medwireNews: Use of a titratable, fixed-ratio combination of insulin glargine and the glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide helps overweight patients with long-standing Type 2 diabetes to attain glycaemic control, shows a randomised trial.
The 367 patients assigned to the combination treatment injected it once daily, no more than 1 hour before breakfast. The starting dose was set according to their stable insulin glargine dose, determined in all patients during a 6-week run-in phase, and was titrated thereafter according to patients’ fasting plasma glucose levels.
During 30 weeks of treatment, average glycated haemoglobin (HbA1c) levels fell from 8.1% in all patients at baseline to 6.9% in the combination group, which was significantly lower than the 7.5% achieved by 369 patients assigned to insulin glargine alone (randomisation was stratified according to baseline HbA1c <8% or ≥8%).
Vanita Aroda (Medstar Health Research Institute, Hyattsville, Maryland, USA) and co-researchers attribute the improvement with insulin monotherapy to careful dose adjustment, but say the patients did not reach their HbA1c target “because further therapy is needed to address postprandial hyperglycemia.”
Combination therapy therefore reduced HbA1c “to a meaningful 6.9% by addressing simultaneously fasting and postprandial hyperglycemia in a single injection formulation”, they write in Diabetes Care.
And the addition of lixisenatide appeared to have beneficial effects on the weight gain associated with insulin use; patients in the combination group lost 0.7 kg, on average, compared with a 0.7 kg gain in the insulin only group, resulting in a significant 1.4 kg difference between the two.
Hypoglycaemia occurred at a similar rate of around 40% in both groups. Nausea and vomiting were markedly more frequent in the combination than insulin only groups, at 10.4% versus 0.5% and 3.6% versus 0.5%, respectively. But the researchers stress that these rates are lower than previously reported for lixisenatide monotherapy, and just four (1.1%) patients discontinued treatment because of nausea, and none because of vomiting.
They believe that dose titration according to fasting plasma glucose and patient tolerance “clearly mitigates” the gastrointestinal adverse events of the medication.
The trial participants all had long-standing diabetes, of an average 12 years’ duration, and were insulin-dependent, with 95% also taking at least one oral antidiabetic medication (which they stopped at study entry), yet failing to achieve glycaemic control.
The findings therefore support use of the fixed-ratio combination treatment “to simplify and more effectively intensify basal insulin treatment in this challenging patient population with long-standing type 2 diabetes”, concludes the team.
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