A practice-based approach to the 2012 position statement of the American Diabetes Association and the European Association for the Study of Diabetes

Schwartz, Stanley

doi:10.1185/03007995.2013.798637

Cited by 7 publications

(6 citation statements)

References 37 publications

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“…Hypoglycaemia risk was similar to that reported with other GLP‐1 receptor agonists when used in combination with metformin and when comparable glycaemic thresholds for hypoglycaemia definitions are used (3.0–3.1 mmol/l) . The low incidence of hypoglycaemia in dulaglutide‐treated participants is considered to be related to its mechanism of action, a glucose‐dependent enhancement of insulin secretion that avoids β ‐cell overstimulation and hyperinsulinaemia .…”

Section: Discussionsupporting

confidence: 71%

Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study

Weinstock

Guerci

Umpiérrez

et al. 2015

Diabetes Obesity Metabolism

118

106

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AimsTo compare the once‐weekly glucagon‐like peptide‐1 (GLP‐1) receptor dulaglutide with the dipeptidyl peptidase‐4 (DPP‐4) inhibitor sitagliptin after 104 weeks of treatment.MethodsThis AWARD‐5 study was a multicentre, double‐blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks. Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure. A total of 1098 participants with HbA1c concentrations ≥7.0% (≥53.0 mmol/mol) and ≤9.5% (≤80.3 mmol/mol) were randomized, and 657 (59.8%) completed the study. We report results for dulaglutide and sitagliptin at the final endpoint.ResultsChanges in HbA1c at 104 weeks were (least squares mean ± standard error) −0.99 ± 0.06% (−10.82 ± 0.66 mmol/mol), −0.71 ± 0.07% (−7.76 ± 0.77 mmol/mol) and −0.32 ± 0.06% (−3.50 ± 0.66 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg and sitagliptin, respectively (p < 0.001, both dulaglutide doses vs sitagliptin). Weight loss was greater with dulaglutide 1.5 mg (p < 0.001) and similar with 0.75 mg versus sitagliptin (2.88 ± 0.25, 2.39 ± 0.26 and 1.75 ± 0.25 kg, respectively). Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively). Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups.ConclusionsDulaglutide doses provided superior glycaemic control and dulaglutide 1.5 mg resulted in greater weight reduction versus sitagliptin at 104 weeks, with acceptable safety.

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Section: Discussionsupporting

confidence: 71%

Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study

Weinstock

Guerci

Umpiérrez

et al. 2015

Diabetes Obesity Metabolism

118

106

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“…180 The guidelines recommend less aggressive HbA 1c level goals in patients who are older, have a longer duration of diabetes, and have important comorbidities 59 (based upon the ACCORD, VADT, and ADVANCE trials, in which aggressive sulfonylurea and insulin use was associated with hypoglycemia and weight-gain complications). The guidelines now recognized that there are 9 classes of antidiabetic agents, including the DPP-4 inhibitors and GLP-1 receptor agonists, which are unlikely to cause hypoglycemia and, in my clinical opinion, allow clinicians to be as aggressive in these patients as in those who are younger, have a shorter duration of diabetes, and have no significant comorbidities.…”

Section: Guideline Recommendationsmentioning

confidence: 99%

Evidence-Based Practice Use of Incretin-Based Therapy in the Natural History of Diabetes

Schwartz

2014

Postgraduate Medicine

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The incretin class of anti-hyperglycemic agents, including glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-inhibitors, is an important addition to the therapeutic armamentarium for the management of appropriate patients with type 2 diabetes mellitus as an adjunct to diet and exercise and/or with the agents metformin, sulfonylureas, thiazolidinediones, or any combination thereof. More recently, US Food and Drug Administration (FDA)-approved indications for incretins were expanded to include use with basal insulin. This review article takes an evidence-based practice approach in discussing the importance of aggressive treatment for diabetes, the principles of incretin physiology and pathophysiology, use of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors, and patient types and contexts where incretin therapy has been found beneficial, from metabolic syndrome to overt diabetes.

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“…Several classes of oral and injectable antihyperglycaemic agents with different mechanisms of actions are currently available for T2DM treatment. However, hypoglycaemia and weight gain are among the limitations of some currently available antihyperglycaemic medications .…”

Section: Introductionmentioning

confidence: 99%

“…Type 2 diabetes mellitus (T2DM) is an increasingly common endocrine disorder characterized by progressive loss of beta cell function leading to dysregulation of glucose homeostasis and chronic hyperglycaemia, which is associated with an increased risk of myocardial infarction, stroke, and peripheral arterial disease, as well as chronic kidney disease, neuropathy, and retinopathy . Controlling hyperglycaemia is pivotal to avoid the comorbidities of T2DM . Several classes of oral and injectable antihyperglycaemic agents with different mechanisms of actions are currently available for T2DM treatment.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program

Jendle

Grunberger

Blevins

et al. 2016

Diabetes Metabolism Res

123

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SummaryDulaglutide (DU) is a once weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for the treatment of type 2 diabetes mellitus (T2DM). Glycaemic efficacy and safety characteristics of dulaglutide have been assessed in six Phase 3 studies in the AWARD program. The objective of this review article is to summarize these results from the six completed AWARD studies. At the primary endpoint, in five of the six studies, once weekly dulaglutide 1.5 mg was superior to the active comparator [exenatide, insulin glargine (two studies), metformin, and sitagliptin], with a greater proportion of patients reaching glycated hemoglobin A1c (HbA1c) targets of <7.0% (53.0 mmol/mol) and ≤6.5% (47.5 mmol/ mol). Dulaglutide 1.5 mg was non-inferior to liraglutide in AWARD-6. Once weekly dulaglutide 0.75 mg was evaluated in five of these trials and demonstrated superiority to the active comparator in four of five AWARD studies (exenatide, glargine, metformin, and sitagliptin), and non-inferiority to glargine in the AWARD-2 study. Similar to other GLP-1 receptor agonists, treatment with dulaglutide was associated with weight loss or attenuation of weight gain and low rates of hypoglycaemia when used alone or with non-insulin-secretagogue therapy. The most frequently reported adverse events were gastrointestinal, including nausea, vomiting, and diarrhea. The incidence of dulaglutide antidrug antibody formation was 1-2.8% with rare injection site reactions. In conclusion, dulaglutide is an effective treatment for T2DM and has an acceptable tolerability and safety profile.

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A practice-based approach to the 2012 position statement of the American Diabetes Association and the European Association for the Study of Diabetes

Cited by 7 publications

References 37 publications

Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study

Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study

Evidence-Based Practice Use of Incretin-Based Therapy in the Natural History of Diabetes

Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program

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