TY - JOUR
T1 - Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin
AU - Bosi, Emanuele
AU - Camisasca, Riccardo Paolo
AU - Collober, Carole
AU - Rochotte, Erika
AU - Garber, Alan J.
PY - 2007/4
Y1 - 2007/4
N2 - OBJECTIVE - We sought to evaluate the efficacy and safety of vildagliptin, a new dipeptidyl peptidase-4 inhibitor, added to metformin during 24 weeks of treatment in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS - This was a double-blind, randomized, multicenter, parallel group study of a 24-week treatment with 50 mg vildagliptin daily (n = 177), 100 mg vildagliptin daily (n = 185), or placebo (n = 182) in patients continuing a stable metformin dose regimen (≥1,500 mg/day) but achieving inadequate glycemic control (A1C 7.5-11%). RESULTS - The between-treatment difference (vildagliptin - placebo) in adjusted mean change (AMΔ) ± SE in A1C from baseline to end point was -0.7 ± 0.1% (P <0.001) and -1.1 ± 0.1% (P <0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. The between-treatment difference in the AMΔ fasting plasma glucose (FPG) was -0.8 ± 0.3 mmol/l (P = 0.003) and -1.7 ± 0.3 mmol/l (P <0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. Adverse events (AEs) were reported by 63.3, 65.0, and 63.5% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. Gastrointestinal AEs were reported by 9.6 (P = 0.022 vs. placebo), 14.8, and 18.2% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. One patient in each treatment group experienced one mild hypoglycemic event. CONCLUSIONS - Vildagliptin is well tolerated and produces clinically meaningful, doserelated decreases in A1C and FPG as add-on therapy in patients with type 2 diabetes inadequately controlled by metformin.
AB - OBJECTIVE - We sought to evaluate the efficacy and safety of vildagliptin, a new dipeptidyl peptidase-4 inhibitor, added to metformin during 24 weeks of treatment in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS - This was a double-blind, randomized, multicenter, parallel group study of a 24-week treatment with 50 mg vildagliptin daily (n = 177), 100 mg vildagliptin daily (n = 185), or placebo (n = 182) in patients continuing a stable metformin dose regimen (≥1,500 mg/day) but achieving inadequate glycemic control (A1C 7.5-11%). RESULTS - The between-treatment difference (vildagliptin - placebo) in adjusted mean change (AMΔ) ± SE in A1C from baseline to end point was -0.7 ± 0.1% (P <0.001) and -1.1 ± 0.1% (P <0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. The between-treatment difference in the AMΔ fasting plasma glucose (FPG) was -0.8 ± 0.3 mmol/l (P = 0.003) and -1.7 ± 0.3 mmol/l (P <0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. Adverse events (AEs) were reported by 63.3, 65.0, and 63.5% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. Gastrointestinal AEs were reported by 9.6 (P = 0.022 vs. placebo), 14.8, and 18.2% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. One patient in each treatment group experienced one mild hypoglycemic event. CONCLUSIONS - Vildagliptin is well tolerated and produces clinically meaningful, doserelated decreases in A1C and FPG as add-on therapy in patients with type 2 diabetes inadequately controlled by metformin.
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U2 - 10.2337/dc06-1732
DO - 10.2337/dc06-1732
M3 - Article
C2 - 17277036
AN - SCOPUS:34147093268
VL - 30
SP - 890
EP - 895
JO - Diabetes Care
JF - Diabetes Care
SN - 1935-5548
IS - 4
ER -