- An early combination strategy consisting of twice-daily vildagliptin with metformin reduced the rate of treatment failure compared with metformin alone in patients with type 2 diabetes (T2D).
Why this matters
- Strategies are needed to reduce treatment failure in some patients with T2D.
- Drug-naive patients with T2D (HbA1c: 6.5%-7.5%) and a BMI of 22-40 kg/m2 were randomly assigned:
- Twice-daily vildagliptin 50 mg plus stable daily doses of metformin 1000, 1500, or 2000 mg (n=983);
- Stable daily doses of metformin 1000, 1500, or 2000 mg plus placebo (n=989).
- Primary endpoint was time to treatment failure, defined as HbA1c ≥7.0%.
- Funding: Novartis.
- Patients treated with vildagliptin had a significantly longer time to initial treatment failure compared with the metformin monotherapy group over the 5-year treatment period (61.9 vs 36.1 months; HR, 0.51; 95% CI, 0.45-0.58; P<.0001>
- Frequency of second failure was also lower in the vildagliptin combination arm vs the placebo arm (HR, 0.74; 95% CI, 0.63-0.86; P<.0001>
- The difference in time to first adjudicated macrovascular event did not reach statistical significance (HR, 0.71; 95% CI, 0.42-1.19; P=.19).
- Small patient numbers and wide confidence intervals in the time to first adjudicated macrovascular event analysis.