Clinical trial

Comparison of Type 2 Diabetes Pharmacotherapy Regimens Using Targeted Learning

Name

739857

Description

This study is designed to help patients with type 2 diabetes and their clinicians: (a) identify which glucose lowering medications have the most favorable effects on heart health and other patient-important outcomes, (b) inform the timing of medication initiation, and (c) identify whether medication benefits apply equally to all adults with type 2 diabetes, or may be different based on age, sex, race/ethnicity, baseline heart health status, baseline renal function, or other factors.

Trial arms

Trial start

2021-07-01

Estimated PCD

2024-06-30

Trial end

2025-08-30

Status

Recruiting

Treatment

Exposure to the class of drugs known as Sulfonylureas (SU)

DPP4

Exposure to the class of drugs known as Dipeptidyl peptidase-4 inhibitors (DPP4)

SGLT2i

Exposure to the class of drugs known as Sodium-glucose cotransporter-2 inhibitors (SGLT2i)

GLP-1RA

Exposure to the class of drugs known as Glucagon-like peptide-1 receptor agonists (GLP-1RA)

SGLT2i or GLP-1RA

Exposure to either SGLT2i or GLP-1RA

Linagliptin (DPP4)

Exposure to agent Linagliptin (DPP4)

Exenatide (GLP-1RA)

Exposure to agent Exenatide (GLP1-RA)

Liraglutide (GLP-1RA)

Exposure to agent Liraglutide (GLP-1RA)

Empagliflozin (SGLT2i)

Exposure to agent Empagliflozin (SGLT2i)

Glimepiride (SU)

Exposure to agent Glimepiride (SU)

Glipizide (SU)

Exposure to Glimepiride (SU)

Glimepiride (SU) or Glipizide (SU)

Exposure to agent Glimepiride (SU) or Glipizide (SU)

SU or DPP4 (excluding saxagliptin and alogliptin)

Exposure to either SU or DPP4 excluding Saxagliptin and Alogliptin

Exenatide (GLP-1RA) or Liraglutide (GLP-1RA)

Exposure to either Exenatide (GLP-1RA) or Liraglutide (GLP-1RA)

Size

270000

Primary endpoint

Incidence of 3-point Major Adverse Cardiovascular Events (MACE)

1/1/2014 to 6/30/2021

Eligibility criteria

* Dispensing of either of the set of drugs being compared * No prior dispensing of any of the drugs compared * Evidence of Type 2 Diabetes Mellitus diagnosis * Age 18-85 * Not currently pregnant * No evidence of dementia or short-term life expectancy from prior cancer diagnoses * History of ≥2 years of continuous health plan membership * ≥1 A1c test in the past 18 months

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 270000, 'type': 'ESTIMATED'}}

Updated at

2023-11-24

1 organization

12 products

1 drug

2 indications

Organization

Kaiser Permanente

Product

Indication

Type 2 Diabetes Mellitus

Indication