Bydureon SDT (exenatide XR) / AstraZeneca - LARVOL DELTA

Exenatide once weekly combined with metformin reduced glycemic variability in type 2 diabetes by using flash glucose monitoring system. (PubMed, World J Diabetes) - "EXQW combined with metformin can effectively improve blood glucose levels, reduce GV, and improve metabolic indicators. However, there is still a risk of nocturnal hypoglycemia, and careful attention should be paid to patients with EXQW treatment."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Treatment persistence in patients with type 2 diabetes mellitus treated with GLP-1 receptor agonists in clinical practice in Sweden. (PubMed, Diabetes Obes Metab) - "Our study suggests that in clinical practice in Sweden, there is a greater persistence of treatment among patients initiating dulaglutide, compared with those on exenatide QW, liraglutide, and lixisenatide. Persistence with the index GLP-1 RA was closely correlated with positive clinical outcomes and should thus be considered a critical factor of patient-centric treatment in Sweden."

Clinical • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Long-Acting Injectable GLP-1 Receptor Agonists for the Treatment of Adults with Type 2 Diabetes: Perspectives from Clinical Practice. (PubMed, Diabetes Metab Syndr Obes) - "Randomized controlled trials (RCTs) have consistently shown glycemic and extra-glycemic benefits of long-acting injectable glucagon-like-peptide-1 receptor agonists (GLP-1RAs, liraglutide, albiglutide, exenatide once-weekly, dulaglutide, and semaglutide) in terms of reduction in the rates of cardiovascular events and mortality among patients with type 2 diabetes...Finally, multiple RWS reported better cardio-renal outcomes with GLP-1RAs than with DPP-4i, while initial findings from RWS described a weaker cardiovascular protection compared to SGLT-2i. Therefore, there is the need for further RWS and RCTs comparing these different classes of glucose lowering medications."

Clinical • Journal • Review • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Exenatide Once Weekly for Smoking Cessation (clinicaltrials.gov) - P1/2; N=82; Completed; Sponsor: The University of Texas Health Science Center, Houston; Recruiting ➔ Completed; Trial completion date: Jun 2020 ➔ Jan 2020; Trial primary completion date: Jun 2020 ➔ Jan 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Tobacco Cessation

MSA: Exenatide Once-weekly as a Treatment for Multiple System Atrophy (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: University College, London; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy

GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. (PubMed, Mol Metab) - "Today, GLP-1 RAs are injected twice daily (exenatide b.i.d.), once daily (lixisenatide, liraglutide) or once weekly (exenatide once weekly, dulaglutide, albiglutide, semaglutide)...Novel indications for GLP-1 RAs outside type 2 diabetes, like type 1 diabetes, neuro-degenerative diseases, and psoriasis, are being explored. Thus, within 15 years of their initial introduction, GLP-1 RAs have become a well-established class of glucose-lowering agents which has the potential for further development and growing impact for the treatment of type 2 diabetes and potentially other diseases."

Journal • Atherosclerosis • Cardiovascular • CNS Disorders • Congestive Heart Failure • Dermatology • Diabetes • Dyslipidemia • Heart Failure • Hypoglycemia • Immunology • Metabolic Disorders • Myocardial Infarction • Psoriasis • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

DAPA, EQW, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS) (clinicaltrials.gov) - P3; N=119; Completed; Sponsor: Woman's; Active, not recruiting ➔ Completed

Clinical • Trial completion • Genetic Disorders • Obesity • Polycystic Ovary Syndrome

Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study. (PubMed, BMJ Open Diabetes Res Care) - P3 | "Switching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns."

