Study end points
Cancer, hyperinsulinemia
CANCER, SECONDARY, INSULIN RESISTANCE, HYPERINSULINEMIA
The primary end point was a group of metrics that reflected the metabolic consequences of ADT including development of hyperinsulinemia and insulin resistance, comparing metformin to placebo in men receiving ADT. Subjects had normal oral glucose tolerance test at baseline. Measurements of metabolic consequences including weight, waist circumference, fasting serum glucose and fasting serum insulin levels were measured in intervals of 4 weeks, results presented at week 12 and week 28. In addition, serum metformin concentration and blood metformin concentration analysis for downstream mTOR protein target inhibition was assessed.Secondary endpoints included PSA response, defined as a PSA ≤4 ng/ml or PSA <0.02 value at 7 months. A rise of PSA over 25% and PSA ≥2 ng/ml above the nadir required the clinician to repeat PSA again in one month to confirm the further rise and possible treatment failure. Tolerability was followed as a secondary endpoint as is defined by the National Cancer Institute Common Terminology Criteria for AEs (Version 4.0), of metformin and ADT compared to ADT alone.