NCT02528019

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

August 17, 2015

Last Update Submit

August 18, 2015

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

DPP-4 inhibitors

ACTIVE COMPARATOR

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

SGLT2 inhibitors

ACTIVE COMPARATOR

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

Glimepiride

ACTIVE COMPARATOR

glimepiride (0.5-8mg daily)

Drug: Glimepiride

Interventions

DPP-4 inhibiotorsDRUG
DPP-4 inhibitors
SGLT2 inhibitorsDRUG
SGLT2 inhibitors
GlimepirideDRUG
Glimepiride

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetic patients
  • Must be able to swallow tablets
  • never received DPP-4 inhibitors or SGLT2 inhibitors

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kurume University Hospital

Kurume, 830-0011, Japan

RECRUITING

Related Publications (1)

  • Bekki M, Tahara N, Tahara A, Igata S, Honda A, Sugiyama Y, Nakamura T, Sun J, Kumashiro Y, Matsui T, Fukumoto Y, Yamagishi SI. Switching Dipeptidyl Peptidase-4 Inhibitors to Tofogliflozin, a Selective Inhibitor of Sodium-Glucose Cotransporter 2 Improve Arterial Stiffness Evaluated by Cardio-Ankle Vascular Index in Patients with Type 2 Diabetes: A Pilot Study. Curr Vasc Pharmacol. 2019;17(4):411-420. doi: 10.2174/1570161116666180515154555.

    PMID: 29766812DERIVED

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitorsglimepiride

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Nobuhiro Tahara, MD, PhD

    Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine

    STUDY CHAIR

Central Study Contacts

Nobuhiro Tahara, MD, PhD

CONTACT

+81-942-31-7580ntahara@med.kurume-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2018

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

JP(1)