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DOI: 10.2337/dc06-1815
© 2007 by the American Diabetes Association
Clinical Care/Education/Nutrition |
Comparison of Vildagliptin and Rosiglitazone Monotherapy in Patients With Type 2 Diabetes
A 24-week, double-blind, randomized trial
1 Dallas Diabetes and Endocrine Center, Dallas, Texas
2 Novartis Pharmaceuticals, East Hanover, New Jersey
3 Novartis Pharma AG, Basel, Switzerland
Address correspondence and reprint requests to Julio Rosenstock, MD, Dallas Diabetes and Endocrine Center at Medical City, 7777 Forest Ln., C-618, Dallas, TX 75230. E-mail: juliorosenstock{at}dallasdiabetes.com
OBJECTIVE—To compare the efficacy and tolerability of vildagliptin and rosiglitazone during a 24-week treatment in drug-naïve patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS—This was a double-blind, randomized, active-controlled, parallel-group, multicenter study of 24-week treatment with vildagliptin (100 mg daily, given as equally divided doses; n = 519) or rosiglitazone (8 mg daily, given as a once-daily dose; n = 267).
RESULTS—Monotherapy with vildagliptin and rosiglitazone decreased A1C (baseline = 8.7%) to a similar extent during the 24-week treatment, with most of the A1C reduction achieved by weeks 12 and 16, respectively. At end point, vildagliptin was as effective as rosiglitazone, improving A1C by –1.1 ± 0.1% (P < 0.001) and –1.3 ± 0.1% (P < 0.001), respectively, meeting the statistical criterion for noninferiority (upper-limit 95% CI for between-treatment difference 
0.4%). Fasting plasma glucose decreased more with rosiglitazone (–2.3 mmol/l) than with vildagliptin (–1.3 mmol/l). Body weight did not change in vildagliptin-treated patients (–0.3 ± 0.2 kg) but increased in rosiglitazone-treated patients (+1.6 ± 0.3 kg, P < 0.001 vs. vildagliptin). 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 proportion of patients experiencing an adverse event was 61.4 vs. 64.0% in patients receiving vildagliptin and rosiglitazone, respectively. Only one mild hypoglycemic episode was experienced by one patient in each treatment group, while the incidence of edema was greater with rosiglitazone (4.1%) than vildagliptin (2.1%).
CONCLUSIONS—Vildagliptin is an effective and well-tolerated treatment option in patients with type 2 diabetes, demonstrating similar glycemic reductions as rosiglitazone but without weight gain.
Abbreviations: DPP-4, dipeptidyl peptidase IV • FPG, fasting plasma glucose • GLP, glucagon-like peptide • ITT, intention to treat • TZD, thiazolidinedione
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