Overview

Approaches To Therapy Escalation In T2D

Status:
Withdrawn
Trial end date:
2019-09-18
Target enrollment:
Participant gender:
Summary
Type 2 diabetes mellitus (T2D) is a serious public health challenge which affects more than 9% of Canadians older than 20 years, an estimated prevalence that is anticipated to increase by over 40% in the next decade. The microvascular and macrovascular complications of T2D markedly increase the risks of hospitalization, heart disease, amputation, blindness, end stage renal disease and death, with profound socio-economic consequences for patients, families and society. Optimal glycemic control is fundamental to the management of T2D, as glycated hemoglobin (A1C) levels > 7.0% are associated with a significantly increased risk of both microvascular and cardiovascular complications. But despite detailed clinical practice guidelines for management of hyperglycemia, glycemic control remains sub-optimal in a large proportion of patients. For example, in over 5000 Canadian diabetic patients managed by primary care physicians (PCPs), more than 50% had an A1C > 7% and more than 20% an A1C > 8%. For patients not achieving glycemic target on metformin monotherapy and without clinical CVD, Diabetes Canada 2018 Guidelines suggest that the preferred oral antihyperglycemic agents as add-on therapy be either DPP-4 inhibitors or SGLT2 inhibitors if avoidance of hypoglycemia and/or weight gain is a priority. Since most patients with type 2 diabetes would benefit from avoidance of hypoglycemia and/or weight gain, there is clinical rationale for adding DPP-4 inhibitors or SGLT2 inhibitors as oral therapy before considering other oral agents like sulfonylureas or thiazolidinediones. This study is designed to explore the possibility of improving care by providing more precise management guidance to primary care physicians when utilizing DPP-4 inhibitors or SGLT2 inhibitors as add-on therapy to metformin.
Phase:
Phase 4
Details
Lead Sponsor:
LMC Diabetes & Endocrinology Ltd.
Collaborators:
Merck Sharp & Dohme Corp.
Syreon Corporation
Treatments:
Dipeptidyl-Peptidase IV Inhibitors
Ertugliflozin
Metformin
Sitagliptin Phosphate
Sodium-Glucose Transporter 2 Inhibitors