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Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an
Naoto Katakami1,2, Tomoya Mita3, Hidenori Yoshii4
1Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.
Introduction:
Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker.
Methods:
The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function.
Conclusion:
This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD.
Funding:
Kowa Co., Ltd.
Clinical Trial Registration:
UMIN000017607.
Insights
This study investigates tofogliflozin
Area of Science:
- Cardiology and Endocrinology
- Pharmacology of anti-diabetic agents
Background:
- Sodium-glucose co-transporter-2 (SGLT2) inhibitors improve glycemic control and cardiovascular risk factors in type 2 diabetes (T2DM).
- Atherosclerosis progression is a major concern in T2DM patients.
- Carotid intima-media thickness (IMT) is an established marker for cardiovascular disease (CVD).
Purpose of the Study:
- To evaluate the preventive effects of tofogliflozin, an SGLT2 inhibitor, on atherosclerosis progression in T2DM patients.
- To assess changes in carotid intima-media thickness (IMT) as a primary outcome.
Main Methods:
- The UTOPIA trial is a prospective, randomized, open-label, blinded-endpoint, multicenter study.
- 340 T2DM subjects without prior CVD were randomized to tofogliflozin or conventional treatment.
- Primary outcomes measured changes in mean and maximum carotid IMT over 104 weeks via carotid echography.
Main Results:
- Results are pending and expected shortly.
- The study will provide data on tofogliflozin's impact on atherosclerosis markers.
Conclusions:
- This is the first study to examine SGLT2 inhibitors' effect on carotid IMT progression in T2DM patients without CVD history.
- Findings are anticipated to offer valuable clinical insights for preventing diabetic atherosclerosis and subsequent CVD.
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