Observational and clinical trial findings on the comparative effectiveness of diabetes drugs showed agreement.

ABSTRACT:

Objectives

This study compares an observational study of diabetes treatment effectiveness to randomized controlled trials to assess their convergent validity.

Study design and setting

Multivariate models were developed using observational data to describe change in hemoglobin A1c (HbA1c; % unit) and weight (kilograms) after addition of a second-line oral diabetes drug to metformin monotherapy. Randomized trials of these scenarios were systematically identified. The models were used to simulate each trial, and simulated and actual results were compared by linear regression and meta-analysis.

Results

Thirty-two randomized trials of second-line diabetes oral therapy were identified. For all outcomes and drugs studied, simulation and actual results correlated (P < 0.001).

SUBMITTER: Flory JH 

PROVIDER: S-EPMC4349393 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature