Comparison of Type 2 Diabetes Pharmacotherapy Regimens

Summary

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.

Conditions

• Type 2 Diabetes Mellitus
• Cardiovascular Diseases

Interventions

DRUG

Glimepiride (SU)

Exposure to agent Glimepiride (SU)

DRUG

Glipizide (SU)

Exposure to Glimepiride (SU)

DRUG

Glimepiride (SU) or Glipizide (SU)

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

DRUG

SU or DPP4 (excluding saxagliptin and alogliptin)

Exposure to either SU or DPP4 excluding Saxagliptin and Alogliptin

DRUG

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

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

DRUG

Linagliptin (DPP4)

Exposure to agent Linagliptin (DPP4)

DRUG

Exenatide (GLP-1RA)

Exposure to agent Exenatide (GLP1-RA)

DRUG

Liraglutide (GLP-1RA)

Exposure to agent Liraglutide (GLP-1RA)

DRUG

Empagliflozin (SGLT2i)

Exposure to agent Empagliflozin (SGLT2i)

DRUG

SU

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

DRUG

DPP4

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

DRUG

SGLT2i

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

DRUG

GLP-1RA

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

DRUG

SGLT2i or GLP-1RA

Exposure to either SGLT2i or GLP-1RA

Sponsors & Collaborators

• Geisinger Clinic

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• HealthPartners Institute

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Romain S. Neugebauer, PhD · Kaiser Permanente

• Patrick J O'Connor, MD, MA, MPH · HealthPartners Institute

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2024-12-31

Completion

2025-03-12

FDA Drug

Yes

Countries

• United States

Study Locations