Dose‐ranging efficacy and safety study of ertugliflozin, a sodium‐glucose co‐transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin

Mar 11, 2015Diabetes, obesity & metabolism

Ertugliflozin dose effects on blood sugar control and safety in type 2 diabetes patients already taking metformin

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Abstract

A total of 328 patients with type 2 diabetes experienced significant reductions in HbA1c concentration with ertugliflozin doses of 1-25 mg/day.

Ertugliflozin led to placebo-corrected reductions in HbA1c of -0.45% to -0.72% at 12 weeks.
Fasting plasma glucose decreased significantly by -1.17 to -1.90 mmol/l with ertugliflozin.
Body weight reductions ranged from -1.15% to -2.15% in patients taking ertugliflozin.
Systolic blood pressure decreased by -3.4 to -4.0 mmHg with ertugliflozin doses of 5-25 mg/day.
Adverse events were reported in 2.7% of participants, with no dose-related increase in frequency for ertugliflozin.

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AIM: To investigate the efficacy and safety of ertugliflozin, in a phase II dose-ranging study, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.

METHODS: A total of 328 patients [mean T2DM duration, 6.3 years; mean glycated haemoglobin (HbA1c), 8.1%] were randomized to once-daily ertugliflozin (1, 5, 10, 25 mg), sitagliptin (100 mg) or placebo, for 12 weeks. The primary efficacy endpoint was change from baseline to week 12 in HbA1c concentration and the secondary efficacy endpoints were changes from baseline to week 12 in body weight, fasting plasma glucose (FPG) and systolic/diastolic blood pressure (SBP/DBP). Safety and tolerability were also monitored.

RESULTS: Ertugliflozin (1-25 mg/day) produced significant reductions in HbA1c concentration [placebo-corrected least-squares mean (LSM) -0.45% (1 mg) to -0.72% (25 mg); p ≤ 0.002, similar to sitagliptin (-0.76%; p = 0.0001)], FPG (LSM -1.17 to -1.90 mmol/l; p < 0.0001) and body weight (-1.15 to -2.15%; p < 0.0001). The LSM SBP decreased by -3.4 to -4.0 mmHg from baseline with ertugliflozin 5-25 mg/day. No reductions in body weight or blood pressure were observed with sitagliptin. After randomization, 2.7% of patients (9/328) withdrew because of adverse events (AEs); the frequency of AEs was evenly distributed across groups. No dose-related increase in AE frequency occurred with ertugliflozin. Hypoglycaemia was reported in 5 (1.5%) randomized participants (all in the ertugliflozin group). The frequency of urinary tract infection was 3.2% for ertugliflozin (pooled across groups), 1.8% for sitagliptin, 7.4% for placebo, and the frequency of genital fungal infections was 3.7% for ertugliflozin (pooled) versus 1.9% for placebo.

CONCLUSION: Ertugliflozin (1-25 mg/day) improved glycaemic control, body weight and blood pressure in patients with T2DM suboptimally controlled on metformin, and was well tolerated.

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Dose‐ranging efficacy and safety study of ertugliflozin, a sodium‐glucose co‐transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin

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