | 100 mg | 200 mg | 100 mg | 200 mg | 100 mg | 200 mg | 100 mg | 200 mg | 100 mg | 200 mg | |
| Patients randomized | 127 | 253 | 124 | 125 | 65 | 64 | 62 | 61 | 72 | 76 | 63 | 62 | 71 | 74 |
| Patients who discontinued | 11 | 26 | 15 | 14 | 5 | 8 | 4 | 5 | 7 | 7 | 5 | 5 | 5 | 9 |
| Reasons for discontinuation† | ||||||||||||||
| Patient request | 6 | 15 | 10 | 1 | 2 | 3 | 1 | 0 | 2 | 3 | 3 | 4 | 3 | 5 |
| Ineligible for the study | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse event | 5 | 10 | 2 | 8 | 2 | 4 | 3 | 3 | 5 | 3 | 1 | 1 | 2 | 1 |
| Worsening of diabetes | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Other reason‡ | 0 | 1 | 2 | 3 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 3 |
| Completed treatment | 116 | 227 | 109 | 111 | 60 | 56 | 58 | 56 | 65 | 69 | 58 | 57 | 66 | 65 |
| Full analysis set | 127 | 252 | 124 | 125 | 65 | 64 | 62 | 60 | 72 | 76 | 63 | 62 | 71 | 74 |
| Safety analysis set | 127 | 253 | 124 | 125 | 65 | 64 | 62 | 61 | 72 | 76 | 63 | 62 | 71 | 74 |
Values are the number of patients.
†
During the treatment period.
‡
None of the patient withdrawals were as a result of the fasting plasma glucose level exceeding 270 mg/dL or the investigator deeming the participant should discontinue the combination drug. α-GI, α-glucosidase inhibitor; DPP-4, dipeptidyl peptidase-4 inhibitor; TZD, thiazolidinedione.