Clinical • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] Asian subpopulations may exhibit greater cardiovascular benefit from long-acting glucagon-like peptide I receptor agonists (EASD 2020) - "Materials and Six CVOTs were included: LEADER (liraglutide), SUSTAIN-6 (semaglutide), EXSCEL (exenatide once weekly), HARMONY (albiglutide), REWIND (dulaglutide) and PIONEER 6 (oral semaglutide)... Long-acting GLP-1 RAs reduced risks of MACE and CV deaths in high-risk patients with type 2 diabetes mellitus. Our findings from synthesized data including recently published CVOTs support a particularly effective reduction in CV events with GLP-1 RA in Asian populations."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Type 2 diabetes and the kidney: insights from cardiovascular outcome trials. (PubMed, Diabetes Obes Metab) - "Most trials with dipeptidyl-peptidase inhibitors (SAVOR-TIMI 53 with saxagliptin, EXAMINE with alogliptin, TECOS with sitagliptin, and CARMELINA with linagliptin) and with glucagon-like peptide-1 receptor agonists (GLP-1RAs) (ELIXA with lixisenatide, LEADER with liraglutide, SUSTAIN-6 with semaglutide, EXCSEL with exenatide once-weekly, and HARMONY with albiglutide) pointed towards reduced albuminuria, which is a surrogate endpoint possibly heralding renal function preservation. The three trials with sodium-glucose co-transporter-2 inhibitors (SGLT-2is) (empagliflozin, canagliflozin and dapagliflozin) also showed a salutary effect on long-term estimated glomerular filtration rate, suggesting that SGLT-2is are more effective at mitigating loss of kidney function than incretin-based therapies; moreover, SGLT-2is also have the advantage of plausible haemodynamic mechanisms for improved renal outcomes. Despite some residual limitations linked to differences in study..."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Similar effectiveness of dapagliflozin versus GLP-1 receptor agonists on combined endpoints in routine clinical practice. A multicenter retrospective study. (PubMed, Diabetes Obes Metab) - "In routine specialist care, initiation of dapagliflozin can be as effective as initiation of a GLP-1RA for the attainment of combined risk factor goals."

Journal • Retrospective data • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Adherence, Persistence, Glycemic Control and Costs Among Patients with Type 2 Diabetes Initiating Dulaglutide Compared with Liraglutide or Exenatide QW at 12 Months Follow-Up in a US Real-World Setting. (PubMed, Diabetes Obes Metab) - "Adherence and persistence are important considerations in patient-centric treatment selection for patients with T2D. Higher adherence and persistence for dulaglutide compared to liraglutide or exenatide QW are relevant criteria when choosing GLP-1 RA treatment for patients with T2D."

Clinical • Journal • Real-World Evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Predictive factors associated with 3 years of response to HbA1c goal with exenatide QW or insulin glargine: Post hoc analysis of DURATION-3. (PubMed, Diabetes Obes Metab) - "A regression model estimated likelihood of sustained response with either treatment. This analysis provides a helpful tool for predicting sustained response with exenatide QW or IG."

Biomarker • Journal • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. (PubMed, Diabetes Care) - "In this exploratory analysis, among those individuals who completed the trial without rescue therapy, there was clinically relevant efficacy over 2 years with exenatide QW plus dapagliflozin, with no unexpected safety findings."

Clinical • Journal • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Exenatide Once Weekly: Effectiveness, Tolerability, and Discontinuation Predictors in a Real-World Setting. (PubMed, Clin Ther) - "EOW treatment, in a real-world setting, offers sustained and effective glycemic control and weight loss over 18 months in patients with T2DM. Diabetes duration and basal insulin therapy, however, may affect the outcome of EOW treatment, suggesting that early initiation of EOW could improve glycemic control and reduce the risk of treatment discontinuation."

