Unique ID issued by UMIN | UMIN000014170 |
---|---|
Receipt number | R000016504 |
Scientific Title | The clinical study to explore the effecs of anagliptin on responses of plasma glucose and lipid in new-onset type 2 diabetic patients |
Date of disclosure of the study information | 2014/06/07 |
Last modified on | 2015/01/07 16:08:18 |
The clinical study to explore the effecs of anagliptin on responses of plasma glucose and lipid in new-onset type 2 diabetic patients
The clinical study to explore the effecs of anagliptin on responses of plasma glucose and lipid in new-onset type 2 diabetic patients
The clinical study to explore the effecs of anagliptin on responses of plasma glucose and lipid in new-onset type 2 diabetic patients
The clinical study to explore the effecs of anagliptin on responses of plasma glucose and lipid in new-onset type 2 diabetic patients
Japan |
New-onset Type 2 Diabetes
Endocrinology and Metabolism |
Others
NO
To explore effects of anagliptin on responses of plasma glucose parameters (plasma glucose and plasma insulin etc.) and lipid parameters (ApoB48 and TG etc.) by MTT in new-onset type 2 diabetic patients.
Efficacy
Confirmatory
Pragmatic
Not applicable
ApoB48(MTT), LDL-c(MTT), plasma glucose(MTT), HbA1c
TC(MTT), TG(MTT), HDL-c(MTT), non-HDL-c(MTT), Body weight, Blood presure, biochemical test, general blood test etc.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Anagliptin 100 mg twice a day 24weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. HbA1c >= 6.5 %
2. LDL-c >= 120 mg/dL
1.Patients who take other oral hypoglycemic agent
2.Patients who are past history of hypersensitivity to anagliptin
3.Patients who are severe ketosis or diabetic coma, precoma, type 1 diabetes
4.Patients who are severe infection or perioperative, severe injury
5.Pregnant or woman of child-bearing potential
6.Patients who are severe renal dysfunction or dialysis ESRD
7.Patients who are severe hepatic dysfunction
8.Patients who are judged as inappropriate for inclusion by phsicians
30
1st name | |
Middle name | |
Last name | Osamu Tomonaga |
Tomonaga Clinic
Diabetes And Lifestyle Center
Shinyon curumu Building 9F, 4-2-23, Shinjuku, Shinjukuku, Tokyo, Japan
03-3351-0032
boss@tomonaga-clinic.com
1st name | |
Middle name | |
Last name | Osamu Tomonaga |
Tomonaga Clinic
Diabetes And Lifestyle Center
Shinyon curumu Building 9F, 4-2-23, Shinjuku, Shinjukuku, Tokyo, Japan
03-3351-0032
boss@tomonaga-clinic.com
Diabetes And Lifestyle Center, Tomonaga Clinic
None
Self funding
NO
医療法人社団ライフスタイルともながクリニック糖尿病生活習慣病センター、東京理科大学薬学部生命創薬科学科、東京女子医科大学糖尿病センター
2014 | Year | 06 | Month | 07 | Day |
Unpublished
Open public recruiting
2014 | Year | 05 | Month | 15 | Day |
2014 | Year | 07 | Month | 01 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 01 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2014 | Year | 06 | Month | 05 | Day |
2015 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016504
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |