Unique ID issued by UMIN | UMIN000017566 |
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Receipt number | R000020337 |
Scientific Title | Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus |
Date of disclosure of the study information | 2015/05/18 |
Last modified on | 2015/05/14 16:47:51 |
Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
Comparison of sitagliptin and glimepiride regarding clinical efficacy and safety
Safety,Efficacy
HbA1c, body weight, hypoglycemia
glycoalbumin, 1, 5-anhydroglucitol, blood pressure, lipids, insulin, proinsulin, adiponectin, leptin, CRP, bone metabolic markers, durability, safety
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
sitagliptin
glimepiride
20 | years-old | <= |
Not applicable |
Male and Female
Patients with type 2 diabetes inadequately controlled with following therapies (HbA1c 6.9~10.4%)
1) diet and exercise therapy
2) treated with glinides or biguanides or pioglitazone monotherapy
3) treated with glinides and biguanides or pioglitazone (dual therapy)
1) kidney dysfunction (serum creatinine > 1.5 mg/dl in men, >1.3 mg/dl in women, or nephrotic syndrome)
2) heart failure, stroke
3) liver dysfunction (serum AST and/or ALT >100mU/ml or liver cirrhosis)
4) respiratory failure (needing oxygen therapy)
5) pregnant women
6) treated with sulfonyureas or alpha-glucosidase inhibitors
7) ketosis, diabetic coma, type 1 diabetes mellitus, severe infection
8) dementia
9) other inadequate patients
200
1st name | |
Middle name | |
Last name | Shoichiro Nagasaka |
Jichi Medical University
Division of Endocrinology and Metabolism
Yakushiji 3311-1, Shimotsuke, Tochigi
81-285-58-7355
sngsk@jichi.ac.jp
1st name | |
Middle name | |
Last name | Shoichiro Nagasaka |
Jichi Medical University
Division of Endocrinology and Metabolism
Yakushiji 3311-1, Shimotsuke, Tochigi
81-285-58-7355
sngsk@jichi.ac.jp
Jichi Medical University
The Waksman Foundation of Japan INC
Non profit foundation
Japan
NO
自治医科大学附属病院(栃木県)、あいそ内科(東京都)、やたがい内科クリニック(栃木県)、小山イーストクリニック(栃木県)、長崎病院(栃木県)、川井クリニック(茨城県)、いたばし糖尿病内科皮フ科クリニック(茨城県)、済生会宇都宮病院(栃木県)
2015 | Year | 05 | Month | 18 | Day |
Unpublished
Completed
2010 | Year | 05 | Month | 25 | Day |
2010 | Year | 05 | Month | 25 | Day |
2014 | Year | 12 | Month | 31 | Day |
2015 | Year | 05 | Month | 14 | Day |
2015 | Year | 05 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020337
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