BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes

NCT05161429 | Unknown FDA Drug

• 1 other identifier: 2021P001171
• Study Type: observational
• Target: 550,000
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Adverse outcomes

  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

  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

  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.

Study Arms (5)

DPP4

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

Drug: DPP4

GLP1-RA

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

Drug: GLP-1 receptor agonist

Basal insulin

Patients receiving second line diabetes treatment with basal insulin following metformin

Drug: Basal Insulin

SLGT2

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

Drug: SLGT2

SU

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

Drug: SU

Interventions

DPP4 DRUG

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

DPP4

GLP-1 receptor agonist DRUG

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

GLP1-RA

Basal Insulin DRUG

degludec, detemir, glargine and NPH

Basal insulin

SLGT2 DRUG

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

SLGT2

SU DRUG

Sulfonylurea (SU) including glimepiride, glipizide, and glyburide

SU

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is adults aged 30 or older who have type 2 diabetes and are at moderate risk of Atherosclerotic Cardiovascular Disease (ASCVD), and who are starting a second diabetes medication (after metformin). Patients from collaborating institutions will be included in the analysis based on study population inclusion and exclusion 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Baylor College of Medicine: collaborator
• Baylor Scott and White Research Institute: collaborator
• The Cleveland Clinic: collaborator
• HealthCore, Inc.: collaborator
• Humana Inc.: collaborator
• Massachusetts General Hospital: collaborator
• Medical Outcomes Management: collaborator
• University of Iowa: collaborator
• Allina Health: collaborator
• Intermountain Health Care, Inc.: collaborator
• Marshfield Clinic: collaborator
• Medical College of Wisconsin: collaborator
• University of Missouri-Columbia: collaborator
• University of Utah: collaborator

Study Sites (5)

HealthCore, Inc.

Wilmington, Delaware, 19801, United States

RECRUITING

Humana

Lexington, Kentucky, 40512-4611, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Greater Plains Collaborative

Beachwood, Ohio, 44122, United States

RECRUITING

Baylor Scott & White

Dallas, Texas, 75246, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 9603539 BACKGROUND

• 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.

  PMID: 8266381 BACKGROUND

• 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.

  PMID: 10371227 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexander Turchin, MD, MS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Hegermiller, MS

CONTACT

617-732-5661; emma@bestmed.org

Alexander Turchin, MD, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 17, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)