Adding AstraZeneca’s Byetta (exenatide) to basal insulin glargine/meformin is just as effective at lowering blood sugar in adults with type II diabetes as adding bolus insulin lispro (Lilly’s Humalog), but has the added benefit of helping to reduce weight, suggest new data published in Diabetes Care this week.

The Phase III study, the first to directly compare adding a GLP-1 receptor agonist to basal insulin against a standard basal-bolus insulin regimen, hit its primary target of non-inferiority in reducing levels of HbA1c at 30 weeks (-1.13% and -1.10%, respectively).

According to AZ, the data are particularly significant as Byetta is the first and only short-acting GLP-1 receptor agonist shown to be as effective as rapid-acting meal-time insulin in boosting glycaemic control. The additional benefit of weight loss is also important, “especially in comparison to the weight gain that we usually see in patients taking insulin,” said Grace Vanterpool, Diabetes Nurse Consultant, Featherstone Clinic, Middlesex, UK, noting that “patients are more likely to adhere to a therapy that does not increase, but actually lowers weight”.

Patients on Byetta also showed improvements across a range of factors compared to lispro, including significant reductions in mean body weight (-2.5 kg versus 2.1 kg) and systolic blood pressure (-4.1 mmHg vs 0.4 mmHg), as well as a lower incidence of minor hypoglycaemia (30% vs 41%). And crucially, they also reported greater treatment satisfaction (mean change of 2.19 points vs 1.4 points) and improved quality of life (mean change of 4.4 points vs 0.51 points).

Safety profile

On the downside, the number experiencing treatment-related side effects was greater in the Byetta group, with 47% reporting gastrointestinal adverse events such as nausea, vomiting and diarrhoea compared to 13% taking bolus insulin lispro. But overall the proportion of serious adverse events was found to be similar between the two treatment arms (5.7% vs 7.4%, respectively).

An estimated 2.88 million people in the UK are known to be living with type II diabetes and a further 765,000 people are thought to remain undiagnosed, highlighting the scale of the problem. Obesity is the most potent risk factor for type II diabetes, accounting for 80-85% of the overall risk of developing the disease.

“The majority of people with type II diabetes in the UK are overweight or obese, therefore it’s important that we explore ways to tackle these issues if we want to optimise diabetes management and help patients achieve their treatment goals,”  noted Lisa Anson, president of AstraZeneca UK and Ireland.

PharmaTimes Digital will be publishing an interview with Lisa Anson on Friday.