Approaches To Therapy Escalation In T2D

• Status: Withdrawn
• Trial end date: 2019-09-18
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18 years of age or older

4. Previously diagnosed with T2D

5. Have a glycated hemoglobin (A1C) result at Baseline between 7.1% and 9%

6. Have an eGFR value at Baseline ≥60 ml/min/1.73m2

7. Receiving stable (≥ 8 weeks) metformin at a dose of ≥1500 mg/day as monotherapy for T2D

8. Ability to take oral medication and be willing to adhere to the study intervention regimen

9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

10. No reason for investigator to suspect they will not tolerate the study medication

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Treated with antihyperglycemic agents other than metformin monotherapy.

2. Known allergies or contraindications to the use of either DPP-4 inhibitors or SGLT2 inhibitors

3. Presence of clinical evidence of cardiovascular disease including a history of heart failure, myocardial infarction, unstable angina, severe atherosclerotic cardiovascular disease on angiography, peripheral arterial disease and/or prior low extremity amputation, revascularization or stroke.

4. Known pregnancy or current lactation

5. Women of child bearing age not willing to use a method of contraception.

6. Febrile illness within 30 days of signing informed consent

7. Treatment with another investigational drug or other intervention within 90 days of signing informed consent

8. Any physical or psychological condition(s) or diagnoses that in the opinion of the treating physician may preclude participation