The effects of LY2189265, a long-acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study

Umpiérrez, Guillermo E.; Blevins, Thomas; Rosenstock, Julio; Cheng, Christine; Anderson, James H.; Bastyr, Edward J.

doi:10.1111/j.1463-1326.2011.01366.x

Cited by 80 publications

(110 citation statements)

References 26 publications

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“…In this population, patients receiving dulaglutide 1.5 mg achieved a further 1.5% HbA 1c reduction from the baseline mean HbA 1c of 8.1% (65 mmol/mol), with 78% achieving the goal of ,7.0% (53 mmol/mol); both results are superior to exenatide. The previously reported similar glycemic effect of dulaglutide (12) and exenatide (13,14) compared with placebo provides additional support for the current results.…”

Section: Discussionsupporting

confidence: 78%

Efficacy and Safety of Dulaglutide Added Onto Pioglitazone and Metformin Versus Exenatide in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-1)

et al. 2014

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OBJECTIVETo compare the efficacy and safety of dulaglutide, a once-weekly GLP-1 receptor agonist, with placebo and exenatide in type 2 diabetic patients. The primary objective was to determine superiority of dulaglutide 1.5 mg versus placebo in HbA 1c change at 26 weeks. RESEARCH DESIGN AND METHODSThis 52-week, multicenter, parallel-arm study (primary end point: 26 weeks) randomized patients (2:2:2:1) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, exenatide 10 mg, or placebo (placebo-controlled period: 26 weeks). Patients were treated with metformin (1,500-3,000 mg) and pioglitazone (30-45 mg). Mean baseline HbA 1c was 8.1% (65 mmol/mol). RESULTSLeast squares mean 6 SE HbA 1c change from baseline to the primary end point was 21.51 6 0.06% (216.5 6 0.7 mmol/mol) for dulaglutide 1.5 mg, 21.30 6 0.06% (214.2 6 0.7 mmol/mol) for dulaglutide 0.75 mg, 20.99 6 0.06% (210.8 6 0.7 mmol/mol) for exenatide, and 20.46 6 0.08% (25.0 6 0.9 mmol/mol) for placebo. Both dulaglutide doses were superior to placebo at 26 weeks (both adjusted one-sided P < 0.001) and exenatide at 26 and 52 weeks (both adjusted one-sided P < 0.001). Greater percentages of patients reached HbA 1c targets with dulaglutide 1.5 mg and 0.75 mg than with placebo and exenatide (all P < 0.001). At 26 and 52 weeks, total hypoglycemia incidence was lower in patients receiving dulaglutide 1.5 mg than in those receiving exenatide; no dulaglutide-treated patients reported severe hypoglycemia. The most common gastrointestinal adverse events for dulaglutide were nausea, vomiting, and diarrhea. Events were mostly mild to moderate and transient. CONCLUSIONSBoth once-weekly dulaglutide doses demonstrated superior glycemic control versus placebo and exenatide with an acceptable tolerability and safety profile.

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Section: Discussionsupporting

confidence: 78%

Efficacy and Safety of Dulaglutide Added Onto Pioglitazone and Metformin Versus Exenatide in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-1)

et al. 2014

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“…Dulaglutide exhibits GLP-1-mediated effects, including glucose-dependent potentiation of insulin secretion, inhibition of glucagon secretion, delay of gastric emptying, and weight loss. In phase 2 studies, dulaglutide demonstrated significant dose-dependent improvements in glycemic control and body weight and a low rate of hypoglycemia (10,11). The most frequent side effects of dulaglutide in these studies were GI related, as observed with other GLP-1 receptor agonists (10)(11)(12).…”

mentioning

confidence: 89%

Efficacy and Safety of Dulaglutide Monotherapy Versus Metformin in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-3)

Umpiérrez

Tofé²,

Manghi³

et al. 2014

Diabetes Care

281

341

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OBJECTIVECompare the efficacy and safety of monotherapy with dulaglutide, a once-weekly GLP-1 receptor agonist, to metformin-treated patients with type 2 diabetes. The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A 1c (HbA 1c ) at 26 weeks. RESEARCH DESIGN AND METHODSThis 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin. Patients (N = 807) had HbA 1c ‡6.5% ( ‡48 mmol/mol) and £9.5% (£80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period. RESULTSAt 26 weeks, changes from baseline HbA 1c (least squares [LS] mean 6 SE) were: dulaglutide 1.5 mg, 20.78 6 0.06% (28.5 6 0.70 mmol/mol); dulaglutide 0.75 mg, 20.71 6 0.06% (27.8 6 0.70 mmol/mol); and metformin, 20.56 6 0.06% (26.1 6 0.70 mmol/mol). Dulaglutide 1.5 and 0.75 mg were superior to metformin (LS mean difference): 20.22% (22.4 mmol/mol) and 20.15% (21.6 mmol/mol) (one-sided P < 0.025, both comparisons), respectively. Greater percentages reached HbA 1c targets <7.0% (<53 mmol/mol) and £6.5% (£48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons). No severe hypoglycemia was reported. Compared with metformin, decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg. Over 52 weeks, nausea, diarrhea, and vomiting were the most common adverse events; incidences were similar between dulaglutide and metformin. CONCLUSIONSDulaglutide improves glycemic control and is well tolerated as monotherapy in patients with early stage type 2 diabetes.Muscle and liver insulin resistance and b-cell failure represent the core pathophysiologic defects in type 2 diabetes. In addition, there is increasing evidence that the gastrointestinal (GI) tract plays an essential role in the development of carbohydrate intolerance of type 2 diabetes (1). The incretin concept suggests that ingested glucose results in a considerably larger and more sustained insulin secretion compared with glucose administered intravenously due to the release of two intestinal-derived

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“…In one randomized, multicenter, double-blind, parallel-group study, the incidence of GI AEs in subjects receiving albiglutide 30 mg weekly was less (29.0%) than that observed for the highest biweekly (54.3%) and monthly doses (55.9%) of albiglutide or exenatide [46]. In a randomized, placebo-controlled, double-blind study of overweight patients with T2DM, nausea occurred in 13.6% of those in the dulaglutide group compared with 7.6% in the placebo group [47]. One study examining the US FDA database of reported AEs from 2004 to 2009 found evidence of increased risk of pancreatitis with exenatide and cautioned about long-term use [48].…”

Section: Safety Of Long-acting Glp-1rasmentioning

confidence: 99%

Optimizing glycemic control: lixisenatide and basal insulin in combination therapy for the treatment of Type 2 diabetes mellitus

Aronson

2013

Expert Review of Clinical Pharmacology

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The effects of LY2189265, a long-acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study

Abstract: LY2189265, given to overweight/obese patients with type 2 diabetes for 16 weeks in combination with OAMs, was relatively well tolerated and significantly reduced A1c, blood glucose and body weight.

Cited by 80 publications

References 26 publications

Efficacy and Safety of Dulaglutide Added Onto Pioglitazone and Metformin Versus Exenatide in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-1)

Efficacy and Safety of Dulaglutide Added Onto Pioglitazone and Metformin Versus Exenatide in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-1)

Efficacy and Safety of Dulaglutide Monotherapy Versus Metformin in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-3)

Optimizing glycemic control: lixisenatide and basal insulin in combination therapy for the treatment of Type 2 diabetes mellitus

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