Unique ID issued by UMIN | UMIN000024511 |
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Receipt number | R000028212 |
Scientific Title | Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes. |
Date of disclosure of the study information | 2016/10/21 |
Last modified on | 2018/11/12 08:45:17 |
Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes.
Cross-Assist
Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes.
Cross-Assist
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To examine the effect of Anagliptin and Sitagliptin on glucose fluctuations using CGM ( continuous glucose monitor)in type 2 diabetic patients with insulin therapy. In addition, to consider the impact on the C-peptide and glucagon, and to examine the relationship with glucose .
Efficacy
Exploratory
Phase IV
Comparison of mean amplitude of glycemic excursions (MAGE) between Anagliptin and Sitagliptin.
1. Comparison of index of glycemic variability by CGM between Anagliptin and Sitagliptin.
(1) Standard deviation (SD)
(2) Mean 24h glucose level
(3) Area under the curve (AUC) by blood glucose level >= 180mg/dL and time
(4) Area over the curve curve (AOC) by blood glucose level < 70mg/dL and time
(5) Maximal blood glucose level in 1 day
(6) Maximal blood glucose level at after breakfast, lunch and dinner
(7) Interquartile range (25%-75%) of blood glucose level
2. Comparison of blood glucose-related indicators by meal tolerance test between Anagliptin and Sitagliptin.
(1) blood glucose level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h)
(2) Glucagon level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h)
(3) C-peptide (fasting, delta 0-30 minutes, incremental AUC0-1h, incremental AUC0-2h)
3. Comparison of CGM and blood glucose-related indicators by meal tolerance test between before and after administration of Anagliptin or Sitagliptin.
4. Comparison of side effects and laboratory values (including the SMBG) between administration groups and their changes between before and after administration.
Interventional
Cross-over
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Anagliptin preceding group: Anagliptin 200mg/day (Day4-8), Sitagliptin 50mg/day(Day9-13)
Sitagliptin preceding group: Sitagliptin 50mg/day (Day4-8), Anagliptin 200mg/day (Day9-13)
20 | years-old | <= |
Not applicable |
Male and Female
The patients who meet all of the following items to the subject of this study .
(1) Patients hospitalized being diagnosed type 2 diabetes mellitus
(2) HbA1c of 7.0 % - 9.9%
(3) Patients on use insulin preparations
(4) 20 years of age or older (regardless of sex)
(5) Patients who provided a written informed concent to participants of this study
Even if meet the inclusion criteria, patients in conflict with any of the following conditions is not the subject of this study.
(1) patient with a history of hypersensitivity for Anagliptin and/or Sitagliptin
(2) patients with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes
(3) patients with severe infection, before or after surgery, or severe external injury
(4) women who are possibility of or during pregnancy, or lactating
(5) patients who can not stop the DPP-4 inhibitors after hospitalization
(6) patients who are taking insulin more than 40U of daily dose
(7) patients who are taking or being required GLP-1 receptor agonists
(8) patients who are inappropriate to participate in research determined by principal investigator or subinvestigator
16
1st name | |
Middle name | |
Last name | Hiroji Kitazato |
Omori Red Cross Hospital
Department of Diabetes and Endocrinology
4-30-1, Chuo, Ota-ku, Tokyo, Japan
03-3775-3111
kitazato-tky@umin.net
1st name | |
Middle name | |
Last name | Hiroji Kitazato |
Omori Red Cross Hospital
Department of Diabetes and Endocrinology
4-30-1, Chuo, Ota-ku, Tokyo, Japan
03-3775-3111
kitazato-tky@umin.net
Omori Red Cross Hospital
Kowa Company.Ltd.
Profit organization
NO
2016 | Year | 10 | Month | 21 | Day |
Unpublished
Terminated
2016 | Year | 04 | Month | 27 | Day |
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 10 | Month | 21 | Day |
2018 | Year | 11 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028212
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