Effects of the DPP-4 or SGLT2 Inhibitors on the Metabolic Cardiovascular Systems in Patients With Type 2 Diabetes Mellitus.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Kurume University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index
Study Overview
Brief Summary
Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of type 2 diabetic patients
- •Must be able to swallow tablets
- •never received DPP-4 inhibitors or SGLT2 inhibitors
Exclusion Criteria
- •uncontrolled diabetes (fasting plasma glucose>200 mg/dL)
- •receiving insulin therapy
- •hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal)
- •inflammatory disorders
- •neoplastic disorders
- •recent (<3months) acute coronary syndrome and stroke
- •any acute infection
Arms & Interventions
DPP-4 inhibitors
sitagliptin (25-100mg daily), vildagliptin (50-100mg daily), alogliptin (12.5-25mg daily), linagliptin (2.5-5mg daily), teneligliptin (20-40mg), anagliptin (100-200mg daily), saxagliptin (2.5-5mg daily) or trelagliptin (50-100mg weekly)
Intervention: DPP-4 inhibiotors (Drug)
SGLT2 inhibitors
ipragliflozin (50-100mg daily), dapagliflozin (5-10mg daily), luseogliflozin (2.5-5mg), tofogliflozin (20mg daily), canagliflozin (100mg daily) or empagliflozin (10-25mg daily)
Intervention: SGLT2 inhibitors (Drug)
Glimepiride
glimepiride (0.5-8mg daily)
Intervention: Glimepiride (Drug)
Outcomes
Primary Outcomes
Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index
Time Frame: 6 months of treatment
Secondary Outcomes
- Change from baseline in subcutaneous and visceral fat volume(6 months of treatment)
- Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol(6 months of treatment)
- Change from baseline in circulating inflammatory markers(6 months of treatment)
Investigators
Nobuhiro Tahara
Associate Professor
Kurume University