Table 5.
| Trial | Study drug | Dulaglutide outcomes vs comparator drugs |
|---|---|---|
| AWARD-1 | Dulaglutide 1.5 mg once weekly vs dulaglutide 0.75 mg vs exenatide 10 μg twice daily; all concurrently taking metformin and pioglitazone (26-week study) | HbA1c: −1.51% vs −1.3% vs −0.99% Body weight: −1.3 kg vs +0.2 kg vs −1.07 kg No severe hypoglycemia w/ dulaglutide Very similar rates of nausea, vomiting, & diarrhea with dulaglutide 1.5 mg & exenatide Less adverse effects w/ dulaglutide 0.75 mg |
| AWARD-2 | Dulaglutide 1.5 mg vs dulaglutide 0.75 mg vs insulin glargine; all concurrently taking metformin and glimepiride (52-week study) | HbA1c: −1.08% vs −0.76% vs −0.63% Superiority met w/ dulaglutide 1.5 & noninferiority w/ 0.75-mg dose Hypoglycemia rates lower w/ dulaglutide More nausea and diarrhea w/ dulaglutide than glargine |
| AWARD-3 | Dulaglutide 1.5 mg vs dulaglutide 0.75 mg vs metformin titrated up to 2000 mg/day (26-week study) | HbA1c: −0.78% vs −0.71% vs −0.51% Dulaglutide 1.5 mg & 0.75 mg met superiority w/ HbA1c reduction Similar decreases in weight between all 3 groups Nausea, diarrhea, & vomiting were similar between dulaglutide & metformin |
| AWARD-4 | Dulaglutide 1.5 mg vs dulaglutide 0.75 mg vs insulin glargine; all concurrently receiving prandial insulin lispro (52-week study) | HbA1c: −1.64% vs −1.59% vs −1.41% Noninferiority of dulaglutide 1.5 mg vs glargine w/ HbA1c reduction Weight change: −2.88 kg vs −2.39 kg vs −1.75 kg; significance difference w/ dulaglutide 1.5 mg vs sitagliptin More nausea, diarrhea, & vomiting w/ dulaglutide than glargine |
| AWARD-5 | Dulaglutide 1.5 mg vs dulaglutide 0.75 mg vs sitagliptin 100 mg; all concurrently taking metformin (52-week study) | HbA1c: −1.10% vs −0.87% vs −0.39% Both doses met superiority to sitagliptin More nausea, diarrhea, & vomiting w/ dulaglutide |
| AWARD-6 | Dulaglutide 1.5 mg vs liraglutide 1.8 mg; all concurrently taking metformin (26-week study) | HbA1c: −1.42% vs −1.36%; met noninferiority criteria Greater weight loss w/ liraglutide (–2.9 kg vs −3.61 kg) Nausea: 20% vs 18% Diarrhea: 12% vs 12% Dyspepsia: 8% vs 6% Vomiting: 7% vs 8% |
| AWARD-8 | Dulaglutide 1.5 mg vs placebo; all concurrently taking glimepiride | HbA1c difference: −1.3%; superior to placebo Fasting plasma glucose difference: −33.54 mg/dL; superior to placebo Weight loss was significant from baseline w/ dulaglutide, but between-groups difference not significant Hypoglycemia higher w/ dulaglutide (2.37 vs 0.07 events/participant annually) No severe hypoglycemic events |
HbA1c indicates glycated hemoglobin.