NIPH Clinical Trials Search

Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	type 2 diabetes mellitus
Date of first enrollment	2014/09/07
Target sample size	36
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Sitagliptin Vildagliptin Teneligliptin Linagliptin Alogliptin Saxagliptin Dapagliflozin

Outcome(s)

Primary Outcome	Mean Amplitude of glycemic excursions: MAGE
Secondary Outcome	1) M-value 2) glucose area under the curve (over 180mg/dl and below 70mg/dl) 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure 8)multiple regression analysis 9)insulin dose

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	80years-old
Gender	Male and Female
Include criteria
Exclude criteria	1) severe hepatic dysfunction, renal dysfunction, heart failure, 2) history of anaphylaxis of drugs we use, 3) pregnancy, 4) lower than 45ml/min of eGFR, 5)lower Body mass index than 22kg/m2 6) patients who are inadequate to enter this study due to the other reasons by physician's judgments