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

Safety and efficacy of ertugliflozin plus sitagliptin vs either treatment alone after 52 wks in patients with T2DM poorly controlled on metformin: VERTIS FACTORIAL extension (#108)

Richard Pratley 1 , Annaswamy Raji 2 , Roy Eldor 2 , Sheila Sunga 2 , Yanping Qiu 3 , Jeremy Johnson 2 , Susan Huyck 2 , Gregory Golm 2 , Steven Terra 4 , James Mancuso 5 , Samuel Engel 2 , Brett Lauring 2 , Joao Conceicao (to present on behalf of the authors) 6
  1. Florida Hospital Translational Research Institute, Orlando, FL, USA
  2. Merck & Co., Inc., Kenilworth, NJ, USA
  3. MSD R&D (China) Co., Ltd, Beijing, China
  4. Pfizer, Inc., Andover, MA, USA
  5. Pfizer, Inc., Groton, CT, USA
  6. 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 compared the safety and efficacy of co-administration of ERTU 5 mg or 15 mg plus sitagliptin (SITA) 100 mg compared with either treatment alone over 52 weeks.

Methods: In a double-blind Phase 3 trial, 1233 patients with HbA1c 7.5–11.0% on stable metformin monotherapy ≥1500 mg/day were randomised into 5 groups (Table). ERTU + SITA combinations were compared with corresponding ERTU doses (5 or 15 mg) or SITA alone. The primary outcome was at Week 26; treatment was continued in a double-blind 26‑week extension phase.

Results: Mean HbA1c at baseline was 8.6%. After 52 weeks in the ERTU+SITA groups, greater reductions in HbA1c, fasting plasma glucose (FPG) (vs ERTU or SITA alone), body weight and systolic BP (vs SITA alone) were observed (Table). The odds of having an HbA1c <7.0% were greater for ERTU+SITA versus ERTU or SITA alone. Administration of ERTU alone or with SITA was well tolerated overall. Rates of genital mycotic infections with ERTU+SITA were similar to those observed with ERTU alone, and significantly higher than those observed with SITA alone (p<0.05, except ERTU 5 mg+SITA in females). Symptomatic hypoglycaemia rates were not significantly different among groups but were highest in the ERTU 15 mg+SITA group. Overall the incidences of urinary tract infection and hypovolaemia were similar across groups.

Conclusion: Co-administration of ERTU+SITA resulted in effective glycaemic control sustained over 52 weeks and was generally well-tolerated.

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