Status:
WITHDRAWN
Approaches To Therapy Escalation In T2D
Lead Sponsor:
LMC Diabetes & Endocrinology Ltd.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Syreon Corporation
Conditions:
Type2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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 P...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years of age or older
- Previously diagnosed with T2D
- Have a glycated hemoglobin (A1C) result at Baseline between 7.1% and 9%
- Have an eGFR value at Baseline ≥60 ml/min/1.73m2
- Receiving stable (≥ 8 weeks) metformin at a dose of ≥1500 mg/day as monotherapy for T2D
- Ability to take oral medication and be willing to adhere to the study intervention regimen
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
- No reason for investigator to suspect they will not tolerate the study medication
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Treated with antihyperglycemic agents other than metformin monotherapy.
- Known allergies or contraindications to the use of either DPP-4 inhibitors or SGLT2 inhibitors
- 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.
- Known pregnancy or current lactation
- Women of child bearing age not willing to use a method of contraception.
- Febrile illness within 30 days of signing informed consent
- Treatment with another investigational drug or other intervention within 90 days of signing informed consent
- Any physical or psychological condition(s) or diagnoses that in the opinion of the treating physician may preclude participation
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03813316
Start Date
May 1 2019
End Date
September 18 2019
Last Update
September 27 2019
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