FDA approved: Empagliflozin and linagliptin work better as a team for type 2 diabetics

This study examined whether empagliflozin (Jardiance) plus linagliptin (Tradjenta), along with metformin, was more effective than either treatment alone in patients with uncontrolled type 2 diabetes.

Patients with type 2 diabetes either do not make enough of, or are resistant to, insulin. Insulin is the hormone needed for breaking down the glucose (sugar) taken in from food. If the glucose is not broken down and used by the body, it can build up in the blood, eventually leading to nerve, blood vessel, and kidney damage. While type 2 diabetes may initially be treated with changes to diet and exercise, it is a progressive disease, and patients will eventually need glucose-lowering medications. Metformin (Glucophage) is generally the first treatment used, as it increases the body’s sensitivity to insulin. However, if metformin does not control blood glucose levels, other treatments must be used too.

The new drug empagliflozin lowers blood glucose by increasing the amount of glucose removed from the body through urine. While linagliptin lowers blood glucose levels by increasing the release of insulin from cells. Because these two medications decrease blood glucose levels in different ways, they may be especially helpful when used together in patients with type 2 diabetes not controlled with metformin alone. 

This study randomly divided 674 patients into five groups. All patients continued to receive metformin plus one of the following treatment regimens for 52 weeks.

• Group 1: empagliflozin (10 mg) and linagliptin (5 mg)
• Group 2: empagliflozin (25 mg) and linagliptin (5 mg)
• Group 3: empagliflozin (25 mg)
• Group 4: empagliflozin (10 mg)
• Group 5: linagliptin (5 mg)

HbA1c (average blood glucose levels over three months) levels were measure at the beginning of the study and after 24 and 52 weeks.

The combination of empagliflozin plus linagliptin reduced HbA1c (1.08%–1.19%) levels significantly more than either treatment alone (0.62%–0.70%).  Of the patients who had HbA1c levels higher than 7% at the start of the study, 57.8%–61.8% of patients treated with both medications had HbA1c levels less than 7% at week 24, compared to 28%–36.1% who received only one of the drugs. Patients receiving both medications still had significantly reduced HbA1c levels after 52 weeks of treatment.

Adverse (negative) events were similar across all the groups, and no patients required assistance with hypoglycemia (dangerously low blood glucose levels).

This study concluded that adding empagliflozin plus linagliptin to metformin therapy significantly reduced HbA1c levels, compared to either treatment alone, in patients with uncontrolled type 2 diabetes.