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

Kurume University

Status and phase: Unknown; Phase 4

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

Treatments: Drug: SGLT2 inhibitors; Drug: DPP-4 inhibiotors; Drug: Glimepiride

Study type: Interventional

Funder types: Other

Identifiers

NCT02528019

Anti-athero

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

DPP-4 inhibitors

Active Comparator group

Description:

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)

Treatment:

Drug: DPP-4 inhibiotors

SGLT2 inhibitors

Active Comparator group

Description:

ipragliflozin (50-100mg daily), dapagliflozin (5-10mg daily), luseogliflozin (2.5-5mg), tofogliflozin (20mg daily), canagliflozin (100mg daily) or empagliflozin (10-25mg daily)

Treatment:

Drug: SGLT2 inhibitors

Glimepiride

Active Comparator group

Description:

glimepiride (0.5-8mg daily)

Treatment:

Drug: Glimepiride