Table 4.

Phase 3 HARMONY Trials with Albiglutide39–46

Trial	Study drug	Albiglutide outcomes vs comparator drugs
HARMONY-1	Albiglutide 30 mg vs placebo	HbA1c: −0.8% vs −0.1% Hyperglycemia events: 24.4% vs 47.7% No significant differences in weight change All GI events: 31.3% vs 29.8% Diarrhea: 11.3% vs 8.0% Nausea: 10.7% vs 11.3% Vomiting: 4% vs 4%
HARMONY-2	Albiglutide 30 mg vs albiglutide 50 mg vs placebo	HbA1c: −0.84% vs −1.04% No significant changes in weight w/ 2 albiglutide doses Similar nausea, diarrhea, vomiting, hypoglycemia rate in all groups, including placebo
HARMONY-3	Albiglutide 30 mg vs sitagliptin 100 mg vs glimepiride 2 mg vs placebo; all concurrently taking metformin	HbA1c: −0.9% vs −0.4% vs −0.3% (vs placebo) Weight change: −1.21 kg vs −0.86 kg vs +1.17 kg vs −1.0 kg Hyperglycemia rates: 25.8% vs 36.4% vs 32.7% vs 59.2% Diarrhea: 12.9% vs 8.6% vs 10.9% (vs placebo) Nausea: 10.3% vs 6.2% vs 10.9% (vs placebo)
HARMONY-4	Albiglutide vs insulin glargine titrated to fasting plasma glucose goal of 100 mg/dL	HbA1c: −0.7% vs −0.8% Weight change: −1.0 kg vs +1.5 kg Hypoglycemia: 17.5% vs 27.4%
HARMONY-5	Albiglutide 30 mg titrated up to 50 mg vs pioglitazone 30 mg titrated up to 50 mg; all concurrently taking metformin ± glimepiride 4 mg	HbA1c reduction: −0.87% vs placebo HbA1c +0.25 vs pioglitazone: not meeting noninferiority criteria Hypoglycemia: 14% vs 25% vs 14% Weight change: −0.42 kg vs +4.4 kg vs −0.4 kg
HARMONY-6	Albiglutide 30 mg titrated up to 50 mg vs insulin lispro 3 × daily adjusted per glucose level	HbA1c: −0.82% vs −0.66% Weight change: −7.3 kg vs +0.81 kg Severe hypoglycemia: 0 vs 2 events Nausea: 11.2% vs 1.4% Vomiting: 6.7% vs 1.4% Injection-site reaction: 9.5% vs 5.3%
HARMONY-7	Albiglutide 30 mg titrated up to 50 mg vs liraglutide 0.6 mg titrated up to 1.8 mg; all concurrently taking metformin ± sulfonylurea ± thiazolidinedione	HbA1c: −0.78% vs −0.99% Injection-site reaction: 12.9% vs 5.4% GI adverse effects: 35.9% vs 49%
HARMONY-8	Albiglutide vs sitagliptin with GFR >60 mL/min, GFR 30–59 mL/min, GFR 15–29 mL/min; all ± oral diabetes drugs	HbA1c: −0.83% vs −0.52% Time to hyperglycemic rescue longer w/ albiglutide All adverse events: 51.7% vs 25.2% Diarrhea: 10% vs 6.5% Nausea: 4.8% vs 3.3% Vomiting: 1.6% vs 1.2% Hypoglycemia: 24.1% vs 15.9% (sulfonylurea: 22.5% vs 14.2%; no sulfonylurea: 4% vs 4%) Weight change: −0.79 kg vs −0.19 kg

GFR indicates glomerular filtration rate; GI, gastrointestinal; HbA_1c, glycated hemoglobin.