OBJECTIVES: To assess prevalence and type of Patient-Reported Outcomes (PROs) in Type 2 Diabetes clinical trials.  METHODS: A search of www.clinicaltrials.gov was conducted using the search criteria of Type-2 diabetes (T2DM) as the disease and drug as the intervention, in addition to limiting the studies to Phase 3.  This resulted in 810 trials.  Trials were excluded if any of the following exclusion criteria were met: sample size <50, start date before 2000, main condition other than T2DM, and trial did not include clinical outcomes.  Phase 2/3 studies, pediatrics trials, and both double-blind and open-label studies were included.  The remaining 632 trials were then assessed for prevalence and type of PROs.  RESULTS: Only 47 (7.4%) of trials in the sample used PROs.  There is no discernable trend for PRO use over time.  For these 47 trials, 1.9 PROs were used on average, with a range of 1 to 7 PROs.  A total of 90 PROs were included in these 47 trials.  Forty-three (48%) of these PROs measured Health-Related Quality of Life (HRQL)/Utilities, 22 (24%) measured treatment satisfaction, five (6%) were unknown. Within the HRQL measures, 37% (16) were diabetes-specific, 37% (16) were generic (e.g., SF-36), and the remaining 26% of PROs were not specified.  Among treatment satisfaction, 82% were diabetes-specific.  Thirty-three (70%) of the studies using PROs were for drugs that are injectables (i.e., not oral).  CONCLUSIONS:  PRO use in T2DM clinical trials remains low. Despite their underuse, the need to assess effectiveness of an intervention from a patient perspective continues to grow in relevance.  Although there are a host of diabetes-specific PROs available, the development of a clinical trial-specific, user-friendly instrument may be needed given the increase in medicines, especially injectables, coming to market in the future.