Real-world clinical responses in patients with type 2 diabetes mellitus adding exenatide BID (EBID) or mealtime insulin to basal insulin: a retrospective study using electronic medical record data

Abstract

Aim: Exenatide twice daily (EBID) and mealtime insulin are effective add-on therapies to basal insulin for type 2 diabetes patients in clinical trials. This study used electronic medical record (EMR) data to evaluate analogous real-world clinical responses.

Materials and methods: Adult patients initiating EBID or mealtime insulin as add-on to basal insulin during January 2008–March 2013 were identified in a US EMR database. EBID patients were propensity score matched 1:1 to mealtime insulin patients. Cohorts were followed for 12 months before (baseline) and 6 months after the index. A1C, hypoglycemic events, change in weight, and other clinical measures were evaluated by A1C attainment level (<6.5, < 7, < 7.5, <8, <9%) and baseline A1C.

Results: In total, 1249 EBID patients were matched to 1249 mealtime insulin patients. During follow-up, the percentage reaching A1C levels was similar for EBID vs mealtime insulin cohorts for all attainment levels (<7%: 27.8% vs 24.2%; < 9%: 79.7% vs 79.2%; p = NS). The percentage reaching A1C < 7% was similar for both cohorts with different baseline A1C. EBID patients had less hypoglycemia at all attainment levels (3.1% vs 11.1% [<6.5%]; 2.5% vs 4.7% [<9%]; all p < .03) and more weight loss (–9.0 vs –3.2 lb [<6.5%]; –3.4 vs +0.8 lb [<9%]; all p < .01).

Conclusions: EBID added to basal insulin was as effective in a real-world setting as mealtime insulin added to basal insulin in reducing A1C, with less weight gain and less hypoglycemia for a wide range of A1C attainment levels and baseline values.

Keywords:

• Exenatide
• basal insulin
• mealtime insulin
• electronic medical record data

Transparency

Declaration of funding

This study was funded by AstraZeneca.

Declaration of financial/other interests

H.N. was an employee of AstraZeneca at the time of this study. H.H., E.B. (at the time of this study), and K.L. are employees of IQVIA and were contracted to conduct this study by AstraZeneca. P.L. is a practicing endocrinologist and a consultant for AstraZeneca. A CMRO peer reviewer on this manuscript has been involved in clinical studies with exenatide and is a member of advisory boards of the following companies: AstraZeneca, Boehringer Ingelheim, Lilly, MSD, NovoNordisk, and Novartis. All other CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentations

The work was previously presented as the following two posters: (1) Poster titled “Real-World Treatment Responses from Electronic Medical Record (EMR) Data among Patients with Type 2 Diabetes (T2D) Receiving Basal Insulin either with Mealtime Insulin or Exenatide BID, by A1C Attainment Level and Baseline A1C” at the 76th Scientific Sessions of American Diabetes Association, June 10–14, 2016 in New Orleans, LA; and (2) Poster titled “Outcomes among Patients with Type 2 Diabetes Mellitus Receiving Basal Insulin with Mealtime Insulin or Exenatide BID: A Retrospective Study Using Real-World EMR Data” at the 75th Scientific Sessions of American Diabetes Association, June 5–9, 2015, in Boston, MA.

Acknowledgments

The authors thank Micah Amdur-Clark, employee of IQVIA at the time of this study, for help in preparing the manuscript.