Unique ID issued by UMIN | UMIN000006470 |
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Receipt number | R000007677 |
Scientific Title | Effect of DPP-4 inhibitor on insulin therapy for patients with type 2 diabetes |
Date of disclosure of the study information | 2011/12/05 |
Last modified on | 2014/06/12 11:03:50 |
Effect of DPP-4 inhibitor on insulin therapy for patients with type 2 diabetes
Dpp-4 Inhibitor And Basal insulin-Therapy (DIAB-therapy)
Effect of DPP-4 inhibitor on insulin therapy for patients with type 2 diabetes
Dpp-4 Inhibitor And Basal insulin-Therapy (DIAB-therapy)
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
The study aims to examine effects on glucose metabolism and its related factors (glucagon, C-peptide) with DPP-4 inhibitor "Sitagliptin" for patients with type 2 diabetes who are inadequately controlled blood glucose level treated by insulin mono-therapy or insulin combined with metformin, SU or pioglitazone therapy.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Change in responses of glucose, glucagon and C-peptide with sitagliptin treatment examined by OGTT
Change of HbA1c, fasting plasma glucose, glucagon and C-peptide before and after sitagliptin treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Sitaglipitin
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients with type 2 diabetes who is treated by insulin mono-therapy or insulin and insulin combined with metformin, SU or pioglitazone therapy.
2)HbA1c >=7.5%, <10.0% JDS
3)Age >=20 years (Male and Female)
1)Patients with type 1diabetes (fasting C-peptide less than 0.5mg/dL)
2)Patients with severe ketosis, diabetic coma or precoma within 6 months
3)Patients with severe infections, before or after operation, or serious trauma .
4)Patients with exceeding the moderate renal impairment (sCr: male>=1.5mg/dl, female>=1.3mg/dl).
5)Patients receiving GLP-1 analog
6)Patients receiving oral glucose lowering drug without metformin, SU or pioglitazone
7)Patients who are pregnant, breast-feeding and/or intention to become pregnant
8)Patients with allergy against sitagliptin
9)Other patients determined to be inappropriate by physician
20
1st name | |
Middle name | |
Last name | Takashi Sasaki |
Jikei University School of Medicine Kashiwa Hospital
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
136-1 Kashiwasita, Kashiwa city, Chiba 277-8567 Japan
04-7164-1111
tsasaki-endo@umin.ac.jp
1st name | |
Middle name | |
Last name | Takashi Sasaki |
Jikei University School of Medicine Kashiwa Hospital
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
136-1 Kashiwasita, Kashiwa city, Chiba 277-8567 Japan
04-7164-1111
tsasaki-endo@umin.ac.jp
Jikei University School of Medicine Kashiwa Hospital
None
Self funding
Japan
NO
東京慈恵会医科大学附属柏病院(千葉県) Jikei University School of Medicine Kashiwa Hospital(Chiba)
2011 | Year | 12 | Month | 05 | Day |
Unpublished
Terminated
2011 | Year | 10 | Month | 04 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 10 | Month | 04 | Day |
2014 | Year | 06 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007677
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