Endocrine Abstracts

Objective

VERIFY demonstrated the long-term benefits of an early combination (EC) treatment strategy compared with initial metformin monotherapy (MET) followed by sequential intensification in a multiethnic population with newly diagnosed type 2 diabetes mellitus (T2DM). The results for European patients enrolled in VERIFY are presented.

Methods

Adult patients with T2DM (≤2 years) and mild hyperglycaemia (glycated haemoglobin [HbA1c] 6.5–7.5%) were randomised 1:1 to either EC (vildagliptin plus metformin) or MET. The primary endpoint was time to initial treatment failure (TF), defined as HbA1c ≥7% at two consecutive scheduled visits after randomisation. If initial treatment did not maintain HbA1c <7%, patients on MET received vildagliptin. Time to second TF was when patients in both groups were receiving and failing on combination.

Results

Eligible patients from Europe (N = 1048) were assigned to EC (n = 523) or MET (n = 525). The 5-year incidence of initial TF was 45.3% with EC and 61.2% with MET. The median time to TF with MET was 36.6 (interquartile range 18.0–not reached [NE]) months; while for EC it was, 61.9 (29.9–NE) months. Risk of initial and secondary TF was reduced with EC when compared to MET (hazard ratio [HR] 0.59 [95% confidence interval {CI}: 0.50–0.70]; P <0.0001 and HR 0.84 [95% CI: 0.68–1.03]; P = 0.0898, respectively). A greater proportion of patients in the EC group had consistently lower HbA1c levels compared with MET group. Time to initial TF with EC was also lower for predefined subgroups of HbA1c, BMI, age, gender, smoking status, and estimated glomerular filtration rate. Overall safety and tolerability profile was similar between treatment groups; incidence of hypoglycaemic events was 0.3% with EC and 0.2% with MET.

Conclusion

Consistent with the global population, EC therapy provided greater and durable long-term benefits compared with the standard-of-care metformin monotherapy in patients with newly diagnosed T2DM from Europe.