Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlle
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ORIGINAL RESEARCH
Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials Shrita Patel . Anne Hickman . Robert Frederich . Susan Johnson . Susan Huyck . James P. Mancuso . Ira Gantz . Steven G. Terra
Received: December 20, 2019 Ó The Author(s) 2020
ABSTRACT Introduction: The sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin is approved for the treatment of adults with type 2 diabetes mellitus (T2DM). This analysis was conducted on safety data pooled from phase 3 studies using ertugliflozin 5 mg or 15 mg versus placebo or an active comparator. Methods: The placebo pool (n = 1544) comprised data from three similarly designed 26-week placebo-controlled studies. The broad pool (n = 4849) comprised these three placebocontrolled studies plus four placebo- or active-
Enhanced Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare. 11982252. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s13300020-00803-3) contains supplementary material, which is available to authorized users. S. Patel (&) S. Huyck I. Gantz Merck & Co., Inc., Kenilworth, NJ, USA e-mail: [email protected] A. Hickman J. P. Mancuso Pfizer Inc., Groton, CT, USA R. Frederich S. Johnson Pfizer Inc., Collegeville, PA, USA S. G. Terra Pfizer Inc., Andover, MA, USA
controlled studies with treatment durations of up to 104 weeks. Results: In the placebo pool, there were no notable differences across groups in the incidence of adverse events (AEs), serious AEs, or AEs resulting in discontinuation from study medication, while associations were observed with genital mycotic infection in both females (3.0%, 9.1%, and 12.2% in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively) and males (0.4%, 3.7%, 4.2%), thirst (0.2%, 1.3%, 1.0%), and increased urination (1.0%, 2.7%, 2.4%). In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate \ 60 ml/min/1.73 m2, aged C 65 years, or who were taking diuretics. Ertugliflozin was not associated with increased urinary tract infection, fracture, hypoglycemia, pancreatitis, renal or hepatic injury, hypersensitivity, malignancy, or venous thromboembolism. Small numbers of patients were reported with lower limb amputation [0.1% (non-ertugliflozin group), 0.2% (ertugliflozin 5 mg), 0.5% (ertugliflozin 15 mg)]. There were three cases of ketoacidosis (all ertugliflozin 15 mg) and no cases of Fournier’s gangrene. Conclusion: This pooled analysis showed that ertugliflozin was generally well tolerated in a large population of patients with T2DM with and without moderate renal impairment who were taking a range of background diabetes medications including insulin and insulin
Diabetes Ther
secretagogs, with results that are generally consistent with those for other SGLT2 inhibitors. Trial Registration: Clinicaltrials.gov indentifier, NCT02033889, NCT01958671,
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