Purpose: This is a pre-post observational study from an endocrinology ambulatory care practice assessing the effectiveness and safety of a single injectable combination antidiabetic agent, the basal insulin, insulin glargine, and the glucagon-like peptide-1 (GLP-1) receptor agonist, lixisenatide, to background therapy for patients with type 2 diabetes mellitus (T2DM).
Methods: The study population will consist of subjects with T2DM who have failed to achieve adequate glycemic control and require the addition of once-daily insulin glargine-lixisenatide (iGlarLixi). Five groups will be assessed: patients initiating iGlarLixi, patients on a basal insulin at baseline, patients on a GLP-1 receptor agonist at baseline, patients on basal insulin and GLP-1 receptor agonist (single-entity products) at baseline and patients only on oral antidiabetic agents at baseline. Potential subjects will be identified via a computerized text search of medication lists from patients’ electronic medical records, which will be reviewed to ascertain if study criteria are met.
Outcome:The primary study outcome is change in HbA1c. Secondary outcomes include percentage of patients achieving an HbA1c of < 7% or ≤ 6.5%, change in weight, change in systolic and diastolic blood pressures and change in lipid parameters. Safety will be assessed via collection of reported adverse effects.
Results: Thirty subjects initiated therapy with iGlarLixi and 23 had follow-up data. The mean duration of T2DM was 11.3 years and baseline HbA1c was 8.27%. The median starting dose of iGlarLixi was 30 units and the mean dose at follow-up was 41 units. After an average of about 4 months on therapy, HbA1c decreased by 0.94% in the entire cohort (p = 0.02). Fifty-seven percent of subjects achieved an HbA1c < 7% and 26% achieved an HbA1c ≤ 6.5%. iGlarLixi was well tolerated and discontinuation was low (3 subjects) and mainly due to medication cost.
M.D. Stryker: Other Relationship; Self; Amgen Inc.. Research Support; Self; AstraZeneca. Other Relationship; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Regeneron Pharmaceuticals, Inc.. C.A. Blow: None. E.B. Friedman: None. R.S. Busch: Speaker's Bureau; Self; AbbVie Inc., AstraZeneca. Research Support; Self; Bayer AG, Intarcia Therapeutics, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Amgen Inc.. Research Support; Self; Sanofi US. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Amarin Corporation. M.P. Kane: None.