Using Exenatide Twice Daily or Insulin in Clinical Practice: Results from CHOICE

Abstract

Introduction: CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy; NCT00635492) assessed, as its primary objective, the time to a 'significant treatment change' (defined within this paper) after patients with type 2 diabetes mellitus initiated their first injectable, glucose-lowering therapy [exenatide twice daily (BID) or insulin] in clinical practice in six European countries and evaluated outcomes during the study.

Methods: CHOICE was a 24-month, prospective, noninterventional observational study. Patients were invited to participate in CHOICE only after their treating physician had made the clinical decision to initiate first injectable therapy with either exenatide BID or insulin. Clinical data were collected at initiation of first injectable therapy and after approximately 3, 6, 12, 18, and 24 months.

Results: A total of 2,515 patients were recruited; 1,114 patients in the exenatide BID cohort and 1,274 patients in the insulin cohort were eligible for the 24-month analysis. During the study, 42.2% and 36.0% of patients from each cohort, respectively, had a significant treatment change. By 24 months, improved mean glycated hemoglobin (p < 0.001 for both cohorts) and reduced severity of several cardiovascular risk factors were observed in both cohorts; additionally, mean weight was reduced in the exenatide BID cohort (p < 0.001) and increased in the insulin cohort (p < 0.001). Hypoglycemia was reported by 18.4% of the exenatide BID cohort and 36.8% of the insulin cohort; 25.9% of the exenatide BID cohort and 10.0% of the insulin cohort had met the secondary endpoint of glycated hemoglobin <7.0%, no weight gain, and no hypoglycemia.

Conclusion: CHOICE provided data on exenatide BID and insulin usage patterns and 24-month outcomes in clinical practice. On average, improved glycemic control and reduced severity of cardiovascular risk factors were observed in both cohorts, and those in the exenatide BID cohort also had mean weight loss.

Fig. 1

Study disposition at 24 months. BID twice daily, DDP-IV dipeptidyl peptidase-IV, GLP-1 glucagon-like peptide-1, OAD oral antidiabetes drug

Fig. 2

Kaplan–Meier estimates for time until significant treatment change after initiation of injectable therapy with exenatide BID or insulin. BID twice daily

Fig. 3

First significant treatment change (using the primary definition) occurring during the 24 months following initiation of insulin in patients with T2DM according to baseline insulin regimen (the ‘other’ category comprised combinations of a ‘mixture’ with either a ‘short-acting’ or ‘long-acting’ insulin). T2DM type 2 diabetes mellitus

Fig. 4

Proportion of patients with T2DM reporting hypoglycemia per 6-month period in the exenatide BID (E) and insulin (I) cohorts, overall and according to use of SUs; initiators analysis. SU use was defined as any use of SU during the study, irrespective of whether use was interrupted or discontinued. BID twice daily, SU sulfonylurea, T2DM type 2 diabetes mellitus