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Exenatide Combined with Basal Insulin Improves Glycemic Control with Favorable Non-Glycemic Effects
Exenatide and basal insulin are commonly used to advance treatment of type 2 diabetes. While currently not indicated for combination treatment in type 2 diabetes mellitus (T2DM), data presented at the American Diabetes Association 70th Annual Scientific Sessions on June 26, 2010 examined the effects of combining exenatide with insulin therapy in patients with T2DM. A 30-week trial studied the addition of twice-daily exenatide to insulin glargine with or without other oral antidiabetic agents in 259 patients with longstanding T2DM (mean disease duration: 12 years). In this study, a greater percentage of the exenatide plus insulin glargine group achieved an A1C < 6.5% (49% vs. 14%) and a reduction in body weight (-1.8 kg vs. +1.0 kg) was observed with the exenatide/glargine combination vs. insulin glargine alone (Abstract 10-LB). Further, the rates of hypoglycemia rates were determined to be similar (1.4 vs. 1.2 episodes/person/year).
In another study, the effects of adding exenatide to an insulin glargine/metformin combination were reported for 38 T2DM patients with mean disease duration of 8.5 years(Abstract 18-LB). Median A1C at completion of the 24-week trial was 6.45% with the exenatide/glargine/metformin combination compared to 7.3% with glargine/metformin alone. Furthermore, the exenatide/glargine/metformin combination resulted in a greater proportion of patients achieving an A1C < 6.5% (47% vs. 24%) compared to glargine/metformin alone. Patients receiving the exenatide/glargine/metformin combination experienced significantly less weight gain study when compared to patients receiving glargine/metformin (0.4 kg vs. 4.1 kg). While minor hypoglycemia occurred in 53% of individuals treated with exenatide/glargine/metformin subjects compared to 41% of subjects receiving glargine/metformin, no occurrences of moderate or severe hypoglycemia were reported in either group.
The efficacy of insulin lispro protamine added to exenatide plus oral agents was compared to glargine over 24 weeks in a non-inferiority trial (Abstract 19-LB). In this study, both lispro and glargine added to exenatide resulted in a majority of patients achieving an A1C < 7% (53.7% vs. 61.7%) with similar rates of severe hypoglycemia (1.8% vs. 0%) and weight gain (+0.3 vs. +0.7 kg). A1C reduction was greater with insulin glargine (-1.4) compared to insulin lispro protamine (1.16). While these studies demonstrate that exenatide together with basal insulin therapy can be effective, exenatide is not currently FDA-approved for combination with insulin therapy.