Once-Weekly Exenatide Versus Once- or Twice-Daily Insulin Detemir

Davies, Melanie J.; Heller, Simon; Sreenan, Séamus; Sapin, Hélène; Adetunji, O; Tahbaz, Arash; Vora, Jiten

doi:10.2337/dc12-1333

Cited by 66 publications

(59 citation statements)

References 36 publications

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“…In humans with type 2 DM, exenatide ER once weekly was superior to other GLP‐1 analogues in controlling blood glucose concentrations . Exenatide ER, in addition to PO administered antidiabetic agents, also was able to provide better glycemic control than insulin detemir . The present study shows that the percentage of cats that achieved good metabolic control was higher in the exenatide ER group than in the placebo group (93.3% vs. 66.7%, respectively) when cats in remission were grouped together with those with good metabolic control.…”

Section: Discussionmentioning

confidence: 57%

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Effect of the Glucagon‐like Peptide‐1 Analogue Exenatide Extended Release in Cats with Newly Diagnosed Diabetes Mellitus

Riederer

Zini

Salesov

et al. 2015

Veterinary Internal Medicne

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BackgroundExenatide extended release (ER) is a glucagon‐like peptide‐1 analogue that increases insulin secretion, inhibits glucagon secretion and induces satiation in humans with type 2 diabetes mellitus. The use of exenatide ER is safe and stimulates insulin secretion in healthy cats.ObjectivesThe objective of this study is to assess the safety of exenatide ER and its effect on body weight, remission and metabolic control in newly diagnosed diabetic cats receiving insulin and a low‐carbohydrate diet.AnimalsThirty client‐owned cats.MethodsProspective placebo‐controlled clinical trial. Cats were treated with exenatide ER or 0.9% saline, administered SC, once weekly. Both groups received insulin glargine and a low‐carbohydrate diet. Exenatide ER was administered for 16 weeks, or in cats that achieved remission it was given for 4 weeks after discontinuing insulin treatment. Nonparametric tests were used for statistical analysis.ResultsCats in the exenatide ER and placebo groups had transient adverse signs including decreased appetite (60% vs. 20%, respectively, P = .06) and vomiting (53% vs. 40%, respectively, P = .715). Body weight increased significantly in the placebo group (P = .002), but not in cats receiving exenatide ER. Cats on exenatide ER achieved remission or good metabolic control in 40% or 89%, respectively, whereas in control cats percentages were 20% or 58% (P = .427 and P = .178, respectively).Conclusion and clinical importanceExenatide ER is safe in diabetic cats and does not result in weight gain. Our pilot study suggests that, should there be an additional clinically relevant beneficial effect of exenatide ER in insulin‐treated cats on rate of remission and good metabolic control, it would likely approximate 20% and 30%, respectively.

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Section: Discussionmentioning

confidence: 57%

“…In humans with type 2 DM, treatment with GLP‐1 analogues is associated with weight loss, whereas insulin glargine treatment is associated with weight gain . Weight loss was described in healthy cats during treatment with exenatide or liraglutide .…”

Section: Discussionmentioning

confidence: 99%

Effect of the Glucagon‐like Peptide‐1 Analogue Exenatide Extended Release in Cats with Newly Diagnosed Diabetes Mellitus

Riederer

Zini

Salesov

et al. 2015

Veterinary Internal Medicne

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“…Biotherapeutics are increasingly being used to treat a wide range of serious illnesses requiring chronic drug administration [1][2][3][4]. Biotherapeutics offer several attractive features, including high selectivity and specificity, good solubility and stability, long persistence in the body, and low risk for bioconversion to toxic metabolites [5].…”

