Phase 3 trial demonstrates the safety and efficacy of albiglutide in type 2 diabetes patients with renal impairment….
Renal impairment is a common comorbid condition in type 2 diabetes patients with reported incidence rates as high as 35%. Those with renal insufficiency often find their diabetes treatment options limited. Possible options like insulin and sulfonylureas are associated with side effects such as weight gain and hypoglycemia.
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Albiglutide, approved by the FDA in April 2014, is a glucagon-like peptide 1 (GLP-1) receptor agonist. This medication has a half-life of about 5 days which allows for once weekly dosing. A previous phase I study showed the medication to be tolerable in renally impaired patients with type 2 diabetes.
Researchers compared the safety and efficacy of once-weekly albiglutide with daily sitagliptin in type 2 diabetes patients with renal insufficiency whose blood glucose was uncontrolled on current therapy. A total of 507 type 2 diabetes patients with a GFR of 15 to 90 mL/min/1.73 m2 were enrolled in this phase 3 trial. The participants were randomly assigned to receive either a weekly subcutaneous dose of albiglutide (30mg or 50mg) or daily oral sitagliptin (25-100mg depending on GFR). Each was also given a matching placebo. The primary outcome compared the efficacy of the two medications based on the change in HbA1c from baseline to week 26. Several secondary outcomes were also measured including fasting blood glucose and safety as measured by adverse event frequency.
Results showed the albiglutide group had a change from baseline to week 26 in HbA1c of -0.83% compared to -0.52% in the sitagliptin group. The treatment difference was -0.32% (95% CI -0.49, -0.15). This treatment effect was maintained upon trial completion at week 52. A change in fasting blood glucose was found to be significant in the albiglutide group when comparing the value to baseline at week 26 (P<0.0001). In terms of safety, albiglutide compared well to sitagliptin. Constipation and diarrhea were seen more commonly in the albiglutide group, but other GI events had similar rates of occurrence.
Results of this study show albiglutide as a possible option for type 2 diabetes patients with mild to moderate renal impairment. Decreases in both HbA1c and fasting blood glucose were observed over the 52 week course of the study. The side effect monitoring also showed that the medication was generally well tolerated in this population. Due to the small sample of patients with severe renal impairment (GFR of 15-29 mL/min/1.73 m2) in this study, further research is warranted before a recommendation can be given for this patient population.
- Albiglutide is a GLP-1 receptor agonist with an extended half-life which allows for a weekly administration via subcutaneous injection.
- Albiglutide showed HbA1c and fasting blood glucose reductions in this study with a side effect profile that was generally well tolerated.
Leiter LA et al. Efficacy and Safety of the Once-Weekly GLP-1 Receptor Agonist Albiglutide Versus Sitagliptin in Patients With Type 2 Diabetes and Renal Impairment: A Randomized
Phase III Study. Diabetes Care 2014; DOI: 10.2337/dc13-2855.