The study included 264 patients poorly controlled on metformin, who were randomly chosen receive either IN-105 or placebo. The patients in both arms of the study were allowed to continue taking metformin as background therapy.
Initial data analysis showed that IN-105 did not meet its primary end point of lowering HbA1c levels by 0.7% compared to placebo, although an unexpectedly high placebo response was also observed. The reduction in pre-meal glucose levels in patients receiving placebo strongly suggests behavioral modification which may have confounded the primary endpoint outcome.
Multiple secondary endpoints on both efficacy and safety were met, further strengthening the emerging profile of IN-105. Most notably on efficacy, the IN-105 patient arm demonstrated a statistically significant reduction in post meal glucose levels compared to placebo throughout the duration of the study.