GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONISTS AND OBSTRUCTIVE SLEEP APNEA RISK USING MEDICARE DATA 2007 - 2019

Study identification

• EU PAS number:
  EUPAS1000000965
• Study ID:
  1000000965
• Official title and acronym:
  GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONISTS AND OBSTRUCTIVE SLEEP APNEA RISK USING MEDICARE DATA 2007 - 2019
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  We will implement an active-comparator, new user (ACNU) retrospective cohort study design to identify new users of GLP-1RA and new users of SGLT-2 inhibitors after a washout period of 12 months without any dispensed prescriptions for the two drug classes compared. This emulates a head-to-head trial comparing patients assigned to treatment with GLP-1RA versus SGLT-2 inhibitors. By enrolling only new users and following subjects from the start of treatment, time-varying hazards, including lag times, can be assessed, and described, while preserving the temporality of covariate assessment. The rationale behind choosing an active comparator (a guideline treatment alternative for GLP-1 agonists) is to minimize the impact of confounding by indication and other unmeasured patient characteristics (such as healthy initiator bias or frailty).; ; Aim 1: To estimate the comparative effect of GLP-1RA versus sodium-glucose co-transporter-2 (SGLT-2) inhibitors on the incidence of OSA in older adults with type 2 diabetes. ; ; Aim 2: To investigate whether comorbid OSA at baseline modifies the comparative effect of GLP-1RA (vs. SGLT-2 inhibitors) on the incidence of adapted major adverse cardiovascular events (MACE) defined as stroke, myocardial infarction, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, or all-cause mortality in older adults with type 2 diabetes.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Study timelines

Date when funding contract was signed

Planned:25/02/2026

Actual:25/03/2026

Study start date

Planned:25/03/2026

Actual:25/03/2026

Data analysis start date

Planned:25/03/2026

Actual:25/03/2026

Date of final study report

Planned:24/09/2027

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable