Real-life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Galvus. The results of indirect analysis #1 are in the following table: Mean change in HbA1c: Indirect comparison of vildagliptin 50 mg once daily versus sitagliptin using placebo as common comparator (background metformin therapy). Biocon responded that it did respect “valid” intellectual property in India and that it had not “launched the product in India.” It also said it has yet to see an injunction from the court. Meta-analyses were conducted for HbA1c, weight, fasting plasma glucose (FPG), hypoglycaemia and other adverse events. Monotherapy with vildagliptin 50 mg once or twice daily reduced glycosylated haemoglobin (HbA(1c)) from baseline to a significantly greater extent than placebo, according to the results of 12- to 52-week trials in patients with type 2 diabetes. All these responses are important in patients with T2DM.
The adjusted mean change from baseline to endpoint (AMDelta) in HbA(1c) was -0.5 +/- 0.1% and -0.2 +/- 0.1% in patients receiving vildagliptin or placebo, respectively, with a significant between-treatment difference (p = 0.01). The mean age of the patients when enrolled into the study (vildagliptin group vs control group) was 59.5 ± 10.6 vs 63.7 ± 8.5 years, mean body mass index was 32.4 ± 5.7 vs 31.7 ± 6.5 kg/m2, mean HbA1c was 62 ± 12 vs 64 ± 11 mmol/mol. The exposure-adjusted incidences of each component of the composite endpoint for vildagliptin 50 mg bid were also lower than or similar to those of all comparators. Merck is the fourth-largest U.S. 19.8 mg/dl)].