NCT03813316

Approaches To Therapy Escalation In T2D

Approaches To Therapy Escalation In T2D: A Cluster Randomized Control Trial (ATTACC)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: LMC Diabetes & Endocrinology Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This cluster-based study will be conducted in a Primary Care clinical practice setting in Canada. A total of approximately 60 physician practices will be stratified into single (1 PCP) or group (\>1 PCP) practices and randomized 1:1 into two arms each consisting of approximately 30 Primary Care practices forming the Interventional arm and the Control arm. The study population will include approximately 600 male and female adult participants living in Canada; who have been diagnosed with T2D; who are being treated for this condition by their PCP; who do not have clinical cardiovascular disease (CVD) and whose eGFR is ≥ 60ml/min; who are receiving metformin at a dose of ≥1500 mg/day as monotherapy for T2D; who are not at the target for glycemic control and whose most recent A1C level is between 7.1 % and 9.0 %. Participant enrollment may be adjusted to ensure balanced distribution of glycemic values at entry across this range between study arms. All physicians in both arms will receive training on the most current Diabetes Canada 2018 Guidelines for pharmacologic management of type 2 diabetes and the role of DPP-4 inhibitors or SGLT2 inhibitors as add-on therapy to metformin. Physicians in the Interventional arm will receive additional training on specific individualized management for adding DPP-4 inhibitors or SGLT2 inhibitors to metformin. The nature of the additional training will be described separately in a physician training manual. To avoid contamination, only physicians who have been randomized to the Interventional arm will be given access to the physician training manual during the operation of the study, while those physicians randomized into the Control arm will continue to follow their routine clinical practice for utilizing DPP-4 inhibitors or SGLT2 inhibitors as add-on to metformin according to the current Diabetes Canada Practice Guidelines.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	DPP-4 inhibitor	Adding sitagliptin (DPP-4i) add-on using a fixed-dose combination with metformin (Janumet® 50/1000 mg BID).
DRUG	SGLT2 inhibitor	Adding ertugliflozin (SGLT2i) add-on using a fixed-dose combination with metformin(Segluromet® 2.5/1000 mg BID)
DRUG	SGLT2 inhibitor and DPP-4 inhibitor	Adding both a DPP-4i as Fixed dose combination (Janumet) plus SGLT2i ertugliflozin (steglatro) as add-on to metformin.

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-09-18
• Completion: 2019-09-18
• First posted: 2019-01-23
• Last updated: 2019-09-27