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

NCT ID: NCT02528019

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-08-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

DPP-4 inhibiotors

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

SGLT2 inhibitors

Intervention Type DRUG

Glimepiride

glimepiride (0.5-8mg daily)

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

Interventions

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DPP-4 inhibiotors

Intervention Type DRUG

SGLT2 inhibitors

Intervention Type DRUG

Glimepiride

Intervention Type DRUG

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kurume University

OTHER

Sponsor Role lead

Responsible Party

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Nobuhiro Tahara

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nobuhiro Tahara, MD, PhD

Role: STUDY_CHAIR

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

Locations

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Kurume University Hospital

Kurume, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Nobuhiro Tahara, MD, PhD

Role: CONTACT

+81-942-31-7580

Facility Contacts

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Nobuhiro Tahara, MD, PhD

Role: primary

+81-942-31-7580

Sho-ichi Yamagishi, MD, PhD

Role: backup

+81-942-31-7562

References

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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.

Reference Type DERIVED
PMID: 29766812 (View on PubMed)

Other Identifiers

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Anti-athero

Identifier Type: -

Identifier Source: org_study_id

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