Unique ID issued by UMIN | UMIN000012642 |
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Receipt number | R000014781 |
Scientific Title | Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes |
Date of disclosure of the study information | 2013/12/21 |
Last modified on | 2013/12/20 16:32:05 |
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To assess the efficacy of sitagliptin in type 2 diabetes;1)BS control, 2) side effect outbreak situation such as the hypoglycemia.
Safety,Efficacy
Exploratory
Change of HbA1c
The change in
fasting blood glucose
Glycoalbumin (GA)
The weight
Glucagon
Insulin
C-peptide
Intact pro insulin(insulin/insulin ratio )
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
25mg of 50mg sitagliptin
20 | years-old | <= |
Not applicable |
Male and Female
1) The type 2 diabetes patient whom blood sugar control is inadequate for
2) 20 years old or older
3) Sex no object
4) Outpatient
5) The patient that a written agreement was provided
1)ketotic diabetic coma severe within the past six months or patient with the previous comatose past
2)Severe infectious disease, before and after operation, patient with a serious injury
3)pregnant woman or a woman with the possibility of the pregnancy and the patient whom I am nursing
4)Patient(more than less than creatinine clearance 50ml/min, serum creatinine man 1.5mg/dL more than woman 1.3mg/dL) having renal function disorder more than medium degree
5)Patient during insulin prescription
6)Patient during A-GI,drugs prescription
7)It is a patient with a history of the past of hypersensitivity for an ingredient of the study medicine
8)The patient whom the chief physician assumed inappropriateness for study articipation in planning from medical grounds
200
1st name | |
Middle name | |
Last name | Mitsuyoshi Namba |
Hyogo College of Medicine
Division of Diabetes, Endocrinology & Metabolism
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6592
ninai@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Jyun-ichiro Miyagawa |
Hyogo College of Medicine
Division of Diabetes, Endocrinology & Metabolism
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6592
miyagawa@hyo-med.ac.jp
Hyogo College of Medicine,
Division of Diabetes, Endocrinology & Metabolism
Incretin Society in Hanshin
Non profit foundation
NO
2013 | Year | 12 | Month | 21 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 01 | Month | 23 | Day |
2010 | Year | 02 | Month | 01 | Day |
2014 | Year | 10 | Month | 31 | Day |
2013 | Year | 12 | Month | 20 | Day |
2013 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014781
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