Unique ID issued by UMIN | UMIN000010199 |
---|---|
Receipt number | R000011946 |
Scientific Title | Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study - |
Date of disclosure of the study information | 2013/03/31 |
Last modified on | 2014/09/09 10:29:52 |
Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.
Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.
Japan |
type 2 diabetes mellitus
Medicine in general | Endocrinology and Metabolism |
Others
NO
To compare the continuous glucose profiles byincreasing dose of sitagliptin or switching from sitagliptin to vildagliptin in patients with type 2 diabetes treated with sitagliptin and insulin.
Efficacy
Exploratory
Explanatory
MAGE; mean amplitude of glycemic excursions
1) M-value 2) glucose area under the curve 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
2
Treatment
Medicine |
sitagliptin
vildagliptin
20 | years-old | <= |
Not applicable |
Male and Female
1) patients with type 2 diabetes using sitagliptin (50mg) and insulin for more than 3 months
2) HbA1c 6.2-8.4% (NGSP)
3) written informed consent
1) severe hepatic dysfunction, renal dysfunction, heart failure.
2) history of anaphylaxis of sitagliptin or vildagliptin.
3) pregnancy.
4) patients who are inadequate to enter this study due to the other reasons by physician's judgments.
34
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
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
hmiyoshi@med.hokudai.ac.jp
Hokkaido University Hospital
None
Self funding
None
NO
北海道大学病院(北海道)
2013 | Year | 03 | Month | 31 | Day |
Unpublished
Completed
2013 | Year | 03 | Month | 07 | Day |
2013 | Year | 03 | Month | 31 | Day |
2014 | Year | 06 | Month | 30 | Day |
2013 | Year | 03 | Month | 09 | Day |
2014 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011946