Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2017

POSTER DISCUSSION: Safety and efficacy of ertugliflozin after 52 weeks in patients with T2DM inadequately controlled on metformin and sitagliptin: VERTIS SITA2 trial extension (#331)

J. Liu 1 , R. Eldor 1 , S. Dagogo-Jack 2 , G. Amorin 3 , J. Johnson 1 , Y. Liao 4 , S. Huyck 1 , G. Golm 1 , S.G. Terra 5 , J.P. Mancuso 6 , S.S. Engel 1 , B. Lauring 1 , J. Conceicao (to present on behalf of the authors) 7
  1. Merck & Co., Inc., Kenilworth, NJ, USA
  2. University of Tennessee Health Science Centre, Memphis, TN, USA
  3. MSD, Buenos Aires, Argentina
  4. MSD R&D (China) Co., Ltd, Beijing, China
  5. Pfizer, Inc., Andover, MA, USA
  6. Pfizer, Inc., Groton, CT, USA
  7. MSD International , Singapore

Background and aims: Ertugliflozin (ERTU) is an oral sodium/glucose cotransporter 2 (SGLT2) inhibitor in development for treatment of type 2 diabetes mellitus (T2DM). This study assessed the safety and efficacy of adding ERTU 5 mg or 15 mg compared with placebo (PBO) to the dual combination of metformin and sitagliptin over 52 weeks of treatment.

Materials and Methods: Patients (n=464) with HbA1c 7.0-10.5% on stable metformin ≥1500 mg/day and sitagliptin 100 mg/day were randomised to ERTU 5 mg, ERTU 15 mg, or PBO in a double-blind Phase 3 trial. The primary outcome was at Week 26 and treatment was continued until Week 52 in a double-blind extension phase.

Results: Baseline characteristics were generally comparable between groups (mean age 59.1 years, mean HbA1c 8.0%, mean body weight 86.9 kg, mean eGFR 87.9 mL/min/1.73m2). After 52 weeks, greater reductions in HbA1c, fasting plasma glucose (FPG), body weight and systolic BP and a greater proportion of patients with an HbA1c <7.0% were observed in the ERTU groups versus PBO (Table), consistent with previously reported Week 26 findings. Rates of genital mycotic infections were higher in patients receiving ERTU compared with PBO at Week 52 (males: 4.9% [ERTU 5 mg], 3.7% [ERTU 15mg], 0 [PBO]; females: 12.0% [ERTU 5 mg], 14.1% [ERTU 15 mg], 1.9% [PBO]; all p<0.05 vs PBO except ERTU 15 mg males). The incidences of urinary tract infections, symptomatic hypoglycaemia ad hypovolaemia adverse events were not meaningfully different across groups.

Conclusion: Addition of ERTU 5 mg or 15 mg to metformin and sitagliptin provided clinically meaningful glycaemic control over 52 weeks and was well tolerated.

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