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Ertugliflozin safe and effective for treatment of type 2 diabetes

Ertugliflozin safe and effective for treatment of type 2 diabetes

Ertugliflozin is safe and effective in causing an improvement in long-term glycemic control among type 2 diabetes (T2D) patients whose diabetes is inadequately controlled on metformin, according to a new study published in the journal Diabetes, Obesity, and Metabolism.

Silvina Gallo, Pfizer Deutschland GmbH, Berlin, Germany, and colleagues conducted this phase III, randomized, double‐blind study to evaluate long-term efficacy and safety of ertugliflozin in adults with T2D inadequately controlled on metformin monotherapy.

The study involved a 26-week placebo-controlled period (Phase A) and a 78-week period (Phase B) during which blinded glimepiride was added to non rescued placebo participants with fasting fingerstick glucose ≥6.1 mmol/L. Overall, 621 participants were enrolled in the trial and 581 participants entered Phase B, in which they received at least one dose of the study medication.

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Key Findings:

  • The mean change in HbA1c from baseline with ertugliflozin 5 and 15 mg, respectively, was −0.7 and −1 percent at week 52 and −0.6 and −0.9 percent at week 104.
  • At week 52, 34.8 and 36.6 percent of participants had HbA1c <7 percent with doses of 5 and 15 mg, respectively, and 24.6 and 33.7 percent met this outcome at week 104.
  • ertugliflozin reduced fasting plasma glucose, body weight, and systolic blood pressure (SBP).
  • The incidence of female genital mycotic infections was higher with ertugliflozin.
  • Symptomatic hypoglycemia was lower for ertugliflozin compared with placebo/glimepiride.
  • Bone mineral density (BMD) changes were similar to those with placebo/glimepiride except for total hip, where the reduction in BMD was greater with ertugliflozin 15 mg versus placebo/glimepiride.

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“In patients with T2DM and inadequate glycemic control on metformin monotherapy, adding treatment with ertugliflozin 15 mg and 5 mg provided clinically meaningful and durable improvements in glycemic control, body weight, and SBP over 104 weeks,” the authors write. “Ertugliflozin was well tolerated, with non‐clinically relevant changes in BMD.”

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Source: With inputs from Diabetes, Obesity, and Metabolism

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