Safety Comparison of Linagliptin and Glimepiride in Type 2 Diabetes Patients
Type 2 diabetes or diabetes mellitus, in 2008, affected almost 350 million people globally. China and India alone account for nearly 140 million patients. Generally treatment of type 2 diabetes begins with oral metformin and is often followed by the addition of a sulphonylurea to treatment regimen for achieving sustainable glycemic control. However, hypoglycemia and increased weight are accompanying side-effects of this combination therapy. The current study compares lasting efficacy and safety of linagliptin, a dipeptidyl peptidase-4 inhibitor, with glimepiride which is a sulphonylurea.
One of the major advantages of linagliptin is that it works in a blood glucose-dependent manner, i.e. it releases insulin from the pancreas when the blood sugar is high and insulin is needed. On the other hand, sulfonylureas (glimepiride) release insulin from the pancreas independent of blood sugar level. Therefore, using sulfonylureas exposes the patients to risks of hypoglycemia.
The clinical trial was conducted at 209 sites, across 16 countries, for 104 weeks in type 2 diabetes patients aged 18-80 years. The enrolled patients were receiving ≥1500 mg/day metformin with another oral anti-diabetic drug such as 5 mg linagliptin (777 patients) or 1-4 mg glimepiride (775 patients) once-a-day. The alterations in glycated hemoglobin A1c (HbA1c) levels were the primary endpoint, measured from baseline to week 104.
Declines in average HbA1c was comparable in linagliptin (-0·16%) and glimepiride groups (-0·36%), but the overall incidence of any drug-related adverse events was lower in patients treated with linagliptin.Fewer linagliptin-treated patients had hypoglycaemia (7%) and cardiac episodes (12) as compared with glimepiride-treated patients (36% and 26). Severe hypoglycemia was reported in 1 linagliptin patient as compared to 12 glimepiride patients. Weight gain reduced in the linagliptin group (-1·4 kg) but rose in glimepiride group (1·3 kg).
Thus linagliptin is as efficacious as, but safer than, glimepiride as a treatment choice for type 2 diabetes mellitus patients for whom metformin monotherapy is inadequate. The linagliptin plus metformin combination therapy should be considered in type 2 diabetes treatment.
2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomized, double-blind, non-inferiority trial; Baptist Gallwitz et al; The Lancet Online Publication 2012