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Comparative Cardiovascular Effectiveness of GLP-1 RAs vs. Insulin in Early-Onset Type 2 Diabetes

NCT06913881 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92100

Last updated 2025-04-06

No results posted yet for this study

Summary

The incidence of early-onset type 2 diabetes (T2D) is increasing globally. People with early-onset T2D have faster beta-cell deterioration and more aggressive diabetes progression than their late-onset counterparts. However, there is no specific treatment guideline tailored to the early-onset population.

Glucagon-like peptide-1 receptor agonists (GLP-1 RA) belong to a new class of glucose-lowering drugs that have been shown to promote weight loss and reduce incidence of cardiovascular diseases (CVD) in individuals with (mostly late-onset) T2D. Given the much higher prevalence of obesity, a key risk factor for CVD, in early-onset T2D, the cardiovascular benefits of the GLP-1 RA may be more pronounced in early-onset than in late-onset T2D. In addition, insulin use is highly prevalent in people with early-onset T2D. However, no randomized controlled trial (RCT) has evaluated the comparative effectiveness of GLP-1 RA and insulin on CVD incidence and CVD risk factors in this population.

Our objective is to investigate the optimal treatment strategies in people with early-onset T2D. Specifically, we aim to (1) compare CVD risk in GLP-1 RA and insulin users and (2) examine changes in key CVD risk factors, such as HbA1c, BMI, and lipid profiles, before and after initiation of GLP-1 RA, SGLT2 inhibitors, and insulin.

Based on real-world data from Sweden we will emulate a target trial to minimize selection bias and confounding.

This study will generate robust evidence to guide clinicians in optimizing treatment for early-onset T2D. Given the rising burden of this condition and the lack of specific treatment recommendations, our findings have the potential to improve long-term cardiovascular outcomes in this high-risk population.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

GLP-1

We will compare people who have picked up GLP1 to those who have picked up insulin at any Swedish pharmacy

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2021-12-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06913881 on ClinicalTrials.gov