Unique ID issued by UMIN | UMIN000015033 |
---|---|
Receipt number | R000017489 |
Scientific Title | 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- |
Date of disclosure of the study information | 2014/09/03 |
Last modified on | 2017/09/04 14:27:21 |
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-
Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM
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-
Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM
Japan |
type 2 diabetes mellitus
Medicine in general | Endocrinology and Metabolism |
Others
NO
To compare the effect of DPP-4 Inhibitors and Dapagliflozin using CGM in patients with type 2 diabetes treating with insulin
Efficacy
Exploratory
Explanatory
Phase IV
Mean Amplitude of glycemic excursions: MAGE
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Sitagliptin
Vildagliptin
Teneligliptin
Linagliptin
Alogliptin
Saxagliptin
Dapagliflozin
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) patients with type 2 diabetes treating in combination with Inslin and DPP-4 inhibitors 2) HbA1c 6.0-9.0% 3) written informed consent
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
36
1st name | |
Middle name | |
Last name | Hideaki Miyoshi |
Hokkaido University Hospital
Department of Internal Medicine II
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
hidemiyoshi2003@yahoo.co.jp
1st name | |
Middle name | |
Last name | Hideaki Miyoshi |
Hokkaido University Hospital
Department of Internal Medicine II
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
hidemiyoshi2003@yahoo.co.jp
Hokkaido University Hospital
None
Self funding
NO
2014 | Year | 09 | Month | 03 | Day |
Published
https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-017-0255-8
Completed
2014 | Year | 08 | Month | 31 | Day |
2014 | Year | 09 | Month | 07 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2014 | Year | 09 | Month | 02 | Day |
2017 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017489
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |