Galvus

Novartis has launched a new oral hypoglycaemic for the treatment type II diabetes.

PHARMACOLOGY
Vildagliptin is one of a new class of oral hypoglycaemics known as dipeptidyl peptidase 4 (DPP-4) inhibitors. The drug enhances pancreatic islet function by increasing endogenous levels of incretin hormones thereby improving both alpha and beta cell sensitivity to glucose and resulting in more glucose-appropriate glucagon secretion and improved glucose-dependent insulin secretion.1

 

CLINICAL STUDIES
In clinical studies involving 5,759 patients with type II diabetes enrolled in 13 clinical trials each lasting at least 12 weeks vildagliptin was found to improve glycaemic control when given as monotherapy or when used in combination with metformin, a sulphonylurea or a glitazone, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint.1The magnitude of reduction in HbA1c was greater in patients with higher baseline HbA1c.1

The use of vildagliptin as add-on therapy in patients inadequately controlled by metformin alone was evaluated in a 24-week randomised controlled trial involving 544 patients with type II diabetes.2 Patients were randomised to receive vildagliptin 50mg daily, 100mg daily (in two divided doses) or placebo in addition to a stable regimen of metformin >1500mg daily. A clinically significant and dose-related decrease in fasting plasma glucose and HbA1c was observed in both vildagliptin groups with no weight gain and no increase in the incidence of hypoglycaemia.

In another 24-week study, vildagliptin as add-on therapy to metformin in patients inadequately controlled on metformin alone (vildagliptin 100mg daily in two divided doses, n=295) was found to be non-inferior to add-on pioglitazone (30mg once daily, n=281) but without the associated weight gain.3 The frequency of other adverse effects was similar in the two treatment groups.

In a placebo-controlled study involving patients inadequately controlled on glitazone monotherapy (n=463) the addition of vildagliptin (50 or 100mg daily) to pioglitazone (45mg daily) was effective and well tolerated with no increase in the risk of hypoglycaemia.4

 

REFERENCES
1. Galvus Summary of Product Characteristics. January 2008
2. Bosi E, Camisasca R, Collober C et al. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care 2007; 30: 890–895.
3. Bolli G, Dotta F, Rochotte E et al. Efficacy and tolerability of vildagliptin vs. pioglitazone when added to metformin:
a 24-week, randomized, double-blind study. Diabetes Obes Metab 2008; 10: 82–90.
4. Garber A, Schweizer A, Baron M et al. Vildagliptin in combination with pioglitazone improves glycaemic control in
patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab 2007; 9: 166–174.

 

View Galvus drug record

Further information: Novartis


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