Influence of Treatment Intensification on A1c in Patients with Suboptimally Controlled Type 2 Diabetes After 2 Oral Antidiabetic Agents.

Background: In the United States, more than 50% of patients with type 2 diabetes mellitus (T2DM) have hemoglobin A1c (A1c) levels that fail to achieve the recommended target of < 7.0%. Of these, 30%-45% have an A1c > 9.0%, the threshold for poorly controlled T2DM per National Committee for Quality Assurance (NCQA) measures. Treatment inertia is a known challenge. However, recent treatment intensification patterns and outcomes after treatment fails 2 classes of oral antidiabetic agents (OADs) are not well understood.

Objective: To characterize treatment intensification patterns and glycemic control outcomes in patients with A1c ≥ 7.0% on 2 OADs.

Methods: A retrospective cohort study was conducted in patients with T2DM from a regional health plan claims dataset augmented with A1c results between January 1, 2010, and March 31, 2017. Patients were identified with an A1c ≥ 7.0% (baseline), while on 2 OADs, and whose treatment was intensified with basal/biphasic insulin (insulin), glucagon-like peptide-1 receptor antagonist (GLP-1RA), or a third OAD within 365 days after the baseline A1c ≥ 7.0%. Patients had at least 1 A1c value 60-365 days (follow-up period) after treatment intensification. The proportion of patients with an A1c < 7.0% and < 9.0% at follow-up were identified by therapeutic intensification strategy. Odds ratios for achieving A1c < 7.0% and < 9.0% were calculated.

Results: 1,226 patients were included in the analysis, and 33.5% of the patients had a baseline A1c ≥ 9.0%. 24% of patients received insulin; 16% received GLP-1RA; and 60% received a third OAD for the treatment intensification. Overall, 26.0% achieved A1c < 7.0% and 76.1% of patients achieved < 9.0%, with a median follow-up of 119 days. The proportion of patients intensified with insulin who had an A1c ≥ 9.0% at follow-up was 34.6% versus 53.2% at baseline (P < 0.01). The corresponding percentages for those intensified with a GLP-1RA and OAD were 21.6% versus 27.1% (P = 0.24) and 20.1% versus 27.3% (P < 0.01). After controlling for baseline characteristics, the odds ratio (95% CI) of achieving A1c < 7.0% and < 9.0% was 2.05 (1.45-2.90) for GLP-1RA and 0.92 (0.61-1.40) for OAD. The association between goal attainment and GLP-1RA versus OAD intensification was influenced by the time to the A1c follow-up and baseline A1c.

Conclusions: Treatment intensification was associated with improved glycemic control in patients after therapy failed 2 OADs. Patients with higher A1c at baseline were likely to initiate insulin, which was associated with a greater drop in A1c. GLP-1RA was associated with a higher likelihood of achieving NCQA-suggested glycemic control compared with a third OAD. However, the association varied by the follow-up period. These findings are important to health plans seeking to improve patient outcomes as reflected in high performance on NCQA diabetes quality measures by promoting effective and timely treatment intensification.

Disclosures: Research funding was provided by Sanofi to the Pharmacotherapy Outcomes Research Center at the University of Utah and SelectHealth to conduct this study. Thomas, Sterling, and Johnstone are employees and stock/shareholders of Sanofi. Kim, Unni, McAdam-Marx, and Brixner are employees of the Department of Pharmacotherapy at the University of Utah. Brixner also has served as an advisory board member and presenter for Sanofi. McAdam-Marx also reports grants to the Department of Pharmacotherapy, University of Utah, from AstraZeneca and Janssen, outside of the submitted work. Olsen is employed by SelectHealth. Part of the results of this study was presented at the Academy of Managed Care & Specialty Pharmacy Annual Meeting 2018 in Boston, MA, during April 23-26, 2018.