| Trial ID: | L2740 |
| Source ID: | NCT05161429
|
| Associated Drug: |
Dpp4
|
| Title: |
BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes
|
| Acronym: |
BESTMED
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: DPP4|DRUG: GLP-1 receptor agonist|DRUG: Basal Insulin|DRUG: SLGT2|DRUG: SU
|
| Outcome Measures: |
Primary: 4-point major adverse cardiac events (MACE), Includes: a) death from cardiovascular causes b) non-fatal myocardial infarction (MI) c) non-fatal stroke and d) hospitalization for heart failure (HF), 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), Includes: a) death from cardiovascular causes as reported in the National Death Index b) non-fatal MI and c) non-fatal stroke, 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. | Secondary: Adverse outcomes, Includes a) severe hypoglycemia b) severe urinary tract infection (UTI) c) Fournier's gangrene d) lower extremity amputation e) bone fracture f) diabetic ketoacidosis (DKA) g) pancreatitis h) pancreatic cancer i) medullary thyroid cancer j) non-cardiovascular death, 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.|Severe clinical outcomes, Includes: a) hospitalization for \>= 30 days with any of the primary or secondary outcome endpoints as the primary or admitting diagnosis b) ICU admission with any of the primary or secondary outcome endpoints as the primary or admitting diagnosis or c) death from any cause, 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.|Non-cardiovascular outcomes, Includes a) nephropathy b) diabetic retinopathy requiring treatment c) non-alcoholic fatty liver disease (NAFLD) with advanced fibrosis / nonalcoholic steatohepatitis (NASH), 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.
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital | Collaborators: Patient-Centered Outcomes Research Institute|Baylor College of Medicine|Baylor Scott and White Research Institute|The Cleveland Clinic|HealthCore, Inc.|Humana Inc.|Massachusetts General Hospital|Medical Outcomes Management|University of Iowa|Allina Health|Intermountain Health Care, Inc.|Marshfield Clinic|Medical College of Wisconsin|University of Missouri-Columbia|University of Utah
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
550000
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2021-07-01
|
| Completion Date: |
2024-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-06-22
|
| Locations: |
HealthCore, Inc., Wilmington, Delaware, 19801, United States|Humana, Lexington, Kentucky, 40512-4611, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|Greater Plains Collaborative, Beachwood, Ohio, 44122, United States|Baylor Scott & White, Dallas, Texas, 75246, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05161429
|
