Table 2.
Adverse events, serious adverse events, and hypoglycemia in saxagliptin 24-week phase 3 clinical trials
| Study ID | Study design | Treatment (mg/day) | Patients (%) | |||||
|---|---|---|---|---|---|---|---|---|
| ≥1 AE | ≥1 SAE | Discontinuation due to | Hypoglycemia | |||||
| AE | SAE | Reported | Confirmed | |||||
| NCT00121641 [19] | SAXA vs PBO in treatment-naïve patients | PBO | 71.6 | 3.2 | 0 | 0 | 6.3 | 0 |
| SAXA 2.5 | 74.5 | 2.9 | 3.9 | 2.0 | 2.9 | 0 | ||
| SAXA 5 | 75.5 | 5.7 | 2.8 | 0 | 4.7 | 0 | ||
| NCT00316082 [16] | SAXA vs PBO in treatment-naïve patients | PBO | 55.4 | 6.8 | 4.1 | 2.7 | 4.1 | 1.4 |
| SAXA 2.5 | 66.2 | 9.5 | 5.4 | 1.4 | 4.1 | 0 | ||
| SAXA 5 | 73.0 | 10.8 | 2.7 | 0 | 8.1 | 1.4 | ||
| NCT00698932 [18] | SAXA vs PBO in treatment-naïve patients | PBO | 35.9 | 1.4 | 0.7 | 0.4 | 0.7 | 0 |
| SAXA 5 | 43.7 | 2.8 | 1.1 | 0 | 1.8 | 0 | ||
| NCT00918879 [17] | SAXA vs PBO in treatment-naïve Indian patients | PBO | 45.3 | 0 | 0 | – | 0 | 0 |
| SAXA 5 | 47.7 | 0 | 0 | – | 0 | 0 | ||
| NCT00121667 [21] | SAXA add-on to MET vs PBO add-on to MET | PBO | 64.8 | 2.8 | 1.1 | – | 5.0 | 0.6 |
| SAXA 2.5 | 79.7 | 2.6 | 2.6 | – | 7.8 | 0.5 | ||
| SAXA 5 | 70.2 | 4.2 | 3.1 | – | 5.2 | 0.5 | ||
| NCT00661362 [23] | SAXA add-on to MET vs PBO add-on to MET in Asian patients | PBO | 41.5 | 1.0 | 1.0 | 0.3 | 1.4 | 0 |
| SAXA 5 | 43.8 | 2.8 | 2.1 | 0.7 | 1.4 | 0 | ||
| NCT00327015 [24] | SAXA add-on to MET vs PBO add-on to MET as initial therapy in treatment-naïve patients | PBO | 58.5 | 2.4 | 3.4 | 0.3 | 4.0 | 0.3 |
| SAXA 5 | 55.3 | 2.5 | 2.5 | 0.3 | 3.4 | 0 | ||
| NCT01006590 [22] | SAXA add-on to MET vs PBO + MET uptitration | PBO | 43.9 | 4.3 | 3.6 | – | 2.2 | 1.4 |
| SAXA 5 | 51.0 | 4.1 | 2.7 | – | 6.8 | 1.4 | ||
| NCT00295633 [25] | SAXA add-on to TZD vs PBO add-on to TZD | PBO | 66.8 | 5.4 | 3.3 | 1.6 | 3.8 | 0 |
| SAXA 2.5 | 62.1 | 4.1 | 1.5 | 0 | 4.1 | 0.5 | ||
| SAXA 5 | 74.2 | 3.8 | 5.9 | 0.5 | 2.7 | 0 | ||
| NCT00757588 [27] | SAXA add-on to INS ± MET vs PBO add-on to INS ± MET | PBO | 59.6 | 4.0 | 2.0 | 0 | 19.9 | 3.3 |
| SAXA 5 | 56.9 | 3.9 | 1.3 | 0 | 18.4 | 5.3 | ||
| NCT00313313 [26] | SAXA add-on to GLY vs PBO add-on to GLY | PBO | 76.8 | 2.2 | 1.5 | 0.4 | 10.1 | 0.7 |
| SAXA 2.5 | 75.0 | 1.6 | 1.2 | 0 | 13.3 | 2.4 | ||
| SAXA 5 | 72.3 | 2.4 | 3.2 | 0.4 | 14.6 | 0.8 | ||
| NCT00575588 [29] | SAXA add-on to MET vs GLIP add-on to METa | GLIP ≥20 | 68.1 | 7.4 | 4.4 | 1.9 | 36.3 | 8.8 |
| SAXA 5 | 60.7 | 9.1 | 4.2 | 1.9 | 3.0 | 0 | ||
| NCT01128153 [28] | SAXA add-on to MET + SU vs PBO add-on to MET + SU | PBO | 71.7 | 5.5 | 2.3 | 0.8 | 6.3 | 0 |
| SAXA 5 | 62.8 | 2.3 | 0.8 | 0 | 10.1 | 1.6 | ||
| NCT01606007 [30] | SAXA + DAPA add-on to MET | SAXA 5 + DAPA 10 | 49 | 1 | 0.6 | 0 | 1 | 0b |
| vs SAXA + PBO add-on to MET | SAXA 5 | 53 | 3 | 0 | 0 | 1 | 0b | |
| vs DAPA + PBO add-on to MET | DAPA 10 | 49 | 1 | 0.6 | 0 | 1 | 0b | |
AE adverse event, DAPA dapagliflozin, GLIP glipizide, GLY glyburide, INS insulin, MET metformin, PBO placebo, SAE serious adverse event, SAXA saxagliptin, SU sulfonylurea, TZD thiazolidinedione
aTrial was 52 weeks in duration
bMajor hypoglycemic event defined as symptomatic requiring third-party assistance due to severe impairment in consciousness or behavior with plasma glucose concentration <54 mg/dL and prompt recovery after glucose or glucagon administration