Which study design describes a trial assessing whether empagliflozin is clinically worse than placebo?

The study design that assesses whether one treatment, in this case empagliflozin, is clinically worse than a placebo is known as a noninferiority trial. In a noninferiority trial, the primary aim is to determine whether the new treatment is not significantly less effective than the standard treatment or placebo, within a predefined margin. This type of design is particularly useful when the new treatment may have other benefits, such as improved safety or tolerance, allowing researchers to demonstrate that it remains effective without being inferior to the existing treatment options.

In the context of empagliflozin versus placebo, the goal would be to show that empagliflozin does not have worse clinical outcomes than placebo, effectively confirming that it is at least as good as the placebo in terms of efficacy. Thus, if the trial concludes that the treatment is not clinically worse than the placebo, it supports the idea that empagliflozin is a viable option for treatment.

Other study designs mentioned do not fit this specific question. For instance, equivalence trials aim to show that two treatments have similar efficacy, while superiority trials seek to demonstrate that one treatment is significantly better than another. Pragmatic trials focus on the effectiveness of interventions in real-world settings rather than controlled environments