Distance from Glycemic Target at the Time of Add-On Initiation in Patients with Type 2 Diabetes (T2D) Failing Metformin Monotherapy in the United States

While it is known that a substantial proportion of U.S. patients with T2D are not at glycemic target, the distance to glycemic target has not been adequately characterized, especially at the time of add-on initiation. The objective of the study was to quantify the distance from an HbA1c target of 7% among patients failing metformin monotherapy at the time of treatment intensification with an add-on agent. This retrospective study using Quintiles Electronic Medical Record database included patients with diagnosed T2DM on metformin monotherapy between Jan 2012- Dec 2014 (index date), with at least 12 months of continuous enrollment pre-index date, documented HbA1c ≥7% and prescribed an add-on agent. Patients with type 1 diabetes, pregnancy/gestational diabetes or other secondary diabetes were excluded. Distance from glycemic target was calculated as the median difference of HbA1c from target of 7% at the time of add-on initiation was reported. A total of 22,239 T2DM patients met the study criteria; mean age of 58.3 years, 51.2% were female, 10.8% of patients had a history of microvascular complications; 5.1% had a history of macrovascular complications. Median difference from HbA1c target was 1.3%, with 23.7% (n=5261) of patients between 1 to 2%, and 35.5% (n=7897) greater than 2% from HbA1c target of 7%. In a sensitivity analysis that excluded patients for whom HbA1c target higher than 7% may be more appropriate (older patients ≥75 years, those with chronic diabetes complications or history of hypoglycemia; n = 5195) this distance to goal was still as high as 1.4%. In these patients, where a target of 8% may be more appropriate, 27.0% were ≥1% away from the target at the time of intensification. In this study, we found more than half of the metformin monotherapy patients were at least 1% away from glycemic target of 7% at the time of add-on initiation.