Safety and tolerability of the treatment of youth-onset type 2 diabetes: the TODAY experience.

ABSTRACT:

Objective

Data related to the safety and tolerability of treatments for pediatric type 2 diabetes are limited. The TODAY clinical trial assessed severe adverse events (SAEs) and targeted nonsevere adverse events (AEs) before and after treatment failure, which was the primary outcome (PO).

Research design and methods

Obese 10- to 17-year-olds (N = 699) with type 2 diabetes for <2 years and hemoglobin A1c (A1C) ≤ 8% on metformin monotherapy were randomized to one of three treatments: metformin, metformin plus rosiglitazone (M + R), or metformin plus lifestyle program (M + L). Participants were followed for 2-6.5 years.

Results

Gastrointestinal (GI) disturbance was the most common AE (41%) and was lower in the M + R group (P = 0.018). Other common AEs included anemia (20

SUBMITTER: TODAY Study Group 

PROVIDER: S-EPMC3661822 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature