NEW YORK (Reuters Health) – The combination of the dipeptidyl peptidase (DPP)-4 inhibitor alogliptin and the thiazolidinedione pioglitazone effectively reduces HbA1c in patients with type 2 diabetes uncontrolled by diet and exercise, and a multicenter study shows.
The catch is that alogliptin is yet to be approved by the US Food and Drug Administration. Reports say that may not be until 2013.
Meanwhile, Dr. Julio Rosenstock with the Dallas Diabetes and Endocrine Center at Medical City, Texas, conducted a 26-week trial with 655 patients with type 2 diabetes who had not had prior drug treatment. They were randomly assigned to alogliptin 25 mg/d monotherapy, pioglitazone 30 mg/d monotherapy, or pioglitazone 30 mg/d in combination with alogliptin 12.5 mg/d or 25 mg/d.
The high-dose combination produced a significantly greater drop in HbA1c than either monotherapy, the investigators report in Diabetes Care published online August 19.
Specifically, HbA1c fell 0.96%, 1.15%, 1.56% and 1.71% in the four arms, respectively, from a mean baseline concentration of 8.88%.
“Despite a relatively high baseline HbA1c, this treatment strategy allowed nearly 2/3 of the patients to achieve HbA1c <\=7.0%,” Dr. Rosenstock and colleagues report.
Body weight did not change with alogliptin monotherapy, but increased by 2.2 to 3.1 kg in the three pioglitazone arms.
The incidence of drug-related adverse effects, such as headache, back pain, urinary tract infection and peripheral edema, ranged from 13.4% with alogliptin alone up to 21.3% with the high-dose combination.
No congestive heart failure events occurred, no bone fractures were reported, and hypoglycemia was uncommon, the team found.
They conclude, “Initial combination treatment with alogliptin and pioglitazone appears to be safe and was highly effective in short-term exposure, and may be considered as an initial therapeutic option for type 2 diabetes patients not achieving adequate glycemic control with lifestyle changes alone or in those who cannot tolerate metformin therapy.”
Initial Combination Therapy with Alogliptin and Pioglitazone in Drug-Naïve Patients With Type 2 Diabetes
Diabetes Care 2010.