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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02528019
• Other study ID #: Anti-athero
• Status: Recruiting
• Phase: Phase 4
• First received: August 17, 2015
• Last updated: August 18, 2015
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2015
• Source: Kurume University
• Contact: Nobuhiro Tahara, MD, PhD
• Phone: +81-942-31-7580
• Email: ntahara[@]med.kurume-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• DPP-4 inhibiotors

• SGLT2 inhibitors

• Glimepiride

Locations

Country	Name	City	State
Japan	Kurume University Hospital	Kurume city

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change from baseline in subcutaneous and visceral fat volume		6 months of treatment	Yes
Secondary	Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol		6 months of treatment	Yes
Secondary	Change from baseline in circulating inflammatory markers		6 months of treatment	Yes