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

Phase 4

• Conditions: Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications
• Interventions: Drug: DPP-4 inhibiotors; Drug: SGLT2 inhibitors; Drug: Glimepiride

• Registration Number: NCT02528019
• Lead Sponsor: Kurume University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-18
• Last Update Submitted: 2015-08-18
• Study First Posted: 2015-08-19
• Last Update Posted: 2015-08-19
• Primary Completion: 2017-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPP-4 inhibitors	DPP-4 inhibiotors	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)
SGLT2 inhibitors	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)
Glimepiride	Glimepiride	glimepiride (0.5-8mg daily)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Kurume University Hospital; 🇯🇵 Kurume city, Japan