BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes
NCT ID: NCT05161429
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
550000 participants
OBSERVATIONAL
2021-07-01
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
NCT05220917
Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk
NCT05214573
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
NCT06579105
The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
NCT03239119
Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
NCT03259789
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Investigators will use a large database of electronic patient data to compare diabetes medications to determine which ones offer the best balance of risks and benefits. This database will draw from several large healthcare institutions and health insurance companies that collectively pull from a patient population of over 130 million across all major regions of the United States. Investigators will study adults aged 30 or older who have type 2 diabetes and are at moderate risk of heart attacks and strokes, and who are starting a second diabetes medication (after metformin). Investigators will use clinical trial emulation, a cutting-edge statistical technique, to compare the following classes of diabetes medications: (1) DPP4 inhibitors (alogliptin, linagliptin, sitagliptin, or saxagliptin); (2) GLP1 receptor agonists (dulaglutide, exenatide, liraglutide, or semaglutide); (3) basal insulin (degludec, detemir, glargine, or NPH); (4) SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin); and (5) sulfonylureas (glimepiride, glipizide, or glyburide).
To determine which diabetes medications provide the greatest benefit to patients, investigators will compare how much they reduce the risks of the following \\conditions: (1) heart attack; (2) heart failure; (3) stroke; (4) kidney disease; (5) eye disease; and (6) liver disease. To allow patients with diabetes and their doctors to make fully informed decisions about which diabetes medication to take, investigators will also compare these medications' risks of the following possible side effects: (1) low blood sugar; (2) kidney infection; (3) severe skin infections in the genital area; (4) foot/leg amputations; (5) broken bones; (6) pancreatitis (i.e., severe inflammation of the pancreas); (7) pancreatic cancer; (8) thyroid cancer; and (9) death from causes other than heart attacks or strokes.
In order to minimize the risk of bias and confounding, the analysis will be conducted using causal inference techniques, by emulating a randomized clinical trial (including both intention-to-treat and per-protocol analyses), while incorporating rigorous data quality checks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DPP4
Patients receiving second line diabetes treatment with dipeptidyl peptidase-4 inhibitors (DPP4) following metformin
DPP4
Dipeptidyl peptidase-4 inhibitors (DPP4) including alogliptin, linagliptin, sitagliptin, and saxagliptin
GLP1-RA
Patients receiving second line diabetes treatment with glucagon-like peptide-1 receptor agonists (GLP1-RA) following metformin
GLP-1 receptor agonist
Glucagon-like peptide-1 receptor agonists (GLP1-RA) including dulaglutide, exenatide, liraglutide and semaglutide
Basal insulin
Patients receiving second line diabetes treatment with basal insulin following metformin
Basal Insulin
degludec, detemir, glargine and NPH
SLGT2
Patients receiving second line diabetes treatment with sodium-glucose cotransporter-2 inhibitors (SLGT2) following metformin
SLGT2
Sodium-glucose cotransporter-2 inhibitors (SLGT2) including canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin
SU
Patients receiving second line diabetes treatment with sulfonylureas (SU) following metformin
SU
Sulfonylurea (SU) including glimepiride, glipizide, and glyburide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Patient-Centered Outcomes Research Institute
OTHER
Baylor College of Medicine
OTHER
Baylor Scott and White Research Institute
UNKNOWN
The Cleveland Clinic
OTHER
HealthCore, Inc.
INDUSTRY
Humana Inc.
INDUSTRY
Massachusetts General Hospital
OTHER
Medical Outcomes Management
UNKNOWN
University of Iowa
OTHER
Allina Health
UNKNOWN
Intermountain Health Care, Inc.
OTHER
Marshfield Clinic
UNKNOWN
Medical College of Wisconsin
OTHER
University of Missouri-Columbia
OTHER
University of Utah
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alexander Turchin
Associate Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexander Turchin, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HealthCore, Inc.
Wilmington, Delaware, United States
Humana
Lexington, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Greater Plains Collaborative
Beachwood, Ohio, United States
Baylor Scott & White
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Vincent Willey, PharmD
Role: primary
Vinit Nair, MS, RPh
Role: primary
Alexander Turchin, MD, MS
Role: primary
Ryan Carnahan, PhD
Role: primary
Heather Kitzman Carmichael, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998 May 12;97(18):1837-47. doi: 10.1161/01.cir.97.18.1837.
D'Agostino RB, Wolf PA, Belanger AJ, Kannel WB. Stroke risk profile: adjustment for antihypertensive medication. The Framingham Study. Stroke. 1994 Jan;25(1):40-3. doi: 10.1161/01.str.25.1.40.
Kannel WB, D'Agostino RB, Silbershatz H, Belanger AJ, Wilson PW, Levy D. Profile for estimating risk of heart failure. Arch Intern Med. 1999 Jun 14;159(11):1197-204. doi: 10.1001/archinte.159.11.1197.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021P001171
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.