Clinical • Journal • Real-World Evidence • Allergy • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

DAPA, EQW, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS) (clinicaltrials.gov) - P3; N=119; Active, not recruiting; Sponsor: Woman's; Recruiting ➔ Active, not recruiting; Trial primary completion date: Apr 2020 ➔ Jul 2020

Clinical • Enrollment closed • Trial primary completion date • Genetic Disorders • Obesity • Polycystic Ovary Syndrome

A Review of the Long-Term Efficacy, Tolerability, and Safety of Exenatide Once Weekly for Type 2 Diabetes. (PubMed, Adv Ther) - "ExeOW is a well-tolerated and convenient option for long-term treatment of T2D allowing significant and persistent glycemic control with moderate weight loss and low risk of hypoglycemia unless associated with sulfonylureas."

Journal • Review • Biosimilar • Diabetes

An Indirect Comparison of Changes in the Impact of Weight on Quality of Life Among Subjects with Type 2 Diabetes Treated with Antihyperglycemic Agents in Dual Therapy with Metformin. (PubMed, Diabetes Ther) - "These findings suggest that improvements in the impact of weight on health-related quality of life may be greater with canagliflozin than exenatide, sitagliptin, and pioglitazone. This analysis also demonstrates the application of indirect comparison methodology to PRO data and provides examples of advantages and challenges associated with performing indirect comparisons of PRO data."

Journal • Biosimilar • Diabetes

Effectiveness of dulaglutide vs liraglutide and exenatide once-weekly. A real-world study and meta-analysis of observational studies. (PubMed, Metabolism) - "In a real-world scenario, dulaglutide reduced HbA1c more than liraglutide. Conversely, we found similar effect of dulaglutide and exeOW, with statistical differences arising solely when results were meta-analysed with those from other observational studies. Lack of up-titration for liraglutide and higher discontinuation rate for exeOW likely influenced the estimated treatment difference."

Journal • Observational data • Real-World Evidence • Retrospective data • Diabetes

Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study. (PubMed, J Diabetes Complications) - "Treatment with exenatide QW for 7 years was associated with sustained improvements in glycemic control and several cardiovascular risk factors."

Clinical • Journal • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: the DURATION-NEO-2 randomized clinical study. (PubMed) - Diabetes Obes Metab - P3; "This study demonstrated that exenatide QWS-AI reduced HbA1c more than sitagliptin or placebo and was well tolerated. ClinicalTrials.gov identifier: NCT01652729."

Journal • Biosimilar • Diabetes

Post hoc analysis of the Exenatide-PD trial - factors that predict response. (PubMed, Eur J Neurosci) - "In the subgroup analyses, exenatide once-weekly was associated with broadly improved outcome measures assessing motor severity, non-motor symptoms, cognition and quality of life across all subgroups, however tremor-dominant phenotype and lower MDS-UPDRS Part-2 scores predicted greatest motor response to exenatide and there was an indication that patients with older age of onset and disease duration over 10 years responded less well. While patients with a range of demographic and clinical factors can potentially benefit from exenatide once-weekly, these data support an emphasis towards recruiting patients at earlier disease in future planned clinical trials of GLP-1 receptor agonists in PD."

Journal • Retrospective data • Diabetes • Gene Therapies • Metabolic Disorders • Movement Disorders • Parkinson's Disease • Type 2 Diabetes Mellitus

MSA: Exenatide Once-weekly as a Treatment for Multiple System Atrophy (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: University College, London

Clinical • New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

Exenatide once-weekly as a treatment for Multiple System Atrophy. (clinicaltrialsregister.eu) - P2; N=50; Ongoing; Sponsor: University College London (UCL)

Clinical • New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

Effect of the exenatide plus dapagliflozin combination on fatty liver index and insulin resistance in type 2 diabetes patients: the DURATION-8 trial (EASD 2018) - P3; "Exenatide once weekly (ExQW) and dapagliflozin (DAPA) reduce glycaemia and body weight in T2DM patients. Combination of ExQW and DAPA has demonstrated efficacy in reducing body weight and other metabolic parameters in T2DM patients inadequately controlled on metformin. ExQW+DAPA also showed an improvement in FLI and insulin resistance that was sustainable up to 52 weeks. "

Clinical • Biosimilar • Diabetes • Obesity