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

August 18, 2015 updated by: Nobuhiro Tahara, Kurume University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kurume city, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
          • Sho-ichi Yamagishi, MD, PhD
          • Phone Number: +81-942-31-7562
        • Principal Investigator:
          • Nobuhiro Tahara, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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)
Drug: DPP-4 inhibiotors
ACTIVE_COMPARATOR: 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)
Drug: SGLT2 inhibitors
ACTIVE_COMPARATOR: Glimepiride
glimepiride (0.5-8mg daily)
Drug: Glimepiride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 6 months of treatment
6 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in subcutaneous and visceral fat volume
Time Frame: 6 months of treatment
6 months of treatment
Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol
Time Frame: 6 months of treatment
6 months of treatment
Change from baseline in circulating inflammatory markers
Time Frame: 6 months of treatment
6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kurume University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (ESTIMATE)

August 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anti-athero

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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