Clinical trial

BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes

Name

2021P001171

Description

An observational study of electronic patient data to compare diabetes medications and to determine which ones offer the best balance of risks and benefits.

Trial arms

Trial start

2021-07-01

Estimated PCD

2024-06-30

Trial end

2024-06-30

Status

Recruiting

Treatment

DPP4

Dipeptidyl peptidase-4 inhibitors (DPP4) including alogliptin, linagliptin, sitagliptin, and saxagliptin

Arms:

DPP4

GLP-1 receptor agonist

Glucagon-like peptide-1 receptor agonists (GLP1-RA) including dulaglutide, exenatide, liraglutide and semaglutide

Arms:

GLP1-RA

Basal Insulin

degludec, detemir, glargine and NPH

Arms:

Basal insulin

SLGT2

Sodium-glucose cotransporter-2 inhibitors (SLGT2) including canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin

Arms:

SLGT2

Sulfonylurea (SU) including glimepiride, glipizide, and glyburide

Arms:

Size

550000

Primary endpoint

4-point major adverse cardiac events (MACE)

Follow-up begins 30 days after enrollment and ends at the earliest of a) the first study outcome; b) study end or c) loss to follow-up. Maximum duration of follow-up will be 10.5 years.

3-point major adverse cardiac events (MACE)

Follow-up begins 30 days after enrollment and ends at the earliest of a) the first study outcome; b) study end or c) loss to follow-up. Maximum duration of follow-up will be 10.5 years.

Eligibility criteria

Individuals meeting the following criteria between January 1, 2015 and December 31, 2021: * Diabetes mellitus (DM) type II * HbA1c of 7-11% within the past year * Monotherapy with metformin for at least 3 months * No prior non-metformin outpatient diabetes therapy * Aged ≥30y * At "moderate" risk of ASCVD * Men aged ≥35y and women aged ≥45y with no history\* of stroke, myocardial infarction, revascularization, or heart failure hospitalization * Men aged 30-34 and women aged 30-44 with history\* of hypertension, hyperlipidemia, retinopathy, kidney disease or neuropathy * estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2 within the past 3 years * Not pregnant at time 0 * No history\* of institutionalization with a diagnosis of dementia, metastatic cancer, end stage lung disease, end stage liver disease, pancreatitis, medullary thyroid cancer or severe UTIs * Engagement with the healthcare system: enrollment for at least 12 months and attendance of at least one outpatient encounter in the prior 12 months (\*) History will be derived from at least 12 months of EHR and claims prior to time zero and will use all available EHR and claims data between January 1, 2014 and time zero

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 550000, 'type': 'ESTIMATED'}}

Updated at

2023-06-22

1 organization

5 products

2 indications

Organization

Brigham and Women's Hospital

Product

DPP4

Indication

Diabetes Mellitus

Indication