Vildagliptin added to sulfonylurea improves glycemic control without hypoglycemia and weight gain in Chinese patients with type 2 diabetes mellitus

• Published in: Journal of diabetes 2015-03, Vol.7 (2), p.174-181
• Main Authors: Yang, Wenying, Xing, Xiaoping, Lv, Xiaofeng, Li, Yiming, Ma, Jianhua, Yuan, Guoyue, Sun, Feifei, Wang, Wei, Woloschak, Michael, Lukashevich, Valentina, Kozlovski, Plamen, Kothny, Wolfgang
• Format: Article
• Language: English
• Subjects: Adamantane - analogs & derivatives; Adamantane - therapeutic use; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose - analysis; Blood Glucose - drug effects; Case-Control Studies; China; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use; Double-Blind Method; Female; Follow-Up Studies; Glycated Hemoglobin A - metabolism; Glycemic Index; Humans; Hypoglycemia - prevention & control; Hypoglycemic Agents - therapeutic use; Male; Middle Aged; Nitriles - therapeutic use; Prognosis; Pyrrolidines - therapeutic use; Risk Factors; Sulfonylurea Compounds - therapeutic use; Weight Gain - drug effects; Young Adult
• ISSN: 1753-0407
• DOI: 10.1111/1753-0407.12169

The aim of the present study was to assess the efficacy and safety of vildagliptin as add-on to sulfonylurea therapy in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy. The 24-week randomized double-blind placebo-controlled study compared vildagliptin 50 mg, q.d., with placebo as add-on to glimepiride in T2DM patients who were inadequately controlled (HbA1c 7.5%-11.0% [58-97 mmol/mol]) on a stable dose of sulfonylurea for ≥12 weeks before study entry. In all, 279 patients were randomized to receive either vildagliptin (n = 143) or placebo (n = 136). At baseline, overall mean age was 58.5 years, body weight 68.1 kg, duration of diabetes 6.9 years and daily glimepiride dose 3.3 mg. After 24 weeks, the adjusted mean change (AMΔ) in HbA1c was -0.7% (-8 mmol/mol; baseline 8.6%, 70 mmol/mol) in the vildagliptin group and -0.2% (-2 mmol/mol; baseline 8.7%, 72 mmol/mol) in the placebo group, with a treatment difference of -0.5% (-5 mmol/mol; P