Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT05161429

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

DPP4

GLP-1 receptor agonist

Basal Insulin

SLGT2

SU

Study Details

Brief summary:

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

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT05161429

Start date

Jul 1, 2021

Status verified date

Jun, 2023

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

550000 participants

Anticipated

Interventions and Outcome Measures

Arms

DPP4

Patients receiving second line diabetes treatment with dipeptidyl peptidase-4 inhibitors (DPP4) following metformin

GLP1-RA

Patients receiving second line diabetes treatment with glucagon-like peptide-1 receptor agonists (GLP1-RA) following metformin

Basal insulin

Patients receiving second line diabetes treatment with basal insulin following metformin

SLGT2

Patients receiving second line diabetes treatment with sodium-glucose cotransporter-2 inhibitors (SLGT2) following metformin

SU

Patients receiving second line diabetes treatment with sulfonylureas (SU) following metformin

Interventions

DPP4

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

GLP-1 receptor agonist

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

Basal Insulin

degludec, detemir, glargine and NPH

SLGT2

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

SU

Sulfonylurea (SU) including glimepiride, glipizide, and glyburide

Primary outcome measure

  • 4-point major adverse cardiac events (MACE) [ Time Frame: 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) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Emma Hegermiller, MS

617-732-5661emma@bestmed.org

Alexander Turchin, MD, MS

617-732-5661aturchin@bwh.harvard.edu

Locations

HealthCore, Inc.

Recruiting

Wilmington, Delaware, United States, 19801

Humana

Recruiting

Lexington, Kentucky, United States, 40512-4611

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Greater Plains Collaborative

Recruiting

Beachwood, Ohio, United States, 44122

Baylor Scott & White

Recruiting

Dallas, Texas, United States, 75246

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 22, 2023

Last verified

Jun, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-06-22.