NCT06913881Completed
Comparative Cardiovascular Effectiveness of GLP-1 RAs vs. Insulin in Early-Onset Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 6 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 92100 (actual)
- First submitted
- 30 Mar 2025
- Start date
- 1 Jan 2010
- Primary completion date
- 31 Dec 2021
- Lead sponsor
- Karolinska Institutet
- Diseases
- Type 2 diabetes
- NCT number
- NCT06913881
What you commit to
- Study type: Observational
- Participants enrolled: 92100
- From 1 Jan 2010 to the primary completion date, 31 Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Individuals will be excluded if they meet one of the following criteria any time (unless stated otherwise) before or at treatment initiation: (1) other types of diabetes diagnosis recorded in NDR or NPR; (2) diagnosis of acute pancreatitis one month prior to treatment initiation; (3) diagnosis of other pancreatic diseases (chronic pancreatitis, cyst of pancreatis, etc; ICD-10 code K86) recorded in NPR; (4) use of GLP-1 RA or insulin within 1 year prior to treatment initiation, (5) advanced kidney disease (eGFR\<30 mL/min/1.73 m2, dialysis or kidney transplant \[procedure codes: KAS\[10\]\]); (6) end-stage liver disease (K70.4, K71.1, K72, Z94.4, procedure codes JJC); (7) cancer of the digestive system (ICD codes: C15-C26) or endocrine glands such as thyroid (ICD codes: C73-C75); (8) inflammatory bowel diseases (ICD-10 K50-K52)
Who the study is looking for
- We will include people diagnosed with T2D for more than 6 months and with metformin use within 6 months before the initiation of the treatment of interest (GLP-1 RA or insulin).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet, Institute of Environmental Medicine Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.