Section: Introductionmentioning

confidence: 99%

Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer: A Randomized, Crossover Study in Healthy Subjects

et al. 2015

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Abstract. Monoclonal antibody biotherapeutics are often administered by subcutaneous (SC) injection. Due to dose requirements and formulation limitations, SC injections >1 mL are often required. We used a viscous placebo buffer (5 cP), characteristic of a high-concentration antibody formulation, to investigate the effect of dose volume and injection rate on the tolerability of higher-volume SC injections. In this randomized, crossover, single-center study, 48 healthy adults received one 1.2-mL bolus injection over 5 s and three 3.5-mL injections over 1, 4, and 10 min in different abdominal quadrants, with each injection separated by approximately 2 h. The primary objective was to compare pain scores associated with the injections, immediately after administration and 1 h later, using a 100-mm visual analog scale (VAS). Secondary objectives included assessment of adverse events, including injection site reactions and swelling. Mean age was 38.4 (11.6) years and 20 subjects (42%) were female. Lowest mean VAS score was for the 10-min (6.83 mm) and highest for the 1-min injection (19.13 mm). One hour after administration, mean VAS scores were <3.5 mm for all injections. Swelling was similar among the three 3.5-mL injections. After needle removal, leakage occurred following 14 (29%) 1.2-mL injections, eight (17%) 4-min injections, five (10%) 1-min injections, and four (8%) 10-min injections. Fifteen subjects (31%) experienced an adverse event, none of which was serious, fatal, or led to study discontinuation. All injection durations were well tolerated, suggesting a single large-volume SC injection of a biotherapeutic agent could be used instead of multiple injections.

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“…In a study involving 456 patients with T2DM treated with metformin alone or with a sulfonylurea, addition of exenatide once weekly resulted in similar HbA 1c reductions to addition of insulin glargine; the effect of exenatide once weekly persisted at 3 years 222,236,239 . Similarly, addition of exenatide once weekly to oral glucose-lowering medication resulted in greater HbA 1c reductions over 26 weeks than addition of once daily or twice daily insulin detemir 239,259 . In the extension phase of the DURATION-1 trial 260 , patients received exenatide once weekly for up to 5 years, and improvements in HbA 1c and FPG were maintained over this period.…”

Section: Pharmacodynamicsmentioning

confidence: 89%

Pharmacology and therapeutic implications of current drugs for type 2 diabetes mellitus

2016

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Type 2 diabetes mellitus (T2DM) is a global epidemic that poses a major challenge to health-care systems. Improving metabolic control to approach normal glycaemia (where practical) greatly benefits long-term prognoses and justifies early, effective, sustained and safety-conscious intervention. Improvements in the understanding of the complex pathogenesis of T2DM have underpinned the development of glucose-lowering therapies with complementary mechanisms of action, which have expanded treatment options and facilitated individualized management strategies. Over the past decade, several new classes of glucose-lowering agents have been licensed, including glucagon-like peptide 1 receptor (GLP-1R) agonists, dipeptidyl peptidase 4 (DPP-4) inhibitors and sodium/glucose cotransporter 2 (SGLT2) inhibitors. These agents can be used individually or in combination with well-established treatments such as biguanides, sulfonylureas and thiazolidinediones. Although novel agents have potential advantages including low risk of hypoglycaemia and help with weight control, long-term safety has yet to be established. In this Review, we assess the pharmacokinetics, pharmacodynamics and safety profiles, including cardiovascular safety, of currently available therapies for management of hyperglycaemia in patients with T2DM within the context of disease pathogenesis and natural history. In addition, we briefly describe treatment algorithms for patients with T2DM and lessons from present therapies to inform the development of future therapies.

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Once-Weekly Exenatide Versus Once- or Twice-Daily Insulin Detemir

Cited by 66 publications

References 36 publications

Effect of the Glucagon‐like Peptide‐1 Analogue Exenatide Extended Release in Cats with Newly Diagnosed Diabetes Mellitus

Effect of the Glucagon‐like Peptide‐1 Analogue Exenatide Extended Release in Cats with Newly Diagnosed Diabetes Mellitus

Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer: A Randomized, Crossover Study in Healthy Subjects

Pharmacology and therapeutic implications of current drugs for type 2 diabetes mellitus

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