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Secondary Outcome: Secondary Outcomes: Changes in waist circumference, body fat, body lean mass, and metabolic risk factors including levels of plasma glucose, insulin sensitivity, serum lipids, and blood pressure Statistical Analysis Full details previously published 2 and can also be found in the STEP group statistical analysis plan at NEJM.org Statistical analysis approach sought strong control for type I error All endpoints addressing intervention efficacy were analyzed using intention-to-treat approach All endpoints addressing intervention safety were analyzed using per-protocol approach Efficacy endpoints analyzed using 2 estimands Treatment Policy Estimand: intention to treat analysis

If additional glycemic control is needed: Increase to 9 mg orally once a day

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The share who report ever taking these drugs rises to about four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter (26%) of adults who have been told they have heart disease, and one in five (22%) adults who have been told by a doctor that they are overweight or obese in the past five years (some of whom also have diabetes or heart disease)

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