Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial

Diamant, Michaëla; Gaal, Luc Van; Guerci, Bruno; Stranks, Stephen N; Han, Jenny; Malloy, Jaret; Boardman, Marilyn K.; Trautmann, Michael E.

doi:10.1016/s2213-8587(14)70029-4

Cited by 142 publications

(154 citation statements)

References 29 publications

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“…The gastrointestinal side effects are less frequent and mild than for the other GLP-1 RAs, presumably because the final therapeutic blood level is achieved relatively slowly due to the gradual accumulation of the peptide over a period of up to 6-7 weeks. The phase 3 clinical trials of exenatide ER, consisting of six studies, were designated as the DURATION studies, [27][28][29][30][31][32][33][34][35][36] (Table 2). These included two randomized placebo-controlled trials 27,31 and four open-label studies.…”

Section: Exenatide Ermentioning

confidence: 99%

The Clinical Impact of GLP-1 Receptor Agonists in Type 2 Diabetes: Focus on the Long-Acting Analogs

Rodbard¹

2018

Diabetes Technology & Therapeutics

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GLP-1 receptor agonists (GLP-1 RAs), introduced for clinical use in 2005, have excellent potency in reducing HbA 1c and mean glucose, improving fasting plasma glucose, inducing weight loss or protecting against the weight gain associated with insulin therapy, reducing appetite, and delaying gastric emptying. Two of these medications, liraglutide and semaglutide, appear to have cardioprotective effects as reflected in cardiovascular outcomes studies. The GLP-1 RAs are associated with gastrointestinal side effects that tend to diminish over time. They have very low risk of hypoglycemia unless used in conjunction with insulin or insulin secretagogues. Two coformulations of GLP-1 RAs together with long-acting basal insulin are available for daily use. The original GLP-1 RA, exenatide, requires twice-daily injections; two short-acting analogs are given once daily. Three currently available long-acting GLP-1 RAs are injected once weekly, providing greater convenience and potentially improving patient adherence. Semaglutide appears to be the most effective in terms of HbA 1c reduction and weight loss. GLP-1 RAs can be combined with all classes of antihyperglycemic agents except DPP-4 inhibitors. Current studies are exploring the use of an implantable osmotic pump for long-term administration of a rapid acting analog (exenatide), an oral preparation of semaglutide, benefits for management of obesity and nonalcoholic steatohepatitis, and mechanisms of cardioprotective effects.

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Section: Exenatide Ermentioning

confidence: 99%

The Clinical Impact of GLP-1 Receptor Agonists in Type 2 Diabetes: Focus on the Long-Acting Analogs

Rodbard¹

2018

Diabetes Technology & Therapeutics

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“…However, clinicians should consider the results from studies of intention-totreat populations wherever possible, because the weight-loss responses to treatment may differ compared with completer populations (44). The onceweekly extended-release formulation of exenatide has consistently demonstrated weight-loss properties across multiple clinical trials (45,46), showing a mean weight loss of -2.67 kg versus comparator drugs (i.e., exenatide twicedaily, insulin, liraglutide, pioglitazone) (43). Gastrointestinal side effects, such as nausea and vomiting, although rare, occurred as the most commonly reported adverse events (AEs), and most AEs were of mild-to-moderate severity and transient (46).…”

Section: Glp-1 Receptor Agonistsmentioning

confidence: 99%

Weight Management in Type 2 Diabetes: Current and Emerging Approaches to Treatment

2015

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Diabetes is a growing global health concern, as is obesity. Diabetes and obesity are intrinsically linked: obesity increases the risk of diabetes and also contributes to disease progression and cardiovascular disease. Although the benefits of weight loss in the prevention of diabetes and as a critical component of managing the condition are well established, weight reduction remains challenging for individuals with type 2 diabetes due to a host of metabolic and psychological factors. For many patients, lifestyle intervention is not enough to achieve weight loss, and alternative options, such as pharmacotherapy, need to be considered. However, many traditional glucose-lowering medications may lead to weight gain. This article focuses on the potential of currently available pharmacological strategies and on emerging approaches in development to support the glycemic and weight-loss goals of individuals with type 2 diabetes. Two pharmacotherapy types are considered: those developed primarily for blood glucose control that have a favorable effect on body weight and those developed primarily to induce weight loss that have a favorable effect on blood glucose control. Finally, the potential of combination therapies for the management of obese patients with type 2 diabetes is discussed.

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“…The most common AEs leading to discontinuation of semaglutide were GI in nature and, overall, most cases of GI AEs were mild or moderate and of a short duration 12, 13, 14, 15, 16, 23, 24. GI AEs are commonly observed across the GLP‐1RA class,2, 9 and may affect treatment outcomes in the real‐world setting.…”

Section: Discussionmentioning

confidence: 99%

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme

DeVries

Desouza

Bellary

et al. 2018

Diabetes Obesity Metabolism

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AimTo evaluate the potential for semaglutide to help people with type 2 diabetes (T2D) achieve glycated haemoglobin (HbA1c) targets while avoiding unwanted outcomes, such as weight gain, hypoglycaemia and gastrointestinal (GI) side effects.Materials and methodsData from the phase IIIa SUSTAIN 1 to 5 clinical trials were analysed. Participants had inadequately controlled T2D and were drug‐naïve (SUSTAIN 1) or on a range of background treatments (SUSTAIN 2 to 5). The main protocol‐specified composite endpoint was the proportion of participants achieving HbA1c <53 mmol/mol (7.0%) at end of treatment (30 or 56 weeks) without weight gain and with no severe or blood glucose (BG)‐confirmed symptomatic hypoglycaemia. A post hoc composite endpoint was the proportion of participants achieving the primary composite endpoint without moderate or severe GI adverse events (AEs).ResultsAcross the SUSTAIN trials 1 to 5, 3918 participants with T2D were randomized to once‐weekly subcutaneous semaglutide 0.5 mg, 1.0 mg, or comparators (placebo, sitagliptin 100 mg, exenatide extended release 2.0 mg or insulin glargine). The proportion of participants achieving HbA1c <53 mmol/mol (7.0%) with no weight gain and no severe/BG‐confirmed symptomatic hypoglycaemia was 47% to 66% (semaglutide 0.5 mg) and 57% to 74% (semaglutide 1.0 mg) vs 7% to 19% (placebo) and 16% to 29% (active comparators; all P < .0001). More participants achieved the primary composite endpoint with no moderate or severe GI AEs with semaglutide vs comparators (all P < .0001).ConclusionSemaglutide helped more people with T2D achieve HbA1c targets than did comparators in the SUSTAIN 1 to 5 trials, while avoiding unwanted outcomes such as weight gain, hypoglycaemia and GI side effects.

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Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial

Cited by 142 publications

References 29 publications

The Clinical Impact of GLP-1 Receptor Agonists in Type 2 Diabetes: Focus on the Long-Acting Analogs

The Clinical Impact of GLP-1 Receptor Agonists in Type 2 Diabetes: Focus on the Long-Acting Analogs

Weight Management in Type 2 Diabetes: Current and Emerging Approaches to Treatment

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme

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