• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials

• Endocrinology
• Diabetes & Metabolic Syndrome
• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials

The Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus (T2DM) study [ENDURE; NCT00856284] showed that there were greater reductions in the primary endpoint of least square mean change from baseline in HbA1C at 104 weeks with two doses of the DPP-4 inhibitor alogliptin compared with the sulfonylurea glipizide. Stefano Del Prato, MD, UOC Malattie Metaboliche e Diabetologia, Pisa, Italy, presented the results.

In this multicenter, double-blind, active-controlled study, patients whose T2DM was not controlled on a stable dose of metformin were randomized to one of three study arms: alogliptin 12.5 mg QD plus metformin 1500 to 3000 mg QD (ALO 12.5; n=880); alogliptin 25 mg QD plus metformin 1500 to 3000 mg QD (ALO 25; n=885); or glipizide 5 mg QD, titrated to 20 mg maximum, plus metformin 1500 to 3000 mg QD (GLIP; n=874) [Del Prato S et al. EASD 2013 (abstr 113)].

Most (62.3%) of the patients were white, 50.3% were women, and their mean age was 55.4 years. Body mass index was 31 kg/m², baseline HbA1C was 7.6%, and diabetes duration was 5.5 years. The changes achieved in the three treatment arms are shown in Table 1.

Safety was similar in the three treatment arms, with a similar number of adverse events (AEs), serious AEs, or AEs resulting in discontinuing treatment. Upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, and back pain were the most common AEs overall and in each treatment group. One patient in the ALO 25 and 3 in the GLIP arms had pancreatitis. A total of 11 patients died (3 in ALO 12.5; 3 in ALO 25; 5 in GLIP).

ENDURE demonstrated the sustained efficacy of alogliptin through 104 weeks of treatment, with significantly more patients taking the 25-mg dose achieving an HbA1C ≤7%, plus a lower rate of hypoglycemia with both doses compared with glipizide.

• © 2013 MD Conference Express®