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NCT06913881
Comparative Cardiovascular Effectiveness of GLP-1 RAs vs. Insulin in Early-Onset Type 2 Diabetes
trial testing GLP-1 in Type 2 Diabetes Mellitus (T2DM) in 92,100 participants. Completed in 31 January 2025.
31 December 2021
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 92,100 |
| Start date | 1 January 2010 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 January 2025 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- GLP-1 — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus (T2DM) — all drugs for Type 2 Diabetes Mellitus (T2DM) →
Sponsor
Karolinska Institutet
Who can join
18 and older, any sex, with Type 2 Diabetes Mellitus (T2DM). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06913881
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Currently open trials in the same condition.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06913881 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 6 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06913881.
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