Metabolic and Cardiovascular Effects of Dipeptidyl Peptidase-4 (DPP-4) or Sodium-glucose Co-transporter Type 2 (SGLT2) Inhibitors

Study Overview
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Brief Summary
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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.

Official Title
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Effects of the DPP-4 or SGLT2 Inhibitors on the Metabolic Cardiovascular Systems in Patients With Type 2 Diabetes Mellitus.

Conditions
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Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications

Intervention / Treatment
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* Drug: DPP-4 inhibiotors
* Drug: SGLT2 inhibitors
* Drug: Glimepiride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DPP-4 inhibitors<br>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) | Drug: DPP-4 inhibiotors<br> <br> |
| Active Comparator: SGLT2 inhibitors<br>ipragliflozin (50-100mg daily), dapagliflozin (5-10mg daily), luseogliflozin (2.5-5mg), tofogliflozin (20mg daily), canagliflozin (100mg daily) or empagliflozin (10-25mg daily) | Drug: SGLT2 inhibitors<br> <br> |
| Active Comparator: Glimepiride<br>glimepiride (0.5-8mg daily) | Drug: Glimepiride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index |  | 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |