August 11, 2016
By Reuters Staff
NEW YORK (Reuters Health) - Metformin monotherapy is the recommended first-line drug treatment for newly diagnosed type 2 diabetes. But a new study hints that some patients may benefit from adding the SGLT2 inhibitor empagliflozin upfront.
Empagliflozin plus metformin combinations "could be a useful treatment regimen to provide rapid, clinically relevant improvements in glycemic control" in newly diagnosed patients with type 2 diabetes, particularly those with hemoglobin A1c greater than 8.5%, the study team says.
The phase 3 randomized parallel-group study was conducted at 190 centers in 21 countries, with funding from Boehringer Ingelheim and Eli Lilly and Co, which markets empagliflozin as Jardiance and the empagliflozin/metformin combination as Synjardy.
As reported online August 4 in Diabetes Care, the study compared the efficacy and safety of initial combinations of empagliflozin plus metformin with either drug alone in 1,364 drug-naive patients with type 2 diabetes (HbA1c >7.5 to <=12%). For 24 weeks, patients took one of the following regimens:
- empagliflozin 12.5 mg with metformin 500 or 1,000 mg b.i.d.
- empagliflozin 5 mg with metformin 500 or 1,000 mg b.i.d.
- empagliflozin 10 or 25 mg q.d.
- metformin 500 or 1,000 mg b.i.d.
The primary end point was change from baseline in HbA1c at week 24.
According to the researchers, initial combinations of empagliflozin and metformin given twice daily for 24 weeks led to "statistically significant and clinically meaningful" reductions in HbA1c compared with the corresponding empagliflozin once-daily and metformin twice-daily regimens.
Changes in HbA1c of roughly 2% were achieved at week 24 in the combination therapy groups, regardless of the dose of empagliflozin or metformin, they report.
"Importantly," write Dr. Samy Hadjadj of CHU de Poitiers, in Poitiers, France, and colleagues, 57% to 70% of patients with HbA1c of 7% or higher at baseline who received combination therapy had gotten their HbA1c to below 7% at week 24, and 37% to 52% reached HbA1c lower than 6.5%.
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Even in very poorly controlled patients with type 2 diabetes (mean HbA1c of 11.5% at baseline), 53% achieved HbA1c <7% at 24 weeks, "suggesting that an initial combination of empagliflozin and metformin may provide substantial benefits in this patient population," they note.
Patients on empagliflozin/metformin combinations also saw "significant and clinically meaningful" reductions in weight, as well as significant reductions in systolic and diastolic blood pressure.
"Overall, the safety profiles of the empagliflozin and metformin twice-daily combinations were consistent with the known safety profiles for empagliflozin and metformin," the researchers say.
The proportion of patients with confirmed hypoglycemic adverse events was low in all groups (0%-1.8%) and no hypoglycemic adverse events required assistance.
"These data suggest that the initial combination of empagliflozin and metformin could represent a valuable treatment option for newly diagnosed patients with type 2 diabetes, particularly those with HbA1c >8.5%, irrespective of the dose of metformin that a patient can tolerate," the researchers conclude.
Dr. Hadjadj did not respond to request for comment by press time.
All five authors have disclosed financial relationships with Boehringer Ingelheim and Eli Lilly and three are employees of Boehringer Ingelheim.
Diabetes Care 2016.
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