Context and Objectives: The number of people with diabetes is increasing exponentially in India. Owing to a unique “Asian Indian Phenotype,” Indians develop diabetes a decade earlier and have an earlier onset of complications than Western populations. Therefore, it is essential to evaluate more effective treatment strategies at an earlier stage of disease progression, such as initial combination therapy, in Indian patients.

In this study, we evaluated the efficacy and safety of initial combination therapy with linagliptin plus metformin in comparison to linagliptin or metformin monotherapy in Indian patients with type 2 diabetes mellitus. Methods: This is a subgroup analysis of Indian patients who participated in a Phase III, 24‑week, double‑blind, placebo‑controlled, trial. Overall, 249 Indian patients were randomized to one of six treatment arms (Two free combination therapy arms:…