Glycemic control over 5 years in 4,900 people with type 2 diabetes: real-world diabetes therapy in a clinical trial cohort

Best JD, Drury PL, Davis TM, Taskinen MR, Kesäniemi YA, Scott R, Pardy C, Voysey M, Keech AC; on behalf of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study investigators.
Diabetes Care. 2012 Mar 19. Epub ahead of print. 

OBJECTIVE Glycemic control in type 2 diabetes generally worsens over time, requiring intensification of therapy. The Fenofibrate Intervention and Event Lowering in Diabetes trial provided the opportunity to observe glycemic control in a real-world setting. We assessed the adequacy of metformin, sulfonylureas, and insulin to maintain glycemic control and their effects on weight. 

RESEARCH DESIGN AND METHODS Diabetes control was measured at baseline and yearly for a median of 5 years in the 4,900 patients from the nonintervention arm of this study allocated to placebo.

RESULTS Median HbA(1c) was 6.9% at baseline and increased by an average of 0.22% over 5 years (P < 0.001). Median weight was 86.3 kg at baseline and decreased by 0.4 kg over 5 years (P = 0.002). Baseline therapy was lifestyle measures only in 27%, oral agents without insulin in 59%, and insulin in 14% (7% also taking oral agents). Over 5 years, insulin use increased to 32% (21% also taking oral agents). Use of oral agents remained similar at 56%. Only 2% of patients at baseline and 4% after 5 years were taking oral agents other than metformin or sulfonylureas. Initiation of insulin therapy in 855 patients produced a sustained reduction of HbA(1c) from a median of 8.2 to 7.7%, with a weight gain of 4.6 kg over 5 years.

CONCLUSIONS With intensification of traditional therapies, glycemic control deteriorated very little over 5 years in a large cohort of type 2 diabetes. However, the requirement for insulin therapy doubled, at the expense of significant weight gain and risk of hypoglycemia. 

 

Last Modified: 1/25/2013