In a nutshell
The aim of this study was to evaluate the efficacy and safety of exanatide compared to premixed insulin aspart (PIA) 70/30 in metformin-treated patients with type 2 diabetes mellitus (T2DM). The main findings were that exanatide was as good as PIA 70/30 for blood sugar control and was associated with less risk of side effects.
Some background
Patients with T2DM do not produce enough insulin or have insulin resistance (the body cannot effectively use glucose as energy). Therefore, the glucose builds up in the bloodstream. The first treatment options for patients with T2DM are diet with lifestyle changes and oral anti-diabetic drugs (OAD), usually metformin. However, many T2DM patients do not achieve good blood sugar control after these therapies and need insulin injections in order to lower their glucose levels. On the other hand, the use of insulin is associated with significant side effects such as weight gain and hypoglycemia. Hypoglycemia means an abnormally low blood sugar level and is an important problem because an inadequate glucose supply to the brain can lead to permanent brain damage.
Exanatide (Byetta) is approved by the U.S FDA as treatment for patients with T2DM. Like insulin, it is administered through subcutaneous (under the skin) injections and works by stimulating the pancreas to produce insulin when blood sugar levels are high. PIA 70/30 combines two kinds of insulin: 70% intermediate-acting insulin (which helps control blood sugar all through the day) and 30% rapid-acting insulin (controls blood sugar levels at mealtimes).
Methods & findings
This study included 363 T2DM patients who were being treated with metformin. Patients were randomly assigned to receive, in addition to metformin, either exanatide twice daily (181 patients) or PIA 70/30 (173 patients) twice daily. Patients were monitored for hypoglycemia and body weight changes. Blood sugar control was assessed through the value of the glycated hemoglobin or HbA1c (a test that provides an average of blood sugar levels for the last 2 to 3 months).
After 26 weeks of treatment, exanatide was shown to provide similar blood sugar control as PIA 70/30. Also, patients treated with exenatide had a lower risk for hypoglycemia compared to those who received PIA 70/30 (8% versus 20.5%). During treatment, patients in the exenatide group had lost approximately 4.1kg compared to patients in the PIA 70/30 group, who gained 1kg.
The bottom line
In summary, T2DM patients treated with metformin had the same benefits from exenatide as they did from PIA 70/30 in terms of blood sugar control. Moreover, patients treated with exanatide had less side effects such as hypoglycemia and weight gain compared to patients treated with PIA 70/30.
The fine print
This study had a short follow up period. Also, this study only included patients treated with metformin. Further studies with longer follow up periods, on larger groups of patients treated with other OAD are needed to confirm this drug’s benefits in patients with T2DM.
What’s next?
Ask your doctor if exenatide is a good treatment option for your situation.
Published By :
Diabetes Care
Date :
Feb 01, 2011
