Unique ID issued by UMIN | UMIN000006511 |
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Receipt number | R000007669 |
Scientific Title | Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea : a prospective randomized, multicenter, open-label trial |
Date of disclosure of the study information | 2011/10/11 |
Last modified on | 2023/10/19 11:14:32 |
Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea
: a prospective randomized, multicenter, open-label trial
SLIM study
Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea
: a prospective randomized, multicenter, open-label trial
SLIM study
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare effects of sitagliptin addition and sulfonylurea intensification on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Lipid profiles(apolipoproteinB-48,six types of apolipoprotein,total cholesterol,triglyceride,HDL cholesterol,LDL cholesterol,Small dense LDL,RLP-C,LPL,campesterol,sitosterol,cholestarol,lathosterol)
HbA1c,fasting plasma glucose,1.5AG glycoalbumin,body weight change,the frequency of(hypoglycemia)adverse event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
sitagliptin addition group
sulfonylurea intensification group
20 | years-old | <= |
Not applicable |
Male and Female
1)uncontrolled type 2 diabetic patients who are taking oral agents including sulfonylurea(glymepiride at a dose of 2 mg or less per day,glibenclamide at a dose of 1.25 mg or less per day,gliclazide at a dose of 40 mg or less per day)for more than 1 month. Patients whose HbA1c ranges from 6.5% to 8.5% (JDS value)
2)Patients whose Triglyceride is between 120 mg/dL and 400 mg/dL.
3)Patients who go on diets and exercise program.
4)Patients who have been received diabetes treatment for more than 6 months.
5)over 20 years age
6)Gender is not restricted.
7)Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start
1) Patients who had diabetic ketosis, or diabetic pre-coma and coma within 6 months of the study entry.
2) Patients with severe infections, before or after operation, or with serious trauma.
3) Patients with pregnancy, possibility of pregnancy or having a breast feeding.
4) Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl)
5) Patients with serious liver damage.
6) Patients who received insulin therapy.
7) Patients who received incretin-related drugs (DPP4 inhibitor or GLP-1 receptor agonist )
8) Patients who received rapid-acting insulin secretagogues
9) Patients who administered antihyperlipidemic agent for observation period.
10) Patients who had a history of hypersensitive reaction to DPP-4 inhibitor.
11) Patients whom the attending doctor estimated to be ineligible according to the medical rationale.
200
1st name | Shinichi |
Middle name | |
Last name | Oikawa |
Nippon Medical School Hospital
Division of Diabetes, Endocrinology, and Metabolism
1130022
1-1-5 Sendagi, Bunkyo-ku Tokyo
03-3822-2131
shinichi@nms.ac.jp
1st name | Shinichi |
Middle name | |
Last name | Oikawa |
Fukujuji Hospital, Japan Anti-Tuberculosis Association (JATA)
Division of Diabetes
204-8522
3-1-24 Matsuyama, Kiyose, Tokyo
042-491-4111
shinichi@nms.ac.jp
Glucose and Lipid metabolism conference
The Kidney Foundation, Japan
Non profit foundation
Japan
Nippon Medical School
1-1-5, Sendagi, Bukyoku, Tokyo
0338222131
shinichi@nms.ac.jp
NO
日本医科大学付属病院(東京都)、いしかわ日暮里クリニック(東京都)、板垣医院(東京都)、奥田クリニック(東京都)、加藤クリニック(東京都)、武田医院(東京都)、くまのまえ医院(東京都)、目々澤医院(東京都)、森谷医院(東京都)、斉藤医院(東京都)、吉行医院(東京都)、町立八丈病院(東京都)、中島胃腸科内科クリニック(東京都)、国際医療福祉大学(福岡県)、福岡赤十字病院(福岡県)、あげた内科クリニック(宮崎県)、田川市立病院(福岡県)、佐賀記念病院(佐賀県)、乙成内科医院(福岡県)、古賀総合病院(宮崎県)、宮崎病院(宮崎県)、大分大学(大分県)、Tsukasa Health Care Hospital(鹿児島県)、馬場内科クリニック(大分県)、友岡医院(大分県)、柏市立病院(千葉県)、南越谷健身会クリニック(埼玉県)、駅ビル医院せんげん台(埼玉県)、佐々木内科小児科クリニック(東京都)、北小岩胃腸科クリニック(東京都)、西尾久クリニック(東京都)、岡田病院(東京都)、山村クリニック(東京都)、高木病院(福岡県)
2011 | Year | 10 | Month | 11 | Day |
Unpublished
No longer recruiting
2011 | Year | 03 | Month | 30 | Day |
2011 | Year | 05 | Month | 01 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 07 | Month | 01 | Day |
2014 | Year | 09 | Month | 01 | Day |
2014 | Year | 12 | Month | 01 | Day |
2011 | Year | 10 | Month | 10 | Day |
2023 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007669
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