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- Title
Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial – a primary care, type 2 diabetes study.
- Authors
Blonde, L.; Dagogo-Jack, S.; Banerji, M. A.; Pratley, R. E.; Marcellari, A.; Braceras, R.; Purkayastha, D.; Baron, M.
- Abstract
Aim: To assess the efficacy and tolerability of vildagliptin compared with thiazolidinediones (TZDs) as an add on to metformin treatment in a primary care patient population with type 2 diabetes. Methods: This was a randomized, 12-week, open-label study comparing vildagliptin (100 mg, n = 1653) and TZD (agent and dose at the investigators’ discretion, n = 825) add-on therapy in patients inadequately controlled [haemoglobin A1C (HbA1c): 7–10%] on a stable dose of metformin (≥1000 mg/day). The primary objective was to test non-inferiority of vildagliptin to TZDs for the difference in change in HbA1c from baseline [established if the upper limit of the two-sided 95% confidence intervals (CI) did not exceed 0.4%]. Results: Mean (± s.e.) change in HbA1c from baseline to study endpoint was –0.68 ± 0.02% in the vildagliptin group and −0.57 ± 0.03% in the TZD group. The difference between groups was −0.11% (95% CI: −0.17% and −0.04%), establishing the non-inferiority of vildagliptin (p = 0.001) after 3 months of treatment. Vildagliptin was non-inferior to TZDs for subgroups of race, age and body mass index. Body weight increased in the TZD group (0.33 ± 0.11 kg) and decreased in the vildagliptin group (mean: −0.58 ± 0.09 kg; p < 0.001 for difference). Adverse events occurred in similar proportions of patients in both groups (vildagliptin: 39.5% and TZD: 36.3%) Hypoglycaemia and abnormal changes in liver enzymes were uncommon. Conclusions: This short-term study suggests that vildagliptin is as effective as TZDs after 3-month treatment as an add-on to metformin in a primary care population that included diverse patient subgroups.
- Subjects
DRUG efficacy; PRIMARY care; DRUG tolerance; PEOPLE with diabetes; METFORMIN; CONFIDENCE intervals
- Publication
Diabetes, Obesity & Metabolism, 2009, Vol 11, Issue 10, p978
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/j.1463-1326.2009.01080.x