Galvus (vildagliptin) and Eucreas (vildagliptin and metformin)
Galvus (vildagliptin) and Eucreas (vildagliptin and metformin) are two new drugs approved for combination therapy with either metformin, sulfonylurine substances or glitazones of type 2 diabetes. Eucreas is a combination drug consisting of 850 – 1000 mg metformin and 50 mg of the DPP-4 inhibitor vildagliptin, while Galvus consists of 50 mg vildagliptin.
Three randomized double-blinded active– and placebo-controlled studies had a combination of vildagliptin and either metformin, glimepiride or pioglitazones ability in lowering HvA1c, compared to monotherapy with one of the three substances, as primary objective. They included patients which all were in treatment for diabetes mellitus, but had a poor glycaemia control. The studies lasted for 24 weeks and the difference in fall of HbA1c values between combinational treatment and the monotherapy were for the metformin combination: -1,10 ± 0,14 % with a 95 % confidence interval at [-1,37;0,84]. Combination with glimepiride gave at difference in -0,64 ± 0,13 % with a 95 % confidence interval at [-0,90;0,39], while the pioglitazon combination gave a difference at -0,67 ± 0,14 % with a 95 % confidence interval at [-0,94;0,40]. In the treatment with vildagliptin the side effects were at placebo level.
Galvus and Eucreas costs 17 – 18 Dkr pr. DDD, compared to the DPP-4 inhibitor sitagliptin (Januvia) which costs 17 – 18 Dkr pr. DDD.
There are no evidence that vildagliptin has an effect on mortality or morbidity. IRF states that vildagliptin can be used for patients with type 2 diabetes that are insufficiently hypoglycaemically controlled on treatment with metformin, and who does not have any advantage in extra treatment with - or experiences hypoglycaemic incidences with – SU. There has not been carried out any direct comparator studies with sitagliptin (Januvia), while extensive amount of evidence for the HbA1c lowering effect of vildagliptin are available.
Galvuis and Eucreas were marketed the 5th of May 2008, and are under the rules of general reimbursement.