Diabetes mellitus is a metabolic disease that is characterized by persistent elevations in blood glucose (hyperglycemia). This persistent elevated blood glucose causes damage to blood vessels on a microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular (peripheral artery disease, cardiovascular disease) level. Diabetes is one of the most common chronic diseases in Canada. Diabetes Canada estimated there were 3.4 million people (9.3% of the population) with diabetes in 2015 and, by 2025, this number will increase to five million people (12.1%).

The objective was to perform a systematic review of the beneficial and harmful effects of ertugliflozin 5 mg and 15 mg tablets in combination with metformin, or metformin and sitagliptin, to improve glycemic control in adult patients with type 2 diabetes mellitus when these therapies, along with diet and exercise, do not provide adequate glycemic control.

This review was conducted in tandem with the evaluation of ertugliflozin 5 mg and 15 mg tablets (Steglatro), which includes additional study data and an appraisal of the manufacturer-submitted indirect treatment comparison that are not included in this report.

Contents

• Abbreviations
• Executive Summary
  • Introduction
  • Results and Interpretation
  • Conclusions
• 1. Product Information
  • 1.1. Health Canada–Approved Indications
  • 1.2. Requested Reimbursement Criteria
  • 1.3. Manufacturer’s Rationale and Place in Therapy for the Combination
• 2. Clinical Evidence
  • 2.1. Pivotal Clinical Studies
  • 2.2. Critical Appraisal of Pivotal Clinical Studies
  • 2.3. Summary of Safety
  • 2.4. Bioequivalence
• 3. Pharmacoeconomic Evaluation
  • 3.1. Manufacturer-Submitted Cost Information
  • 3.2. Cost Comparison Table
  • 3.3. Manufacturer-Submitted Information Regarding Current Patent Status
  • 3.4. Critical Appraisal of Cost Information
• 4. Discussion
  • 4.1. Interpretation of Results
• Appendix 1. Drug Plan Listing Status for Individual Components
• Appendix 2. Summary of Patient Input
• Appendix 3. Adverse Event Summary
• References

Version: Final (with redactions)