Proof-of-concept study to assess impact of glycemic variability
Jeffrey L. Probstfield, M.D., from the University of Washington in Seattle, and colleagues enrolled patients with insulin-requiring type 2 diabetes and high cardiovascular risk during a run-in period on basal bolus insulin (BBI). In an effort to maintain hemoglobin A1c (HbA1c) levels between 6.7 and 7.3 percent, 102 patients were randomly allocated to continue BBI or to basal insulin with a prandial GLP-1 receptor agonist for six months. The primary outcome was glycemic variability, assessed by continuous glucose monitoring.
The researchers note that the mean age of the population was 62 years at randomization, with median diabetes duration of 16 years. Participants had a mean body mass index of 34 kg/m² and HbA1c of 7.9 percent. Of the patients, 32, 18, and 3 percent had a prior cardiovascular event, microalbuminuria, and macroalbuminuria, respectively. Between the groups, the continuous glucose monitoring coefficient of variation for glucose levels was similar at baseline.
"We successfully randomized a population that has sufficient power to answer the primary question, address several secondary ones, and complete the protocol as designed," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Sanofi, which is primarily funding the trial. Several pharmaceutical companies have providing study funding and/or in-kind donations for the study.
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