Table 3.

Phase 3 LEAD Trials with Liraglutide28–33

Trial	Study drug	Liraglutide outcomes vs comparator drugs
LEAD-1	Liraglutide 1.2 mg & 1.8 mg once daily vs rosiglitazone 4 mg once daily; all concurrently taking sulfonylurea	Significant HbA1c reduction w/ liraglutide 1.2 mg & 1.8 mg: 1.1% vs −0.4% w/ rosiglitazone 4 mg Significant decrease in FPG & PPG w/ liraglutide vs rosiglitazone Minor hypoglycemia, <10%; nausea, <11%; vomiting, <5%; diarrhea, <8%
LEAD-2	Liraglutide 1.2 mg & 1.8 mg vs glimepiride 4 mg; all concurrently taking metformin	Noninferior HbA1c reduction in liraglutide groups: mean decrease, −1% Body weight −2.8 kg w/ 1.8-mg liraglutide vs +1.0 kg w/ glimepiride Less hypoglycemic events in liraglutide groups: 3% vs 17% w/ glimepiride Increased nausea in liraglutide groups
LEAD-3	Liraglutide 1.2 mg & 1.8 mg once daily vs glimepiride 8 mg once daily	HbA1c reductions: −0.84% & −1.23% w/ liraglutide 1.2 mg & 1.8 mg vs 0.51% w/ glimepiride 8 mg No major hypoglycemic events Significantly less minor hypoglycemia: 8% & 12% vs 24%
LEAD-4	Liraglutide 1.2 mg & 1.8 mg vs placebo; all concurrently taking metformin and rosiglitazone	HbA1c reduction: −1.5% vs −0.5% Significant FPG and PPG reductions w/ 1.2-mg & 1.8-mg liraglutide Body weight reductions: −1.0 kg & −2.0 kg w/ liraglutide 1.2 mg & 1.8 mg vs +0.6-kg weight gain w/ placebo Systolic BP reductions: −6.7 mm Hg & −5.6 mm Hg w/ liraglutide 1.2 mg & 1.8 mg vs −1.1 mm Hg w/ placebo Minor hypoglycemia: 7.9% & 9% vs 5.1% No major hypoglycemic events
LEAD-5	Liraglutide 1.8 mg vs insulin glargine; all concurrently taking metformin and glimepiride	Significantly greater HbA1c reduction: −1.33% vs −1.09% Significantly greater weight loss w/ liraglutide: −1.39 kg vs +3.43 kg Systolic BP reduction: −4 mm Hg vs +0.5 mm Hg Major & minor hypoglycemia rates: 0.06 & 1.2 vs 0 & 1.3 events/patient annually
LEAD-6	Liraglutide 1.8 mg vs exenatide 10 μg twice daily, all concurrently taking metformin and sulfonylurea	Significant HbA1c reduction: −1.12% vs −0.79% Greater FPG reduction vs exenatide Weight loss: 3.24 kg vs 2.87 kg (difference not significant) Significantly less minor hypoglycemia w/ liraglutide: 25.5% vs 33.6% 2 patients taking exenatide & sulfonylurea had major hypoglycemia Less nausea w/ liraglutide

BP indicates blood pressure; FPG, fasting plasma glucose; HbA_1c, glycated hemoglobin; PPG, postprandial glucose.