Galvus Meets Not Inferior-to-Avandia Standard

February 16, 2007

DALLAS -- Galvus (vidagliptin), an investigational oral dipeptidyl peptidase IV-blocker (DPP-4) for type 2 diabetes, was as effective as a rosiglitazone at glycemic control, without associated weight gain, reported researchers here.

DALLAS, Feb. 16 -- Galvus (vidagliptin), an investigational oral dipeptidyl peptidase IV-blocker (DPP-4) for type 2 diabetes, was as effective as Avandia (rosiglitazone) at glycemic control, but without the latter drug's associated weight gain, reported researchers here.

In a 24-week comparison trial, both drugs were effective as monotherapy at decreasing hemoglobin A1c (HbA1c) levels, but patients taking Avandia gained weight while those randomized to Galvus did not, reported Julio Rosenstock, M.D., of the Dallas Diabetes and Endocrine Center here.

Galvus was associated with decreased triglyceride and LDL levels, but with a lower increase in HDL levels than Avandia, the investigators reported in the February issue of Diabetes Care. The study was funded by Novartis, maker of Galvus.

Galvus has been shown in 12-week studies to decrease HbA1c when given as either monotherapy or in combination with Glucophage (metformin).

The study compared the efficacy and tolerability of Galvus and Avandia in double-randomized, parallel-group study. A total of 519 treatment-nave patients received Galvus at 100 mg daily given as equally divided doses, and 267 received Avanida at 8 mg once daily.

The authors found that both drugs reduced HbA1c levels significantly from baselines (mean 8.7% in each group), with Avandia having a slight but not significant edge. In an intention-to-treat analysis, Avandia reduced HbA1c at 24 weeks by -1.3 + 0.1% (P<0.001) compared with Galvus, which reduced levels by -1.1 + 0.1%.

Galvus met the statistical criterion for non-inferiority, the authors noted.

Avandia was significantly better at reducing fasting plasma glucose levels from baseline (mean of 10.3 mmol/l in both treatment groups). The adjusted mean change from baseline for Avandia was -2.3 + 0.2 mmol/l, and for Galvus was -1.3 + 0.1 mmol/l (P for comparison <0.001).

There were no body-weight changes in patients taking Galvus (mean -0.3 + 0.2 kg change from baseline). In comparison, patients on Avandia gained an average of 1.6 + 0.3 kg, P<0.001 over the 24 weeks of the study.

"Relative to rosiglitazone, vildagliptin significantly decreased triglycerides, total cholesterol, and LDL, non-HDL, and total-to-HDL cholesterol (-9 to -16%, all P < 0.01), but produced a smaller increase in HDL cholesterol (+4 vs. + 9%, P =0.003)," the authors noted.

Adverse events occurred in 61.4 of patients on Galvus, compared with 64.0% in patients on Avandia. The most common adverse events were nasopharyngitis, headache and dizziness.

The proportion of patients experiencing any serious adverse event in the two treatment groups was comparable (2.9% versus 3.0%), and no specific serious adverse event was reported by more than one patient within a treatment group.

One patient in each treatment group had one mild hypoglycemic episode. One death occurred, from postsurgical complications, during the study, in a 70-year-old man randomized to Galvus.

"Similar A1C efficacy can be achieved using the DPP-4 inhibitor vildagliptin or a thiazolidinedione as monotherapy in drug-nave patients with type 2 diabetes," the authors wrote. "Vildagliptin is well tolerated, and, despite the improvement in glycemic control, it does not cause weight gain, which is an important consideration in the decision-making process for selecting first-line therapy in type 2 diabetes."