Table 2.
Summary of randomized, controlled trials of extended-release exenatide (ExER) compared with metformin, pioglitazone, sitagliptin, insulin glargine, or liraglutide
| Study | Duration of the study (weeks) | Number of patients | Mean duration of diabetes (years) | Exenatide-based therapy | Comparator | Baseline HbA 1c (%) ± SD/SE | Change in HbA 1c (%) from baseline | P value (between-group difference) | Difference in body weight from baseline (kg) | P value (between-group difference) |
|---|---|---|---|---|---|---|---|---|---|---|
| DURATION 1 study [33] | 30 | 259 | 7 | ExER (2 mg once weekly) | ExBID (10 μg twice daily) | 8.3 ± 1.0 | –1.5 (ExBID) | 0.0023 | Similar | 0.89 |
| –1.9 (ExER) | ||||||||||
| DURATION 2 study [34] | 26 | 491 | 6 | ExER (2 mg once weekly) + placebo (oral once daily) | Sitagliptin (100 mg daily) or pioglitazone (45 mg daily) + placebo injection (once weekly) | 8.5 ± 1.1 | –1.5 (ExER) | –2.3 (ExER) | ||
| –0.9 (sitagliptin) | <0.0001 | –0.8 (sitagliptin) | 0.0002 (sitagliptin) | |||||||
| –1.2 (pioglitazone) | 0.0165 | +2.8 (pioglitazone) | <0.0001 (pioglitazone) | |||||||
| DURATION 3 study [35] | 26 | 456 | 8 | ExER (2 mg once weekly) + metformin ± SU | Glargine (once daily) + metformin ± SU | 8.3 ± 1.1 | –1.5 (ExER) | 0.017 | –2.6 (ExER) | <0.0001 |
| –1.3 (glargine) | +1.4 (glargine) | |||||||||
| DURATION 4 study [36] | 26 | 820 | 2.7 | ExER (2 mg once weekly) + placebo (oral once daily) | Metformin (2,500 mg) + placebo (SC once weekly) | 8.5 | –1.53 (ExER) | –2.0 (ExER) | ||
| –1.48 (metformin) | 0.62 | –2.01 (metformin) | 0.89 | |||||||
| Pioglitazone (45 mg) + placebo (SC once weekly) | –1.63 (pioglitazone) | 0.33 | +1.5 (pioglitazone) | < 0.001 | ||||||
| Sitagliptin (100 mg) + placebo (SC once weekly) | –1.15 (sitagliptin) | <0.001 | –0.8 (sitagliptin) | <0.001 | ||||||
| DURATION 5 study [37] | 24 | 252 | 7 | ExER (2 mg once weekly) + metformin ± SU ± TZD | ExBID (10 μg twice daily) + metformin ± SU ± TZD | 8.4 ± 1.2 | –1.6 (ExER) | <0.0001 | –2.3 (ExER) | 0.01 |
| –0.9 (ExBID) | –1.4 (ExBID) | |||||||||
| DURATION 6 study [38] | 26 | 912 | NS | ExER (2 mg once weekly) + metformin ± SU ± pioglitazone | Liraglutide (1.8 mg once weekly) + metformin ± SU ± pioglitazone | 8.5 ± 1.0 | –1.28 (ExER) | NS | –2.68 (ExER) | NS |
| –1.48 (liraglutide) | –3.58 (liraglutide) |
ExBID exenatide twice daily, ExER exenatide extended release, HbA 1c hemoglobin A1c, NS not stated, SC subcutaneously, SU sulfonylurea, TZD thiazolidinedione