In a nutshell
This study evaluated the effectiveness and safety of adding vildagliptin (Galvus, Zomelis, Jalra) to a metformin (Glucophage) and sulfonylurea (Amaryl, DiaBeta) combination in patients with type 2 diabetes.
Some background
Type 2 diabetes is a chronic progressive disease that occurs due to resistance to insulin. There are several drugs used to treat this disease and to slow down its progression, out of which the most widely used is metformin. Metformin is often combined with a sulfonylurea in an effort to control blood glucose. However, this combination may fail with time, requiring the addition of a third drug.
Vildagliptin is an oral drug that enhances insulin secretion. In previous studies it has proven to be effective when added to metformin, resulting in reduced hypoglycemia (dangerously low levels of blood glucose) risk and no weight gain.
Methods & findings
The authors aimed to evaluate the effectiveness of adding vildagliptin to metformin and sulfonylurea combination therapy. The study evaluated at 318 patients who were already taking a metformin and sulfonylurea combination; 158 were administered vildagliptin for 24 weeks, and 160 were administered a placebo (a substance without a therapeutic effect). Patients had been taking oral antidiabetic drugs for at least 12 weeks without effective control of their blood glucose. The study compared the patients’ HbA1c values (a measurement of average blood glucose levels over the past 3 months) at the beginning and end of the study.
After 24 weeks, the average reduction in blood glucose levels was 1.01% for vildagliptin and 0.25% for placebo. It was found that a significantly higher number of patients taking vildagliptin (28.3%) had achieved the target blood glucose level of <7% compared to the placebo group (5.6%). Vildagliptin also reduced the fasting blood glucose (glucose levels after receiving no food for 8 hours) by 1.11 mmol/L compared to nearly no change in the placebo group. The study also found that the safety of vildagliptin was similar to placebo when used in combination with metformin and a sulfonylurea, with 5.1% of vildagliptin patients experiencing hypoglycemia compared to 1.9% of placebo patients.
The bottom line
The study concluded that vildagliptin allowed more patients to achieve their target blood glucose and also reduced the fasting blood glucose compared to the placebo group.
The fine print
The study took place over a relatively short period of time. Long term use of vildagliptin and any associated adverse effects are still unknown.
What’s next?
If having difficulty controlling your blood glucose levels with metformin and a sulfonylurea, discuss the addition of vildagliptin with your doctor.
Published By :
Diabetes, Obesity and Metabolism
Date :
Nov 06, 2013