Table 1.
Design, Efficacy, and Select Adverse Events for Published DURATION Studies
| DURATION-1 | DURATION-2 | DURATION-3 | DURATION-5 | |
|---|---|---|---|---|
| Design | OL | DBDD | OL | OL |
| Duration (weeks) | 30 | 26 | 26 | 24 |
| Background therapy | D/E alone or with Met, SU, or TZD (or combinations) | Met | Met±SU | D/E alone or with Met, SU, or TZD (or combinations) |
| EQW | 2 mg QW | 2 mg QW | 2 mg QW | 2 mg QW |
| Comparator(s) | EBID (10 μg BID) | Sit (100 mg QD) | Insulin glargine (10 IU QD)a | EBID (10 μg BID) |
| Pio (45 mg QD) | ||||
| ITT population (n) | 148 | 160 | 233 | 129 |
| Withdrawal (%) | 13.5% | 20.6% | 10.3% | 15.5% |
| HbA1c (%) | ||||
| Baseline | 8.3 | 8.6 | 8.3 | 8.5 |
| LS mean change | −1.9 | −1.5 | −1.5 | −1.6 |
| HbA1c targets (%) | ||||
| <7.0% | 71 | 59 | 60 | 58 |
| ≤6.5% | 45 | 39 | 35 | 41 |
| FPG (mmol/L) | ||||
| Baseline | 9.60 | 9.21 | 9.82 | 9.60 |
| LS mean change | −2.33 | −1.78 | −2.11 | −1.94 |
| Weight (kg) | ||||
| Baseline | 101.7 | 89.9 | 91.2 | 97 |
| LS mean change | −3.7 | −2.3 | −2.6 | −2.3 |
| SBP (mm Hg) | ||||
| Baseline | 127.8 | 126.4 | 135.4 | 130.4 |
| LS mean change | −4.7 | −3.6 | −3.0 | −2.9 |
| Adverse events (%) | ||||
| Nausea | 26.4 | 23.8 | 12.9 | 14.0 |
| Diarrhea | 14.9 | 18.1 | 8.6 | 9.3 |
| Vomiting | 10.8 | 11.3 | 4.3 | 4.7 |
| Constipation | 10.8 | 5.6 | 3.0 | 0.8 |
| Injection site pruritus | 18.2 | 5.0 | 0.9 | 4.7 |
| Injection site erythema | 7.4 | 3.1 | 1.3 | 5.4 |
a
Adjusted to target fasting plasma glucose (FPG) of 4.0–5.5 mmol/L.
BID, twice-daily; DBDD, double-blind double-dummy; D/E, diet and exercise; EBID, exenatide BID; EQW, exenatide once-weekly; HbA1c, hemoglobin A1c; ITT, intent to treat; LS, least square; Met, metformin; OL, open-label; Pio, pioglitazone; QD, once-daily; QW, once-weekly; SBP, systolic blood pressure; Sit, sitagliptin; SU, sulfonylurea; TZD, thiazolidinedione.