Which should be given first, DPP-4 inhibitor or SGLT2 inhibitor, in combination therapy of these two anti-diabetic drugs?

UMIN ID: UMIN000038377

Registered date:26/10/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2019/09/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

First, linagliptin 5mg is administered for 3 months. Then, add canagliflozin 100mg and administer 2 drugs in combination for 3 months.
First, canagliflozin 100mg is administered for 3 months. Then, add linagliptin 5mg and administer 2 drugs in combination for 3 months.

Outcome(s)

• Primary Outcome: Change from baseline in HbA1c (after 6 months)
• Secondary Outcome: Hemoglobin, hematocrit, erythropoietin, AST, ALT, gamma GTP, Cre, eGFR, Na, K, Cl, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, RLP cholesterol, uric acid, BNP, cystatin C, CRP, hydroxybutyric acid, glucagon, KIM1, LFABP, 25(OD)VitD, leptin , IL-6, ApoB48, Treg, Th17, HMW adiponectin, FGF21, folic acid ,urinary glucose, urinary protein, urinary keton, urinary albumin, visceral fat area, BMI, blood-pressure, pulse, rate, DPP4 concentration and DPP4 activity. (3 months and 6 months after treatment)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)type 1 diabetes 2)patients with severe renal dysfunction (eGFR < 30 ml/min/1.73m2) 3)patients with liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 4)a pregnant woman and/or a woman under breast-feeding 5)patients who have diabetic proliferative retinopathy. 6)patients who have an anamnesis of hypersensitivity to the ingredient of a trial drugs. 7)patients who reciving GLP-1 recepter agonist. 8)patients who thought to be inappropriate to enter this study for some medical reasons by physician's judgments.

Related Information

• Primary Sponsor: Dokkyo Medical University
• Source(s) of Monetary Support: self funding