Fig. 4

Secondary treatment failure* among patients with early combination versus initial monotherapy followed by vildagliptin addition. CI confidence interval, HbA1c glycated hemoglobin; HR, hazard ratio. *Secondary treatment failure is defined as two consecutive scheduled visits with HbA1c ≥ 7.0% during period 2 (i.e., after period 1 comparing metformin monotherapy versus early combination therapy with metformin and vildagliptin and up to end of period 2 when both groups are on combination therapy after primary treatment failure. The time to secondary treatment failure is the number of days from randomization to the second confirmed HbA1c ≥ 7.0% during consecutive scheduled visits, three months apart, in period 2. The Kaplan Meier estimates were performed for patients who had received at least one randomized medication and one post-randomization efficacy parameter assessed. Patients who had no event and discontinued the study for any reason during period 1 or period 2 were censored at the date of discontinuation. Patients who entered period 3 from period 1 were censored to last study visit prior to start of period 3. Two-sided p value was obtained from a Cox proportional hazards model containing terms for treatment approach. Baseline HbA1c was the value obtained on Day 1, or the value obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if Day 1 measurement was missing