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Late-Stage Data Support Efficacy of Saxagliptin/Dapagliflozin in Patients With Type 2 Diabetes

Combo treatment reduces hemoglobin compared with individual components

Positive results have been reported from a phase III study evaluating the investigational combination of saxagliptin/dapagliflozin (AstraZeneca) as a dual add-on therapy in adult patients with type 2 diabetes who were inadequately controlled with metformin.

Results from the combination study found that patients treated with saxagliptin/dapagliflozin plus metformin achieved significantly greater reductions in hemoglobin A1c (HbA1c) compared with either agent alone plus metformin at 24 weeks, with an adjusted mean change from baseline HbA1c of –1.47% in the saxagliptin/dapagliflozin combination group compared with –0.88% in the saxagliptin group and –1.20% in the dapagliflozin group. More patients in the saxagliptin/dapagliflozin group (41%) achieved goal HbA1c levels of less than 7% compared with patients in the saxagliptin (18%) and dapagliflozin (22%) groups.

Patients treated with saxagliptin/dapagliflozin achieved a significantly greater adjusted mean reduction from baseline in 2-hour postprandial glucose (PPG) compared with the saxagliptin group but not the dapagliflozin group. The adjusted mean reduction in fasting plasma glucose (FPG) was greater in the saxagliptin/dapagliflozin combination group (–38 mg/dL) than in the saxagliptin group (–14 mg/dL) but was similar to that in the dapagliflozin group (–32 mg/dL).

Overall rates of adverse events, including hypoglycemia, were similar among the three treatment groups, and most were reported as mild or moderate in severity.

This 24-week, phase III, randomized, double-blind, active-controlled, parallel-group trial was designed to evaluate the efficacy and safety of the combination of saxagliptin/dapagliflozin as dual add-on therapy in adult patients with type 2 diabetes with inadequate glycemic control with metformin. The study’s primary endpoint was the mean change in HbA1c from baseline to week 24. Secondary endpoints included the mean change from baseline in 2-hour PPG during a liquid meal test, FPG, and body weight at week 24 in the saxagliptin/dapagliflozin combination group compared with the saxagliptin group, as well as the proportion of patients who achieved glycemic response (defined as HbA1c < 7%).

The study included 534 adult patients (aged 18 years or older) with type 2 diabetes with inadequate glycemic control (HbA1c ≥ 8% and ≤ 12%) who were receiving extended-release metformin (≥ 1,500 mg/day). The patients were randomly assigned to receive the combination of saxagliptin 5 mg and dapagliflozin 10 mg added to metformin; saxagliptin and metformin added to placebo; or dapagliflozin and metformin added to placebo for 24 weeks.

Saxagliptin (Onglyza, Bristol-Myers Squibb/AstraZeneca) belongs to the class of medications called dipeptidyl peptidase 4 (DPP-4) inhibitors, which work by increasing the activity of the incretin hormones, thereby increasing the release of insulin when glucose levels are elevated and reducing the levels of sugar (glucagon) produced by the liver. Dapagliflozin (Farxiga, Bristol-Myers Squibb/AstraZeneca) is part of a newer class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which remove glucose via the kidneys.

Diabetes is estimated to affect 25.8 million people in the U.S. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in adults.

Source: AstraZeneca; May 13, 2014.

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